Negative Pressure Wound Therapy PDF

EWMA
EWMA DOCUMENT:
DOCUMENT:
NEGATIVE
NEGATIVE PRESSURE
PRESSURE
WOUND
WOUND THERAPY
THERAPY
OVERVIEW,
OVERVIEW,
CHALLENGES
CHALLENGES
AND
AND
PERSPECTIVES
PERSPECTIVES
Jan Apelqvist,1, 2 (editor) MD, PhD, Associate Professor
Christian Willy,3 (co-editor) MD, PhD, Professor of Surgery
Ann-Mari Fagerdahl,4 RN, CNOR, PhD
Marco Fraccalvieri,5 MD
Malin Malmsjö,6 MD, PhD, Professor
Alberto Piaggesi,7 MD, Professor
Astrid Probst,8 RN
Peter Vowden,9 MD, FRCS, Professor
1. Department of Endocrinology, University Hospital of Malmö, 205 02 Malmö, Sweden
2. Division for Clinical Sciences, University of Lund, 221 00 Lund, Sweden
3. Department of Trauma & Orthopedic Surgery, Septic & Reconstructive Surgery, Bundeswehr Hospital Berlin, Research and
Treatment Center for Complex Combat Injuries, Federal Armed Forces of Germany, 10115 Berlin, Germany
4. Department of Clinical Science and Education, Karolinska Institutet, and Wound Centre, Södersjukhuset AB, SE-118 83
Stockholm, Sweden.
5. Plastic Surgery Unit, ASO Città della Salute e della Scienza of Turin, University of Turin, 10100 Turin, Italy
6. Clinical Sciences, Lund University, Lund, Sweden.
7. Department of Endocrinology and Metabolism, Pisa University Hospital, 56125 Pisa, Italy
8. Kreiskliniken Reutlingen GmbH, 72764 Reutlingen, Germany
9. Faculty of Life Sciences, University of Bradford, and Honorary Consultant Vascular Surgeon, Bradford Royal Infirmary,
Duckworth Lane, Bradford, BD9 6RJ, United Kingdom
Editorial support and coordination: Niels Fibæk Bertel, EWMA Secretariat

Corresponding author: Jan Apelqvist, [email protected]
The document is supported by unrestricted educational grants from: Acelity, BSN medical, Genadyne, Mölnlycke Health Care,
Schülke & Mayr GmbH, Smith & Nephew and Spiracur.
The document is published as a deliverable for the SWAN iCare project, www.swan-icare.eu, which is partially funded under
the ICT Smart components and smart systems integration programme (FP7-ICT) as part of the Research and Innovation
funding programme by the European Commission.
This article should be referenced as: Apelqvist, J., Willy, C., Fagerdah, A.M. et al. Negative Pressure Wound Therapy – overview,
challenges and perspectives. J Wound Care 2017; 26: 3, Suppl 3, S1–S113.
© EWMA 2017
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MA Healthcare Ltd. nor EWMA will be liable for any errors of omission or inaccuracies in this publication.
Published on behalf of EWMA by MA Healthcare Ltd.

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S2 J O U R N A L O F WO U N D C A R E VO L 2 6 N O 3 S U P P L E M E N T E W M A D O C U M E N T 2 0 1 7
Contents
Abbreviations6 Development of the range of indications: NPWT

1990–201519
1. Introduction 8 Goals of the treatment and the scientific background19
Aim 9 Mechanism of action: NPWT on open wounds 19
Creating a moist wound environment and removal of
2. Methodology and terminology 10 exudate 20
Search history and document development 10 Removal of oedema 20
Terminology10 Mechanical effects on wound edges 20
NPWT induced change in perfusion 22
3. The principles of NPWT 11 Angiogenesis and the formation
Short history 11 of granulation tissue 24
Functional principle of NPWT 11 Change in bacterial count, bacterial clearance and
Example of application 11 immunological effects 24
Mechanism of action of NPWT 12 Molecular mechanisms in wound healing 26
Effect on the wound 12 Effect on topical antibiotic concentrations 27
Handling 12 General points 27
Patient comfort 14 Pressure level/suction strength 28
Functional principle of NPWTi 14 Vacuum source 29
Mechanism of action of NPWTi 14 Intermittent or continuous modus 30
Functional principle of ciNPT 14 Wound fillers 31
Lack of mechanism of action ciNPT 15 Morphology of the wound 31
Differences in mechanism of action in ciNPT and Exuding wounds 31
NPWT 15 Wounds at risk of ischaemia 32
Infected wounds 32
4. Review of the literature evidence on Tendency to the formulation of excessive granulation tissue32
NPWT16 Wound contact layers 32
Literature search16 NPWT and dermal replacement 33
Search period and search keywords 16 Protections of tissue and organs 33
Results 17 Pain treatment 34
Development in the number of annual publications 17 NPWT and adjunct therapies 34
NPWT and evidence-based medicine 17 Indications in specialties 35
Criteria of evidence-based medicine 17 NPWT in acute traumatology and for the closure of
Particularities of NPWT and NPWTi 18 dermatofasciotomy wounds 35
Particularities of ciNPT 18 Periprosthetic infections of the hip and knee joint 37
NPWT in the treatment of osteomyelitis and surgical site
5. Treatment 19 infection37
J O U R N A L O F WO U N D C A R E VO L 2 6 N O 3 S U P P L E M E N T E W M A D O C U M E N T 2 0 1 7 S3
Exposed tendon, bone and hardware 38 Tissue perfusion 58
NPWT in the treatment of acute burns and scalds 39 Oedema 58
Plastic and reconstructive surgery 40 Haematoma and seroma 58
Abdominal surgery 41 Reduction of surgical site infection rate 58
Enterocutaneous fistula 43 ciNPT systems 59
Direct fascial closure 43 When to start, when to stop (achieved endpoint) 60
Hernia development 44
Length of hospital and intensive care unit stay 44 6. Patient perspective 63
Mortality44 Overall quality of life 63
Other aspects 44 Physical aspects 64
Cardiovascular surgery 45 Pain64
Vascular surgery 46 Physical discomfort 64
NPWT of infected blood vessels and vascular grafts 46 Sleep64
Lymphocutaneous fistulas 47 Psychological aspects 65
Non-healing wounds 49 Body image 65
Leg ulcers 49 Stress65
NPWT in leg ulcers 49 Anxiety65
Pressure ulcers 50 Staff competence 66
NPWT in pressure ulcers 50 Social aspects 66
Diabetic foot ulcer 50 Isolation and stigma 66
NPWT in diabetic foot ulcers 51 Family and friends 66
Cautions and contraindications 52 Patient and family
Risk of bleeding 53 caregiver education 66
Exposed vessels and vascular prostheses 53
Necrotic wound bed 53 7. Organisation of NPWT 68
Untreated osteomyelitis 53 Organisation of care 68
Malignant wounds 53 NPWT at different levels 68
NPWT and instillation 53 Short- and long-term goals 68
Functional principle NPWT with instillation 54 Reimbursement 68
Methods of action 54 NPWT in different settings 69
NPWTi versus irrigation-suction drainage 55 Hospital69
Indications for NPWTi 55 Primary care 70
Fluids for NPWTi 55 Home care 70
ciNPT56 Basic concepts in the organisation of NPWT treatment
Literature review: randomised trials 57 71
Mechanism of action of ciNPT 58 Access and service support 71
Lateral tension 58 Inventory and single-purchase models 71
Leasing model 72
Free rental model 72 Wounds treated with NPWT 84
Disposable devices 72 Cost-effectivness 84
Managed service 72 Components of costs 84
Service support 73 Evaluation of comparative and non-comparative studies:
How can continuous high-quality treatment be guaranteed? resource use and economic cost 84
73 Complex surgical, postsurgical wounds and acute or
Service support with regard to the patient 73 traumatic wounds 85
Responsibility74 NPWT in chronic wounds 85
Education and providing a network supporting the patient74 NPWT in diabetic foot ulcers 86
Minimum requirements for staff education 74 General findings 87
Questions to be considered before initiating therapy 75 Methodological considerations 87
A paradigm shift in NPWT: inpatient to outpatient care, a
8. Documentation, communication service to a product 87
and patient safety from the medico-legal
perspective76 10. Future perspectives 89
Implications of cross-sectional NPWT 76 Technological developments 89
Off-label use 77 Hospital-based system with increased sophistication 89
Contractual terms Simplified single use devices 89
and agreements 78 New material for wound fillers 89
Patient safety issues 78 Systems with integrated sensors
Patient safety checklist for out-patient NPWT 78 for long-distance monitoring 90
Communication79 Changes in demand: supporting and constraining factors
Documentation79 91
Legal and litigation issues 80 Expanded indications 91
Increased focus on evidence and cost containment 91
9. Health economics 81 Changes in organisation of care
Organisation of care 81 and community care 92
Factors related to healing of hard-to-heal wounds 82
Technologies in the treatment Appendix114
of wounds 82
Comparing treatment interventions 83
Cost-effectiveness studies 83
Modelling studies 83
Controversies regarding health economic evaluations 83
Health economics and reimbursement with regard to
wounds84
Abbreviations
• ACS: Abdominal compartment syndrome • FGF-2: Fibroblast growth factor-2
• ABRA: Abdominal re-approximation anchor system • HR: Hazard ratio
• ADR: Acellular dermal replacement • HIF: Hypoxia-induced factor
• bFGF: Basic fibroblast growth factor • IE: Immediate early
• BMI: Body mass index • IM: Intermittent mode
• Cdc42: Cell division control protein 42 • ICU: Intensive care unit
• ciNPT: Closed incision negative pressure therapy • LC-MS/MS: Liquid chromatography mass
spectrometry
• CI: Confidence interval
• LUs: Leg ulcers
• CABG: Coronary artery bypass grafting
• MRSA: Meticillin-resistant Staphylococcus aureus
• CRP: C-reactive protien
• NBC: Nucleated blood cells
• DRG: Diagnosis related groups
• NICE: National Institute for Health and Care
• DSWIs: Deep sternal wound infections Excellence
• DFUs: Diabetic foot ulcers • NPWT: Negative pressure wounds therapy
• ECF: Enterocutaneous fistula • NPWTi: NPWT with instillation
• EPUAP: European Pressure Ulcers Advisory Panel • NO: Nitric oxide
• EWMA: European Wound Management Association • OA: Open abdoman
• ERK: Extracellular signal-regulated kinase • PDGF Platelet derived growth factor
• FDA: US Food and Drug Administaration • PHMB: Polyhexamethylene biguanide
• PVA: Polyvinyl-alcohol
• PU: Pressure ulcer
• PHI: Private Health Insurance
• QoL: Quality-of-life
• RCTs: Randomised controlled trials
• RR: Relative risk
• SHI: Statutory health insurance
• SSD Silver sulfadiazine treatment
• SSI: Surgical site infections
• SWD: Surgical wound dehiscence
• SDR: Synthetic dermal replacement
• TAC: Temporary abdominal closure
• VEGF: Vascular endothelial growth factor
• WBP: Wound bed preparation
• VEC: vascular endothelial cell
1. Introduction
S
ince its introduction in clinical practice in patient morbidity and health-care costs can be
the early 1990’s negative pressure wounds significantly reduced.
therapy (NPWT) has become widely used
in the management of complex wounds in both There is further a fundamental confusion over
inpatient and outpatient care.1 NPWT has been the best way to evaluate the effectiveness of
described as a effective treatment for wounds of interventions in this complex patient population.
many different aetiologies2,3 and suggested as This is illustrated by reviews of the value of
a gold standard for treatment of wounds such various treatment strategies for non-healing
as open abdominal wounds,4–6 dehisced sternal wounds, which have highlighted methodological
wounds following cardiac surgery 7,8
and as a inconsistencies in primary research. This situation
valuable agent in complex non-healing wounds.9,10 is confounded by differences in the advice given
Increasingly, NPWT is being applied in the primary by regulatory and reimbursement bodies in various
and home-care setting, where it is described as countries regarding both study design and the
having the potential to improve the efficacy of ways in which results are interpreted.
wound management and help reduce the reliance
on hospital-based care.11 In response to this confusion, the European
Wound Management Association (EWMA) has
While the potential of NPWT is promising and the been publishing a number of interdisciplinary
clinical use of the treatment is widespread, high- documents15–19 with the intention of highlighting:
level evidence of its effectiveness and economic
benefits remain sparse.12–14 • The nature and extent of the problem for wound
management: from the clinical perspective as
The ongoing controversy regarding high-level well as that of care givers and the patients
evidence in wound care in general is well known.
There is a consensus that clinical practice should • Evidence-based practice as an integration of
be evidence-based, which can be difficult to clinical expertise with the best available clinical
achieve due to confusion about the value of evidence from systematic research
the various approaches to wound management;
however, we have to rely on the best available • The nature and extent of the problem for wound
evidence. The need to review wound strategies management: from the policy maker and health-
and treatments in order to reduce the burden of care system perspectives
care in an efficient way is urgent. If patients at risk
of delayed wound healing are identified earlier The controversy regarding the value of various
and aggressive interventions are taken before the approaches to wound management and care is
wound deteriorates and complications occur, both illustrated by the case of NPWT, synonymous
with topical negative pressure or vacuum therapy and provide overview of its implications
and cited as branded VAC (vacuum-assisted closure) for organisation of care, documentation,
therapy. This is a mode of therapy used to encourage communication, patient safety, and health
wound healing. It is used as a primary treatment of economic aspects.
chronic wounds, in complex acute wounds and as
an adjunct for temporary closure and wound bed These goals will be achieved by the following:
preparation preceding surgical procedures such as
skin grafts and flap surgery. 1. Present the rational and scientific support for
each delivered statement
Aim 2. Uncover controversies and issues related to the

An increasing number of papers on the effect use of NPWT in wound management
of NPWT are being published. However, due to
the low evidence level the treatment remains 3. Implications of implementing NPWT as a
controversial from the policy maker and health- treatment strategy in the health-care system
care system’s points of view—particularly with
regard to evidence-based medicine. 4. Provide information and offer perspectives of
NPWT from the viewpoints of health-care staff,
In response EWMA has established an policy makers, politicians, industry, patients
interdisciplinary working group to describe and hospital administrators who are indirectly
the present knowledge with regard to NPWT or directly involved in wound management.
2. Methodology and
terminology
O
ur methodology for this document Each chapter of the document has been divided
comprises a general literature review between the authors, who have provided feedback
supplemented with individual searches in an edited draft. This process has been repeated
on the specific topics along with the addition of several times; the group edited the final document
the authors’ clinical expertise. Most research with and all authors agreed on all controversies,
regard to wound healing and NPWT has been related statements, and discussions. The final draft was sent
to acute wounds and to a lesser extent chronic/ to resource persons, EWMA council members, and
problematic/non-healing wounds.12,13,15,20,21 supporters to comment on the draft in an internal
validation process.
The opinions stated in this document have been
reached by a consensus of the authors involved, Besides an initial literature search, a specific
based on evidence-based literature, published literature search was made with regard to the study
research articles and clinical experience and these design, endpoints, and outcomes in comparative/
opinions have been externally reviewed. This paper randomised controlled trials (RCTs) of NPWT.
is not purely evidence-based or an evaluation of
existing products, as this would compromise the
primary objective. Terminology
The term NPWT refers to a controlled negative
Since the authors are residents of Europe and pressure (sub-atmospheric) system that is applied
EWMA is a European association, the document topically onto the wound. The wound is filled with
will particularly take European patients and health- a porous material (wound filler) and hermetically
care systems into consideration. The document will sealed with an airtight adhesive polyurethane
focus on the human (clinical) perspective; however, drape. A drain connects the wound filler to the
animal related studies will be mentioned when vacuum source that delivers a negative pressure.
applicable. The suction is propagated from the vacuum source
to the wound bed, leading to a negative pressure in
the filler and removal of exudate. Two more recent
Search history and document modifications of NPWT are also discussed:
development
• ‘NPWT with instillation’ (NPWTi), NPWT with
As a general conclusion with regards to the a repeated computer-controlled retrograde
literature search we acknowledge that more high- instillation mostly of an antiseptic or antibiotic
level evidence is needed to further support the substance as well as saline into the sealed wound.
content of this document. However, until this
has been provided, we have to rely on existing • Same applies for the closed incision negative
information and experience. pressure therapy (ciNPT) when NPWT is applied
3. The principles of NPWT
N
PWT can be regarded as an established 2000, Joseph et al.26 and McCallon et al.27 compared
wound care method in routine clinical use the efficacy of NPWT with standard methods
since the mid to late 1990’s. Stated simply, of treatment of wounds, showing a statistically
the method consists of application of negative significant reduction in the size of the lesions and the
pressure (usually −75 to −125 mmHg) to foam that time to healing in the group receiving NPWT. The
has been placed inside the wound. Immediate first wound filler to be widely available for NPWT
sealing of the wound with an airtight adhesive was the polyurethane foam.24 Gauze appeared in
drape prevents subsequent entry of air from the an article on NPWT by Chariker in 1989.28 In 2007,
environment, hence the term ‘vacuum sealing’. cotton gauze preimpregnated with 0.2 % antiseptic
polyhexamethylene biguanide (PHMB), was
In the following sections the principle of introduced as a commercially available product. An
conventional NPWT and the modifications NPWTi important development in the field of NPWT is the
(1996) and ciNPT (2005), will be presented. introduction of new materials for wound fillers.
Short history Functional principle of NPWT

In 1979, a suction and irrigation system for the The principle of NPWT involves extending the
treatment of wounds was described in a Russian usually narrowly defined suction effect of drainage
publication. In 1992, in Germany, patients with
22
across the entire area of the wound cavity or surface
exposed fracture were treated with a negative using an open-pore filler that has been fitted to
pressure system. Initially, the loss of substance was the contours of the wound. To prevent air from
filled with a polyvinyl-alcohol (PVA) foam, (later being sucked in from the external environment,
there was a change towards more polyurethane), to the wound and the filler that rests inside or upon
which drainage tubes were connected all wrapped the wound are hermetically sealed with an airtight
in a transparent film. The drainage pipes were adhesive polyurethane drape that is permeable to
connected to a suction device, and a negative water vapour, transparent, and bacteria proof. A
pressure was applied. This system allowed the
23
connection pad is then applied over a small hole
efficient cleansing of the wound and a significant that has been made in the drape and connected to a
proliferation of granulation tissue. In 1997, the work vacuum source by means of a tube (Fig 1).
of Argenta and Morykwas24 validated NPWT in an
animal (pig) model and subsequently on patients
with ulcerative lesions.25 These studies reported the Example of application
positive effect of the negative pressure on blood A patient case is presented to illustrate the individual
flow in the wound and in the adjacent tissue (via steps involved showing the hygienic and comfortable
Doppler evaluation), on the rate of granulation tissue management of an infected and unstable sternal
formation and on the reduction of bacterial load.24 In wound in a 73-year-old patient (Fig 2).
Mechanism of action of NPWT • Effective biochemical reduction of the fluid
The following effects on wound healing and the concentration of wound healing-impairing
affected tissue, resulting from applied suction proteases (such as elastase)—in the first days
that acts evenly on the entire wound surface, are
considered to be the primary clinically significant • Reliable, continuous removal of wound exudate
benefits of NPWT. 23,25,29–35
(and, consequently, fewer dressing changes)
within a closed system
Effect on the wound
• Reduction of the wound area due to negative • Pressure-related reduction of interstitial
pressure acting on the foam, pulls together the oedema with consecutive improvement of
edges of the wound (wound retraction) microcirculation, stimulation of blood flow
and oxygenation.
• Stimulation of granulation tissue formation in an
optimally moist wound environment; in several Handling
situations even over bradytrophic tissue such as • Hygienic wound closure—bacteria proof
tendons and bone NPWT was able to stimulate wound dressing for sealing the wound so no
granulation tissue formation external bacteria can enter the wound and the
patient’s own wound bacteria are not spread.
• Continuation of effective mechanical wound This is particularly important in the event of
cleansing (removal of small tissue debris by contamination with problematic bacteria, as in
suction) patients with meticillin-resistant Staphylococcus
Fig 1. Principles of NPWT

Wound/tissue defect
a b
The wound (a) and a foam, cut to fit to the wound geometry, which is placed inside the wound (b)
c d
The wound is sealed airtight with a thin adhesive drape (c); with the attached ‘suction pad’ (connecting pad) including the
drainage tube (d)
Suction 0 mmHg
e f
Suction −125 mm/Hg
The wound is hermetically sealed with a thin adhesive drape and connected to the vacuum source by means of the attached
‘suction pad’ (suction strength 0 mmHg, (e). At suction strength −125 mmHg, the foam has collapsed and the exudate
collection reservoir is already partly filled (f)
Fig 2. Example of application
a b
Infected sternal wound, unstable sternum after sternotomy, fibrinous membranes and necrosis, particularly in the cranial part of
the wound (a). Debridement and irrigation of the wound (b)
c d
a
The foam is fitted to the shape of the wound (black polyurethane foam) (c). Fixation of the foam to the lateral wound edges
with skin staples (this can be done with a skin suture or without any fixation) (d)
e f
Sealing of the wound with an airtight transparent adhesive drape (e). A small hole is cut into the drape (f)
g h
The connecting pad is applied onto this hole (g). Wound after connection of the vacuum source at −125 mmHg (h). Compared with
the initial finding (g), there is a distinct narrowing of the wound due to the ‘shrinking’ of the foam caused by suction
aureus (MRSA)-infected wounds. Thus, it example every three hours, without burdening the
also reduces the risk of cross-infections and patient or nursing staff. Using today’s computer-
development of resistance within the hospital controlled programmable therapy units it is possible
to automatically control the instillation therapy
• Transparent dressing permits continuous clinical (amount of fluid, duration of instillation, time
monitoring of the surrounding skin through the for which the substance is allowed to take effect,
film with which the wound has been sealed frequency of the therapy, etc.). NPWTi has been
successfully used for the treatment of acute wound
• Odourless and hygienic dressing technique; infections after surgical wound debridement.35,37–41
constant seeping through the dressing onto the Nowadays, some authors suggest that non-infected
patient’s clothing and bedding can be avoided, wounds might also show a benefit in healing
reducing demands on the nursing staff when treated by NPWTi using saline solutions in
comparison with conventional NPWT or standard
• Reduction in the number of required dressing moist wound treatment.42,43
changes (only necessary every two to three
days), which reduces nursing time requirements,
particularly in patients with exudating wounds. Mechanism of action of NPWTi
Instillation therapy is performed during NPWT by
Patient comfort instilling the desired solution into the foam via a
dedicated tube system and then, after a set time
• Easy and early patient mobilisation during which the instillation is left to take effect
with no suction applied, removing the solution
• Visually appealing dressing method due to clean, by suction and continuation of the actual
exudate-free dressing conditions even during NPWT. In principle, this alternation between
mobilisation. NPWT and instillation periods can be repeated
as often as desired. In fact, it is suggested that
the instillation should be performed several
Functional principle of NPWTi times a day for sufficient effect according to a
Instillation therapy is a modification of conventional controlled time sequence. As an example, for an
NPWT for the complementary treatment of acute antimicrobial effect:
and chronic wound infections after initial surgery.
Instillation therapy can be performed according • Instillation period of the saline/antiseptic/topical
to the method of Fleischmann et al. to deal with antibiotic solution approximately 10–30 seconds
any residual contamination of the wound. 35–37
This
modification involves the retrograde instillation • Dwelling period (depending on the time the
of an antiseptic or antibiotic substance, such as solution needs to be effective, such as 20 minutes)
pyrrolidinone homopolymer compound with
iodine or octenidine dihydrochloride, into the • Suction period, such as 2–3 hours.
sealed wound. Instillation therapy has been
used clinically since 1996. Since then, several
Functional principle of ciNPT
refinements in equipment have provided the option
of automatically controlled instillation therapy. Traditionally, surgeons have closed surgical incisions
This permits constantly controlled instillation, for with primary intention using sutures, staples, tissue
adhesives, paper tape, or a combination of these Differences in mechanism of
methods. Recently, surgeons are using negative
action in ciNPT and NPWT
pressure therapy immediately postoperatively over
closed incisions in a variety of clinical settings to It is important to recognise that clear differences
prevent surgical site infections (SSIs). ‘Closed incision exist between the mechanism of action of ciNPT
negative pressure therapy’ refers to any type of and NPWT on open wounds. The evidence for
NPWT over closed incisions. Since 2006, numerous ciNPT supports the reduction of lateral tension and
published studies have reported improved incisional haematoma or seroma, coupled with an acceleration
outcomes using ciNPT across surgical disciplines. of the elimination of tissue oedema.
Conventional NPWT on open wounds causes a

Lack of mechanism mechanical stress of the wound edges that alters
of action ciNPT tissue perfusion, resulting in angiogenesis and the

formation of granulation tissue. To the knowledge
ciNPT appears to manage the surgical incision by of the authors, no such evidence exists for ciNPT,
reducing incision line tension, decreasing oedema, in fact, the literature shows there is no altered
and providing an airtight seal, beneficial in perfusion.44 However, ciNPT is reported to have a
preventing incision complications. good clinical outcome.
4. Review of the literature
evidence on NPWT
M
any national and international peer- (we used the ‘snowball’ method and searched the
reviewed articles on the subject of NPWT references of the self-researched publications).
have appeared in the medical literature Irrespective of the evidence of the publications
and it has been the subject of congresses worldwide. (all languages), the search involved randomised
An analysis of the literature shows that a large clinical and experimental studies, systematic and
proportion of the publications on NPWT in all non-systematic reviews, meta-analyses, expert
surgical disciplines are congress reports, opinions opinions, case reports, experimental papers (animal
and experience reports, which were not submitted and human studies) and result reports of consensus
to a formal peer-review process. The following conferences. The universally valid biometric
analysis of the available literature dealing with requirements—such as suitability of the primary
NPWT provides an overview of the peer-reviewed endpoints for the statement, sufficient number of
literature published to date. Attention is directed to cases, representativeness of the study population,
the following: relevant dosages and significance of the results—
were taken into account for an assessment of the
• Development of the annual number of studies. However, where necessary, the assessment
publications also considered the particular nature of the question
addressed. In these cases, the assessment criteria
• Language area where the publications originated played a secondary role. It should be mentioned,
that for some of the questions addressed a search
• Proportion of studies on the pathophysiological was also carried out for relevant theses, unpublished
background of NPWT research reports and congress minutes.
• ‘Quality’ of the studies under the criteria of

evidence-based medicine. Search period and search
keywords
Literature search The search covered papers published in the period
In order to identify publications that satisfy at least up to 31 December 2015. The keywords included
a minimum quality standard, only papers that met (‘all fields’-search): ‘negative pressure wound
the following criteria were selected: published in therapy’ ‘NPWT’, ‘vacuum assisted closure’, ‘VAC
a journal with clearly defined author guidelines therapy’, ‘V.A.C. therapy’, ‘vacuum dressing’,
and a defined description of the peer-review ‘topical negative pressure therapy’, ‘TNP therapy’
procedure. The analysis was based on the results of (the abbreviation of topical negative pressure),
a computerised MEDLINE (with PubMed) search ‘sealed surface wound suction’, ‘vacuum sealing
as well as an extensive hand search, in which the therapy’, ‘subatmospheric pressure therapy’, foam
references of all available citations were also assessed suction dressing’. (See Table, appendix 1).
Results There were 27 RTCs remaining (Tables, appendix 3
Development in the number and 6).
of annual publications
We identified 3287 publications, published in 685 Prospective randomised studies in surgery are
different journals between 1990–31 December rare.46,47 In trauma surgery, the rate is approximately
2015 (see appendix 2, 3 and 4). 3 % of all publications. In this NPWT context there
is remarkable disproportion between the number
NPWT and evidence-based medicine of systematic reviews (n=68) and the amount of
Criteria of evidence-based medicine randomised studies assessing the clinical usefulness
The evaluation of the relevant literature was based of NPWT in comparison with standard procedures
on the classification of the Oxford Centre for (n=57). Thus there are more studies searching for
Evidence-Based Medicine (CEBM).45 evidence in the literature than studies creating the
proof of effectiveness/efficiency of NPWT in the
Evaluation based on CEBM shows that over 85 % are clinical routine!
case series or case reports, evidence levels 4 and 5.
This leaves ~200 published articles with an evidence One reason for this situation is a gap between
level higher than 4 (table x, appendix 5). There were clinical practice, on the one hand, and
271 comparative studies. Continuing this selection scientific findings and evidence-based medicine
process for only RCTs (n=76) being focused on requirements, on the other. Clinicians who use
primary endpoint analysis using for patient’s benefit a new treatment method and find it effective
relevant endpoints: will usually publish case reports or observational
studies reflecting the treatment success on
• Time to definitive wound closure the basis of their experiences. They will focus
attention on an exact description of the method
• Time to prepare for ‘ready for surgery’ and potential risks and benefits. Evidence-based
medicine principles will play only a minor role in
• Graft take rate their work. Only very rarely will clinicians find the
time and support to be able to conduct an RCT
• Graft quality with all the additional tasks involved and at the
same time perform their daily work. The fact that
• Delayed primary fascial closure (closure of open many ‘renowned’ journals have published these
abdomen) articles reflects the importance NPWT even at this
relatively low evidence level. It is thus explainable
• Rate of surgical site infections and understandable that approximately 66 %
of the international peer-reviewed literature on
• Mortality NPWT consists of case descriptions.
Particularities of NPWT and NPWTi Particularities of ciNPT
NPWTi is a further development and modification There is a rapidly emerging literature on the
of conventional NPWT for the complementary preventive effect of ciNPT in SSI. Initiated and
treatment of acute and chronic wound infections after confirmed first with An RCT in orthopaedic
initial surgery. NPWTi has been used clinically since trauma surgery,48 studies in abdominal, plastic,
1996, and between and during 1999–2013 several vascular and cardiothoracic surgery with good
refinements in equipment have provided the option effect on SSI rate reduction have been reported.
of automatically controlled instillation therapy. The There are currently 116 peer-reviewed articles
first publications date from 1998 (Fleischmann et that have been published on the subject of NPWT
al).23 There are currently 105 peer-reviewed articles in combination with closed incisions (keywords:
that have been published on the subject of NPWT in ‘closed incision management’, ‘active incision
combination with instillation (keywords: ‘instillation’, management’, ‘prevention’, ‘prophylaxis’; as
‘instill’, ‘Irrigation’; as of 31 December 2015, see of 31 December 2015, see figure, appendix 7)
figure, appendix 7) and seven studies comparing and 27 studies comparing NPWTi with standard
NPWTi with NPWT or standard therapies, however, incisional wound management (RCTs n=8).
there are no RCTs. NPWTi, the modifications and the ciNPT, the modifications and the indications are
indications are explained in more detail on page 54 explained in more detail on page 56 (Chapter 5,
(chapter 5, section on NPWTi). section on ciNPT)
5. Treatment
Development of the range of age), under clinically difficult situations (life-
indications: NPWT 1990–2015 threatening abdominal sepsis) and high-risk

situations such as long-term infections, to
T
he first clinical experiences with NPWT as prevent complications (e.g. ciNPT - see page
it is used today occur from 1987 onwards 56) and is based on newer technologies, such
when acute traumatic soft tissue defects as computer-assistance, small hand-held and
and acute and septic wounds were treated with mechanically driven devices as well as NPWT
this method. Publications followed in the early combined with instillation (NPWTi – see page 53)
1990’s. Very soon, the range of indications was
extended to chronic wounds such as leg ulcers
(LUs), decubitus ulcers; see also flowchart, Goals of the treatment
appendix 8). Since 2000, there has been a
and the scientific background
marked extension of the range of indications
including severe dermatological syndromes and Mechanism of action:
problematic wounds in vascular surgery as well NPWT on open wounds
as an increasing use in plastic surgery. From NPWT acts in different ways to promote wound
then on, the spectrum of indications has been healing. The wound is subject to suction pressure
continuously expanded so that NPWT is today that is propagated through the wound filler to the
used in almost all areas of surgery. wound bed. This suction drains exudate from the
wound and creates a mechanical force in the wound
There are more than 100 indications identified edges that result in an altered tissue perfusion,
for NPWT. In visceral surgery, entero- and angiogenesis and the formation of granulation
lymphocutaneous fistulas and open abdomens tissue. Some of the mechanisms of action have been
are treated with NPWT. In trauma surgery, the demonstrated experimentally and clinically. The
range of indications has been extended to implant effects can be summarised as follows:
infections in the fields of endoprosthetics and
spinal surgery, while burns (burns of the hand, • Isolating the wound from infection of external
fixation of skin substitutes) are found to be an origin
ideal indication for NPWT. In visceral and thoracic
surgery, NPWT is not only used on the body • Creating a moist wound environment
surface for the management of septic wounds or
defect regions but also when there are problematic • Pressure transmission and removal of exudate
conditions deep in the body cavity (bronchial
stump insufficiency, pancreatic trauma). NPWT • Removal of oedema
is now used in extreme age (newborn, very old
• Mechanical stress of the wound edges NPWT causes compression of the tissue closest
to the surface of the wound, which is believed
• Altered blood perfusion to reduce interstitial oedema.51,52 There are few
studies but there is widespread agreement among
• Angiogenesis and the formation of granulation clinicians that NPWT eliminates tissue oedema.
tissue However, there are only a handful studies that have
directly measured this effect,24,25,53 NPWT resulted
NPWT isolates the wound and prevents it from in increased perfusion in patients with bilateral
being infected by the external environment. hand burns and it was concluded that oedema was
NPWT also involves sealing the wound with an reduced.54 In an experimental study on the pig septic
airtight drape that will create a moist wound open abdomen, it was shown that the NPWT-treated
environment. pigs had less tissue oedema than those treated by
passive drainage.55 High-frequency ultrasound has
The mechanisms of action of the combination of been used to quantify reduction of oedema in the
NPWT and instillation and the special mechanisms periwound tissue in a small group of pressure ulcer
of ciNPT will be described in chapter 5 page 53–60. (PU) patients on commencement of NPWT.56 Most
probably, oedema and exudate are reduced both
Creating a moist wound environment and directly through mechanical removal of excess fluid,
removal of exudate and indirectly through altered microcirculation.
A moist environment is vital in wound healing
as it facilitates the re-epithelialisation process. Mechanical effects on wound edges
However, in an overly moist wound, exudate NPWT mechanically stimulates the wound bed,57,58
may cause infection and maceration, leading to and produces a suction pressure on the wound
damage to the wound edge. Removal of exudate edges that will push onto the wound and contract
is important to prevent the accumulation of it.24,25,50 The mechanical effects lead to tissue
necrotic tissue and slough that tend to continually remodelling that may facilitate wound closure.
accumulate in wounds and alter the biochemical It also has been found that the wound tissue and
and cellular environment.49 Stagnant wound the filler material interact on a microscopic level
fluid may also increase the risk of abscesses. The to micro deform the tissue. These mechanical
accumulation of necrotic tissue or slough in deformations58–62 lead to a number of biochemical
a wound promotes bacterial colonisation and reactions and gene transcriptions. The wound bed
hinders repair of the wound. NPWT balances these is drawn into the pores of the foam or inbetween
effects, providing a moist wound environment the threads of the gauze.58 These mechanical effects
while removing excess fluid. Several studies have affect the cytoskeleton of the cells and initiate a
shown that NPWT removes exudate.24,25,50 cascade of biological reactions that may accelerate
the formation of granulation tissue and subsequent
Removal of oedema wound healing.
Oedema causes increased pressure on the wound
tissue, which in turn compromises the microvascular The mechanotransductive stimulus on the wound
blood flow, reducing the inflow of nutrients and bed that is exerted by the foam under suction is
oxygen. This reduces resistance to infections and regarded as an important effect of NPWT.24,63–67
inhibits healing, thus, in order to facilitate wound Mechanical tissue deformation stimulates the
healing, it is important to reduce tissue oedema. expression of angiogenic growth factors and
receptors, such as vascular endothelial growth be drawn very cautiously, if at all.66 Also, it has not
factor (VEGF), VEGF receptors and the angiopoietin been proven to date that NPWT produces a pure
system receptors.59,61,68–73 In vitro studies have stretching stimulus. Because of the filler architecture,
shown that the stretching of endothelial cells it must rather be assumed that positive pressure
stimulates blood vessel formation.74,75 values (on the pore wall resting on the tissue) and
negative pressure values (in the region of the actual
The frequently cited explanation of the pore) are generated at the same time. To date, there
mechanical effects of NPWT is based on the are no studies on the spatial pressure distribution
reviews by Ingber,76 which describes the current in the mm and μm ranges. In any case, when
state of knowledge on the transduction of developing a concept of the principle of action of
physical forces into biochemical responses on NPWT, one cannot work on the assumption that
a cellular level. The conceptual model derived there is only one single stretching stimulus on cells.
from these data describes how external forces, Instead of only one type of force acting on the cells,
such as subatmospheric pressure, act on the cell it is much more likely that pressure and/or shear
through the extracellular matrix by means of stress (tangential force vector) and/or stretching
transmembrane bridges (membrane molecules forces act on the cells.
such as the integrins), causing the release of
intracellular second messengers. According to the A deeper understanding of the heterogeneity of
model, these messengers lead to the immediate the mechanical forces acting on the cells of the
activation of immediate early (IE) genes, followed filler/wound interface is conveyed by Saxena and
by matrix molecule synthesis and cell proliferation, Orgill.58 In a computer simulation, they calculated
as described in the papers by Sadoshima et al., the stretching stimulus that acts on the individual
Vandenburgh et al. and Bauduin-Legros et al.65,77–80 cells in the region of the foam pore wall and the
foam pore space. The verification by histological
Mechanical stress also promotes the production examination revealed that the calculated results
of extracellular matrix components such were valid. They were able to demonstrate that the
as collagen, elastin, proteoglycans and cells in the region of the pore wall are ‘squeezed’
glycosaminoglycans.61,73,81 A murine study revealed and the cells in the immediate vicinity of the pore
a significant increase in dermal and epidermal wall are stretched greatly, while the cells in the
nerve fibre densities in wounds treated with NPWT, pore space are stretched by approximately 5–20 %.
indicating that the treatment may promote nerve The authors explain that chemical stimuli such
production.82 It may be important to control the as soluble growth factors and the attachment
state of stress and strain in the wound bed in order to extracellular matrix proteins alone are not
to affect the wound healing effects of NPWT. 76,83–85
sufficient for the proliferation of cells, but that
there must also be a mechanical context, which is
The studies of Ingber do not investigate the effects usually associated with varying states of isometric
of NPWT on the cell. The application of the study tension of the cells. Furthermore, this state
results about stretching cell models is merely based usually no longer exists in wounds but NPWT can
on the assumption that NPWT also induces a compensate for this lack of mechanical stimuli.
stretching stimulus. Against the background of the They refer to the literature in which stretching
diversity of cell responses to mechanical stimuli stimuli indeed had a proliferative effect.80,86,87 In
moving in the same direction, as mentioned by their model, they actually calculated stretching
Sumpio, such a conclusion by analogy may only stimuli, as an effect of NPWT, of a magnitude
(5–20 %), which had been found to be favourable Laser Doppler flow measurements were performed
in other studies. They did not discuss, that in other studies.90–93 Although there are some
according to their calculations, individual cells inconsistencies, it still appears possible to derive
experience stretching stimuli of over 110 %, while a general hypothesis regarding the perfusion
other cells are compressed substantially. Assuming situation during NPWT. While a homogeneous
that in a cross-section of the pore, only 60 % of response to the increase in suction to –125 mmHg
the cells actually experience a stretching stimulus was observed by Morykwas et al. (increase in
of 5–20%, this means that only one-third of all perfusion and decrease to baseline levels within
cells within the wound (area=πr2) experience a the first 10 minutes),24,89 Rejzek et al. found more
favourable effect. This was not discussed. heterogeneous curve patterns.91 They observed
different responses to identical influences and
It is necessary to consider that wounds are not demonstrated that an increase in suction led
simple single-phase linear elastic layers. As Lohman to both an increase and a decrease, and also to
et al. discussed, this model obfuscates the role of a constant pattern of perfusion. The question
fluid shear stresses and electrokinetic streaming whether these differences, observed using the
potentials (movement of ions in solution) in same measuring method, relate to methodical
stimulating responses. Mechanical deformation differences between the two studies (animal
by external NPWT will also result in fluid flow experiment in five pigs / human experiment
within the interstices of the matrix.88 Using NPWT, in seven patients; artificial, uncomplicated
there are stretching, shearing and electromagnetic acute wound after skin excision/venous ulcers
effects, probably with certain differences between subcutaneous measurement/measurement in the
continuous and intermittent therapy. wound edge and transcutaneous measurement)
cannot be answered. On the whole, a direct
NPWT induced change in perfusion increase in flow after application of suction cannot
Morykwas and co-workers found that continuous be reliably derived from the diagrams presented by
NPWT application of suction resulted in an the two groups.
average increase in new granulation tissue
formation of approximately 60 %, significantly The presumed increase in perfusion would result
increased compared to controls (moist wound in an improved oxygenation of the wound edges.
management). 24,89
The research group reported However, the research group of Lange et al. was
that there was no positive effect on perfusion unable to demonstrate any changes in tissue
when a continuous suction of −125 mmHg was oxygen partial pressure during NPWT with the
applied. After an initial increase in perfusion, polarographic measuring technique.94 Studies
the increased blood flow decreased permanently by Banwell and Kamolz54,95 and Schrank et al.96
to baseline levels or even below baseline after also do not demonstrate an NPWT associated
only 10 minutes, reaching a state of normo- or increase in flow. These groups found indications
hypoperfusion. Based on these results, they that NPWT is advantageous in the early stage
suggested that NPWT increases perfusion in therapy of burn wounds (>24 hours after initiation
the wound, contributing to wound healing—a of therapy) for the nutritive perfusion status of
conclusion that has been cited in almost every the tissue. However, one must bear in mind that
subsequent publication. This raises the question: NPWT exerts compression on the tissue which in
Does hypo- or hyperperfusion of the wound turn usually responds with increased swelling after
tissue occur during NPWT? a trauma or burn injury. So, the improvement of
nutritive perfusion due to NPWT is more likely the smaller. The explanation for this finding may be
result of an indirect anti-oedematous effect that that subcutaneous tissue collapses more easily
promotes perfusion. during pressure, which results in a large zone of
hypoperfusion proximal to the wound.98
However, a different explanation is also
conceivable. In these studies, perfusion was not Against this background the same group examined
measured until the compressive NPWT dressing the effects of NPWT on peristernal soft tissue blood
had been removed. As the dressing exerts a more flow after internal mammary artery harvesting.
or less strong pressure on the tissue, depending on For this, microvascular blood flow was measured
the intensity of the applied suction, the reported using laser Doppler velocimetry in a porcine
increased perfusion could simply be the result sternotomy wound model. The effect of NPWT on
of reactive hyperaemia. The measurement after blood flow to the wound edge was investigated
removal of the dressing is no proof that perfusion on the right side, where the internal mammary
is increased when the NPWT dressing is in place. artery was intact, and on the left side, where the
This explanation has also to be taken into account internal mammary artery had been removed. The
when interpreting the results of Chen et al.97 They investigators observed that before removal of the
observed increasing capillary calibre and blood left internal mammary artery, the blood flow was
volume ‘during’ NPWT by analysing the wound similar in the right and left peristernal wound
bed microcirculation by means of microscope and edges. When the left internal mammary artery
image pattern analysis. was surgically removed, the blood flow on the left
side decreased, while the skin blood flow was not
Assessing inguinal and peristernal wounds in affected. Then NPWT (suction pressure −75 mmHg
recent studies addressing this question, the and −125 mmHg) induced an immediate increase
research group of Wackenfors et al.93,98 showed that in wound edge blood flow similar both on the
when a suction of −50 to −200 mmHg is applied, right side, where the internal mammary artery
depending on the subatmospheric pressure used, was intact, and on the left side, where it had been
hypoperfusion occurs in the subcutaneous and removed. They concluded that NPWT stimulates
muscle tissue directly adjacent to the wound blood flow in the peristernal thoracic wall after
edge, (1.0–2.6 cm versus 0.5–1.7 cm) while internal mammary artery harvesting.99 Additionally,
hyperperfusion occurs at a distance of 3.0–3.5 cm the research group from Sweden examined the
(subcutaneous tissue) versus the distance of effect of topical negative pressure on the blood
1.5–2.5 cm (muscle) and no changes at all in and fluid content in the sternal bone marrow
baseline levels at a distance of approximately in a porcine sternotomy where the left internal
3.5 cm (muscle) and 4.5 cm (subcutaneous tissue). thoracic artery had been harvested followed by
Thus, the volume of hypoperfusion increases NPWT. Magnetic resonance imaging (T2-STIR
under the influence of higher pressure values measurements) showed that NPWT increases
and is dependent on the tissue, for example the tissue fluid and/or blood content in sternotomy
hypoperfused area measured from the peristernal wound edges and creates a pressure gradient that
wound edge, which expands from 0.5 cm at presumably draws fluid from the surrounding tissue
−50 mmHg to 1.4 cm at −200 mmHg (muscle to the sternal wound edge and into the vacuum
tissue) and from 1.0 cm at −50 mmHg to 2.6 cm source. This ‘endogenous drainage’ may be one
at −200 mmHg (subcutaneous tissue). In muscle possible mechanism through which the treatment
tissue, the area of hypoperfused tissue is much of sternal osteitis is supported by NPWT.100
Further evidence for NPWT effects on tissue and of expression of fibroblast growth factor-2
perfusion in stretched tissues surrounding an (FGF-2) in bone allografts by Western blot analysis
open wound were obtained using direct video they demonstrated that the callus was larger,
microscopy.101 Using alternative surface-probe laser contained more calcium (p<0.05), and expressed
Doppler techniques, others have demonstrated FGF-2 at higher levels (p<0.05) in the NPWT group.
significant increases in relative perfusion in intact Thus NPWT combined with open bone grafting
skin in healthy volunteers.92 An abstract of a promoted bone graft vascularisation.105
preliminary study with the O2C device (perfusions
assessment tool), again on healthy volunteers, Reviewing all studies presented here, it can
also showed some increase in perfusion upon be postulated that NPWT induces a change in
application of a single-use NPWT device.102 It microvascular blood flow that is dependent on
is possible that the establishment of adjacent the pressure applied, the distance from the wound
hypo and hyperperfused tissue zones may be edge, and the tissue type. It may be beneficial to
advantageous in the wound healing process. tailor the level of negative pressure used for NPWT
Increased blood flow may lead to improved according to the wound tissue composition. A
oxygen and nutrient supply to the tissue, as well higher pressure level applied during NPWT has a
as improved penetration of antibiotics and the negative effect on the microcirculatory blood flow
removal of waste products. onto the surface of the wound bed. In soft tissue,
particularly in subcutaneous tissue, it is possible for
The mechanism behind the increase in blood ischaemic states to occur.
flow has not yet been identified, but it has been
speculated that the negative pressure causes a Angiogenesis and the formation
force in the tissue that opens up the capillaries, of granulation tissue
increasing flow. As has been shown both in vitro (in Granulation tissue is the combination of small
processed meat) and in vivo (in human wounds),51,52 vessels and connective tissue that forms in the
blood flow reduction occurs in response to the wound bed. It provides a nutrient-rich matrix that
negative pressure compressing the tissue surface. allows epidermal cells to migrate over the bed of
When tissue perfusion is reduced, angiogenic the wound. Angiogenesis and evidence for such
factors are released to stimulate the formation effects has been described in a diabetic mouse
of new blood vessels. 103
This may promote model, in which the highest concentrations of
granulation tissue formation and wound healing. VEGF were detected in the wound edge during
By using another technique to visualise the treatment of NPWT.24,26,106,107
microcirculation by intravital microscope system
in animal experiments Sano et al. demonstrated Change in bacterial count, bacterial
a significant increase of blood flow at 1 minute clearance and immunological effects
after NPWT application, which was sustained for NPWT offers a closed system for wound healing,
5 minutes—a result which is influenced by the as the adhesive drape provides a barrier against
nitric oxide (NO) synthesis network. 104
In another secondary infection from an external source
recent study Hu et al. investigated the effect and and has been suggested to reduce the bacterial
mechanism of NPWT combined with open bone load in the wound. A reduction of the wound
grafting to promote bone graft vascularisation. infection rate and the degree of bacterial load
Based on X-ray imaging, fluorescent bone labelling, has been described as a secondary endpoint
measurement of calcium content in the callus, in several publications.31,86 There are only two
studies on this subject, Morykwas et al.24 and in the bacterial count will develop for individual
Moues et al., 108
in which the results of NPWT were species. This observation is also confirmed in the
investigated in comparison with conventional retrospective study by Weed et al.110 in which
therapy. In an animal study (5 pigs)24 the degree the bacterial load was analysed before, during
of bacterial clearance in acute artificial wounds and after NPWT. Here, there was an overall trend
after inoculation of Gram-positive cocci (two were towards an increase in the bacterial count, which
inoculated with Staphylococcus aureus and three increased by 43 %, while remaining constant
with Staphylococcus epidermidis)was investigated. in 35 % and decreasing in only 22 % of cases. It
Moues et al. analysed the clearance of a total of 50 must be emphasised that the degree of bacterial
different bacterial species 108
in human wounds of colonisation was unrelated to the success or failure
different ages and origins (n=54). The favourable of NPWT. Wound healing without problems, even
result might thus be assumed at least for acute, in wounds with bacterial contamination, could be
artificially created and infected wounds under observed in all three studies. Wounds with >106
optimal healing conditions. However, another bacteria/gram of tissue healed without problems
paper has found that the bacterial load remains while some wounds did not heal despite a low
high in NPWT foam, and that routine changing bacterial load (<105 bacteria/gram of tissue). Thus,
does not reduce the load.109 the question arises whether the bacterial load that
remains under NPWT (or other procedures) really
However ,the results of Moues et al. appear must always be considered to be a critical element
contradictory. Although they show a reduction for wound healing. It also remains doubtful
in the number of colonies/gram of wound whether more frequent dressing changes would
tissue (as determined with the aid of biopsies), have had a more favourable effect on the degree
the favourable result of the reduction of the of bacterial clearance. On the whole, it appears
bacterial load is limited to Gram-negative likely that acute, purely superficially contaminated
bacteria. Contrary to Morykwas et al., the study wounds (as in the model of the Morykwas
occasionally demonstrates an increase in Gram- study) can be decontaminated more easily by
positive staphylococci in the tissue during the application of NPWT than chronic wounds,
NPWT. Unfortunately, the two patient groups which are also contaminated in the deeper layers.
that were compared in the Moues study are so So, in conclusion it cannot with certainty be
inhomogeneous in terms of age and origin of established whether NPWT reduces bacterial
the wounds that, strictly speaking, no exact load in the wound or not. It is exceedingly
comparison of the two groups is possible from a important to perform proper debridement between
critical point of view. Two to three-fifths of the dressing changes to mechanically remove the
patients in both groups of the Moues study were microorganisms. It is well known that the majority
treated with antibiotics, which could result in of wounds contain bacterial biofilms111 that are
bacterial selection. Also, there is no information difficult to treat if not debrided frequently, as
on the possibly different degrees of contamination they can return to their original status within
in the individual wounds at the beginning of the 48–72 hours of the last debridement.112
treatment and the proportion of acute and chronic
wounds. Nevertheless, this study illustrates that A few other publications provide some insight
NPWT does not always produce a quantitative into the pathophysiology of local and systemic
reduction of the bacterial load in contaminated immunological effects of NPWT. An accumulation
human wounds. It is even possible that an increase of activated T-lymphocytes could be demonstrated
in the NPWT foam.113 This finding could have shown that the exogenous application of the
indicate that the foam should not be regarded previously mentioned cytokines has a favourable
as immunologically inert under therapy; due to effect on wound healing.121–126 It seems possible
the accumulation of immunologically competent that NPWT, which produces a comparatively
cells, immunologically relevant reactions could higher VEGF/platelet derived growth factor (PDGF)
take place at the interface between foam and concentration, creates more favourable wound
tissue. However, the number of granulocytes healing conditions Note: there is a non-linear
in the wound was reduced.114 According to interaction in the complex cytokine network.127–129
Buttenschoen,115 NPWT does not seem to have
a major effect on whole-body inflammation. No The role of proteases was assessed by Succar in
relevant changes could be demonstrated for the 2014130 suggesting that mouse mast cell proteases 4,
parameter interleukin-6, which is considered a 5, and 6 are mediators of the critical role mast cells
highly sensitive marker for inflammatory whole- play in NPWT in the proliferative phase of healing.
body reactions. They could not prove to what
degree the endotoxin values are a marker for a Based on systematic review of the molecular
potential systemic effect of NPWT. Furthermore, mechanism of action of NPWT, Glass et al.
two studies gave no insights into one part of the demonstrated that cytokine and growth factor
cytokine network influenced by NPWT. 116, 117
expression profiles under NPWT suggest the
promotion of wound healing occurs by modulation
Molecular mechanisms in wound healing of cytokines. This leads to an anti-inflammatory
The positive effects of NPWT are attributed to profile and mechanoreceptor and chemoreceptor-
the effects of the vacuum-related mechanical mediated cell signalling, culminating in
stimulus on cell function, protein synthesis and angiogenesis, extracellular matrix remodelling and
gene expression with resulting matrix-molecule deposition of granulation tissue.131
synthesis and cell proliferation.24,108,118 However,
this explanation is given as a mere conclusion by By assessing the localisation and time-course of
analogy to the results of the scientific investigation the cell division control protein 42 (Cdc42) in
of the effects of callus distraction. In fact, there cell membrane at ambient pressure it could be
are hardly any studies that investigate the cellular shown that NPWT may facilitate cell migration to
effects of NPWT. accelerate wound healing.132
Walgenbach, showed a proliferation activity of When investigating the effect of NPWT on the
endothelial cells in the newly formed granulation expression of hypoxia-induced factor 1a (HIF-
tissue after the application of NPWT. 119
When 1a), the authors showed that the expression
analysing wound exudate samples from patients of HIF-1a and amount of VEGF were increased
with neuropathic diabetic foot ulcers, Kopp was able by NPWT. This enhances the differentiated
to show that some growth factor concentrations state of vascular endothelial cells (VECs) and
increase, both during NPWT and under the control construction of nucleated blood cells (NBCs),
treatment (hydrocolloid dressing).120 It should be which are advantageous for vascularisation and
noted that there are no currently available data wound healing.133
suggesting that wounds with a high endogenous
cytokine concentration in the wound exudate It is hypothesised that the NPWT device induces
have more favourable healing. Numerous studies the production of pro-angiogenic factors and
promotes the formation of granulation tissue Cefazolin wound tissue and plasma concentrations
and healing. Jacobs 134
found that wounds treated were measured by liquid chromatography mass
with NPWT showed significant accelerated wound spectrometry (LC-MS/MS). At the time of surgery
closure rates, increased pro-angiogenic growth factor and at each subsequent bandage change, wound
production and improved collagen deposition. beds were swabbed and submitted for aerobic
and anaerobic culture. After initiating cefazolin
First insights into the molecular mechanisms treatment, wound tissue antibiotic concentrations
behind NPWT suggest gene expression changes between treatment groups were not significantly
induced by NPWT. Postoperative gene expression different at any sampling time. Similarly, after
changes were compared between NPWT and initiating cefazolin treatment, plasma cefazolin
control patients showing NPWT induced major concentrations were not significantly different at
changes in gene expression during healing. any sampling time.138
These changes ranged from 10-fold induction
to 27-fold suppression. The genes most induced
were associated with cell proliferation and General points
inflammation, and the most down-regulated There are a number of different treatment
genes were linked to epidermal differentiation. variables. The level of negative pressure, the
NPWT enhances specific inflammatory gene wound filler material (foam or gauze), the
expression at the acute phase associated with presence of wound contact layers, the pressure
epithelial migration and wound healing.135 application mode (continuous, intermittent,
However, its continued use may inhibit epithelial or variable), or instillation of fluid may be
differentiation. 135
NPWT is also associated with chosen according to patient needs, disease,
an up-regulation of basic fibroblast growth factor wound type and shape. The healing process
(bFGF) and extracellular signal-regulated kinase may be influenced by varying these parameters.
(ERK) 1/2 signalling, which may be involved in There is widespread clinical experience, but few
promoting the NPWT-mediated wound clinical controlled trials, to support the idea
healing response.136 that adjusting the variables of treatment may
minimise complications, such as ischemia and
NPWT influences the local expression of pro pain, and optimise outcome. There follows some
inflammatory cytokines in tissue or fluid from of the evidence and thoughts of individualisation
acute infected soft-tissue wounds (full-thickness of treatment that exists to date. The rationale
wounds, rabbits). The authors could demonstrate for each of these modification options is briefly
increased local IL-1b and IL-8 expression in addressed below:
early phase of inflammation, which may trigger
accumulation of neutrophils and thus accelerate • Pressure level/suction strength
bacterial clearance.137
• Vacuum source (storage-battery operated therapy
Effect on topical antibiotic concentrations units, wound drainage systems)
Using a canine experimental model, NPWT
treatment of surgically created wounds does not • Intermittent or continuous modus
statistically impact cefazolin tissue concentrations
when compared with conventional nonadherent • Wound fillers (polyurethane foam, polyvinyl
bandage therapy as Coutin et al. could show.138 alcohol foam, gauze)
• Wound contact layers that the pressure in the tissue is positive and not
negative pressure. In a study of free flaps, a range
• NPWT and dermal replacement of positive pressures from +8 mmHg and +12 mmHg
was detected when NPWT was varied from
• Protection of tissue and organs −50 mmHg to −150 mmHg.147 Kairinos et al., in a
wound model of processed meat, showed that there
• Pain treatment is increased pressure 1 cm into the wound edge tissue
and also clinically in thin grafts under NPWT.51,52
• NPWT and adjunct therapies In experiments a spectrum of pressure values of –6
mmHg to 1−5 mmHg (the latter value at a suction
• Other points. strength of 200 mmHg) were found on the surface of
(ex vivo) bovine muscle and at a depth of 1–3 mm in
Pressure level/suction strength the human muscle.146 Thus, the assumption is that,
There is an accumulation of evidence suggesting at least in some parts of the foam/wound-interface,
the effective range of negative pressure is between the application of NPWT is associated with positive
−50 mmHg and −150 mmHg.139 There is however, pressure values. To date, the effects of different
little information on the optimum level of negative suction strengths on wound healing have been
pressure for clinical use and it has been speculated analysed in several studies.148,149 These researchers
that the level of negative pressure may be adjusted investigated wound healing and new granulation
in a number of circumstances. Pressure distribution tissue formation at −25, −125 and −500 mmHg149 and
into the wound depends on the direct contact at −25, −50, −75 and −150 mmHg.148 The two studies
between the wound filler and the wound tissues. concur that a suction of around −25 mmHg is more
Tissue that is not in contact with the wound filler unfavourable than a suction strength of around
will not be subject to suction force, as seen in a −125 mmHg. There is only one study with wound
sternotomy study.140 A wound contact layer slightly healing outcomes of −500 mmHg and one study
lowers the level of negative pressure that affects the for the comparison of the suction values of −50 to
tissue level.141 −150 mmHg. No significant difference in the wound
area was found between the suction strengths of
According to findings published from an animal −50, −75 and −125 mmHg. Unfortunately, none
study by Morykwas et al., a suction level of of the research groups analysed the suction range
−125 mmHg was suggested for many years as the of −50 to −200 mmHg, which is normally used
optimal suction strength for new tissue formation (commercially available vacuum sources). Pressures
and wound cleansing. However, it was found that as low as −40 mmHg may be used for the treatment
the capacity to vary the suction strength can be of sensitive, poorly perfused tissue. These levels
useful under certain circumstances. For instance, in of negative pressure are shown to provide about
certain cases of patients with pain and with poorly half the maximal blood flow effect in a porcine
perfused deep soft tissue it can be appropriate to peripheral wound study.150 According to the same
choose a suction setting less than −125 mmHg. 142,143
study,150 levels of negative pressure higher than
−80 mmHg are seldom necessary. However, in
Overall, the studies give a reliable indication that another study on porcine peripheral wounds it was
there are positive pressure values at the interface suggested that exudate drainage may be improved at
between foam and wound surface (‘underneath’ −125 mmHg. This pressure could be used for the first
the foam).144–146 Interestingly, it has been shown few days to treat high-output wounds, after which
the negative pressure may be lowered as the amount vascular disease, diabetic foot ulcers (DFUs)
of exudate lessens. 150
and thin skin transplants, or when patient can
experience pain during treatment.93,139,152,154–160
Low pressures may be ineffective, whereas high In these circumstances, a high level of negative
pressures may be painful and have a negative pressure should not be applied because of the risk
effect on the microcirculation. Generally, pressures for ischaemic injury to the tissues.
between −75 and −125 mmHg have been suggested.
The most commonly used pressure is −125 mmHg, In summary, between −75 and −125 mmHg has
is based on 1997 research.25 Experimental studies been suggested, but special considerations have
in pigs have shown that the maximal biological to be taken into account when dealing with the
effects on the wound edges in terms of wound treatment of sensitive, poorly perfused tissue and
contraction,150 regional blood flow150 and the highly exudating wounds.
formation of granulation tissue151 are obtained
at −80 mmHg. A recent case report concurs that Vacuum source
negative pressure levels lower than −125 mmHg Today several NPWT devices are available. They
result in excellent wound healing.152 are battery powered or mechanically driven. All
these devices allow the patient to be mobile and
Based on the observation that higher suction independent from hospital’s wall-suction on the
values generate hypoperfused areas of a larger ward and to be treated by NPWT in the home care
volume and that there are no significant setting. Some battery-powered NPWT units use
differences in wound area reduction between the an electronically controlled feedback system that
suction strengths of −50, −75 and −125 mmHg, it ensures the maintenance of the selected pressure
may be assumed that a reduction of the usually level (for example, −50 to −200 mmHg) even in
selected suction strength from −125 mmHg to less the presence of small air leaks, guaranteeing the
than −100 mmHg is at least not detrimental and effectiveness of NPWT.
protects poorly perfused tissue. This statement is
supported by a porcine study, which hypothesised The electronically controlled feedback system, not
that instead of the highest negative pressure implemented in all mechanical systems, ensures
value, the suitable value for NPWT is the one the maintenance of the selected pressure level
which is the most effective on regulating wound giving the patient higher safety. Additionally,
relative cytokines. Analysing the bacterial mostly audiovisual alarms alert the staff and the
count, histological and immunohistochemical patients to large air leaks (loss of seal), blockage
examination and Western blot testing of the of the tubing and full canisters (content between
expression of VEGF and bFGF showed that 125 ml and 1000 ml). These therapy units are
comparing with vigorous negative pressure, designed to reduce complication and allow faults
relatively moderate pressures contribute to wound to be promptly recognised. If the patient is mobile,
healing via accelerated granulation growth, smaller vacuum sources should be used, which
increased angiogenic factor production and can easily be worn on a strap over the shoulder
improved collagen fibre deposition.153 or around the neck (particularly suitable for
outpatient therapy). Some of the smaller devices
Special attention with regard the pressure level are disposable NPWT devices producing a vacuum
may be made when there is a risk for ischaemia, for between −80 and −125 mmHg. Some of these
example in the case of circumferential dressings, single-use NPWT systems are canisterless and
manage wound fluid through a combination of suction, but only lowering the suction, to 50 %
absorbing materials and highly breathable film for example, should be able to maintain the
within the dressing. highest degree of blood vessel formation and
also a significant decrease in pain compared
Traditional NPWT systems use an electrically with the traditional intermittent group.168 Thus,
powered pump to generate negative pressure at the using variable NPWT in this mode, the patient
wound bed. Developments since 2010 have led to discomfort decreased while maintaining superior
the introduction of portable devices that delivers wound healing effects as the intermittent
NPWT without the use of an electrically powered mode. The therapy applied with intermittent
pump. These smaller light-weight devices are mode produces a mechanical stimulation of
mechanically powered and generate continuous the wound bed (a massaging effect)169 and a
subatmospheric pressure level to the wound bed greater circulatory stimuli,170 oxygenation and
between −75 and −125 mmHg. In comparison angiogenesis, and presumably a lower risk of
with electrically powered NPWT system, the occurrence of ischaemic damage.
mechanically powered systems, in smaller
wounds, showed similar biomechanical properties, It has been suggested that therapy may be applied
functional wound-healing benefits and a in continuous mode for the first 24 hours and
clinically suitable usability for both clinicians and possibly, if you want the effects above, changed
patients.161–167 This technology has demonstrated to the intermittent mode (IM).139 An in vitro
similar efficacy and increased usability for both model of infected wound with no blood flow
clinicians and patients when compared with like necrotic tissue, was used to investigate the
electrically powered NPWT devices. effect of various types of negative pressure on
the proliferation potency of non-pathogenic
Intermittent or continuous modus Escherichia coli. The proliferation potency of
The different equipment also allows determining Escherichia coli was higher under intermittent
the mode of administration of the pressure that negative pressure rather than under continuous
may be applied in a continuous or intermittent negative pressure and higher under intermittent
mode. Negative pressure is most commonly negative pressure with a short cycle than with a
applied in the continuous mode. Intermittent long cycle.171 It should be remembered that, in
mode involves repeatedly switching on and clinical practice, the continuous mode is still the
off (usually 5 minutes on to 2 minutes off), most widely used NPWT option. This is against
while variable NPWT provides a smooth cycling the background of the literature supporting
between two different levels of negative pressure. wound healing using the IM in comparison with
There are experimental indications that NPWT the continuous mode. Thus, there is a disparity
with intermittent suction may be of benefit for between science (valid reasons to use the IM)
wound healing. Morykwas et al., for instance, and the current practice (almost no use of IM).172
showed that new granulation tissue formation Nevertheless, under special wound conditions,
is significantly greater in intermittent suction when the wound involves structures such as the
mode than in continuous suction mode.24 On peritoneum, between toes, in tunnelling injuries,
the other hand, intermittent therapy may result in sternotomies, in the presence of high levels of
in a higher occurrence of pain in the treated exudate and when using NPWT on grafts or skin
patients. However, it should be considered that flaps, the continuous mode is the option
new pressure cycles, without going to 0 mmHg of choice.
Wound fillers with foam than with gauze. Similarly, wound
For NPWT it is necessary to fill the wound with contraction was more pronounced with foam than
a compressible open porous material. For this, with gauze.179,180 Wound fluid retention was lower
there are foams and gauze available with different in foam, while more fluid was retained in the
properties such as pore size and stability. Several wound when using bacteria and fungus-binding
studies have shown that the choice of wound
57
mesh.179 NPWT may be tailored to the individual
filler material has considerable influence on the wound type to optimise the effects and minimise
wound healing process. There are also technical the complications by choosing different wound
considerations during the application of a wound fillers. The choice of filler may be made with regard
filler for NPWT. PVA foam, for NPWT was the first to the morphology of the wound, the wound
used material (since 1988, white foam, pore size characteristics, the patient feedback, possible
60–1500 μm), a slightly firmer and less pliable infection and scar tissue formation.
with low risk of ingrowth. Today, polyurethane
foam is the most widely used type of wound filler, Morphology of the wound
introduced 1997, pore size 400–600 μm, soft, black. There are different types and shapes of wounds.
It forms a fairly strong mechanical bond with the Wounds may be uniform or have irregular beds with
wound tissue after approximately three to four or without the presence of undermining. Foam may
days due to the ingrowth of granulation tissue. fit better into a wound with a uniform shape, while
The foam should be changed after two to three gauze may be easier to apply in wounds that have
days. In 2007, gauze was introduced to the market an irregular shape, or with undermining since it can
as a filler for use with NPWT.173 The gauze has a be better manipulated to the shape of the wounds.
spiral shape and is impregnated with an antiseptic Different wound fillers can also be combined.159 In
substance (0.2 % PHMB). Numerous studies have deep wounds, with or without association with an
shown the wound healing effects of gauze.174–176 area that is undermined, both fillers may be applied
It should be noted that pressure distribution is in order to fill the wound efficiently.139,181 Over a thin
similar for gauze and foam in dry wounds and the graft or a wound sleeve, the gauze also allows us to
differences in performance is rather related to the cover the entire wound in an appropriate manner.
structure of the material and its mechanical effects Negative pressure is only transmitted to the tissues
in the wound, as shown in a porcine study.177 In a that are in immediate contact with the wound
wet wound using gauze a perforated drainage tube filler.140 In complicated wounds with deep pockets,
should be inserted into the wound filler to apply the wound filler must be carefully positioned, and
a good pressure transduction to the wound bed.178 it may be easier to use gauze because it can be
The degrees of micro- and macrodeformation57 of adapted to the shape of the wound.157 Foam may be
the wound bed are similar after NPWT regardless of advantageous for ‘bridging therapy’ since the foam
whether foam or gauze is used as wound filler. compresses to a greater extent than, for example,
gauze and thereby contracts the wound and speeds
The biological effects of NPWT depend on the type up the closure.154,160
of wound filler. Blood flow was found to decrease
0.5 cm laterally from the wound edge and increase Exuding wounds
2.5 cm from the wound edge, but was unaltered In heavily exuding wounds, foam at a higher
5.0 cm from the wound edge. The increase in pressure (−120 mmHg) may be useful, since foam is
blood flow was similar with all wound fillers. The less dense that gauze and a higher level of negative
decrease in blood flow was more pronounced pressure drains the wound quicker.182
Wounds at risk of ischaemia wounds where large amounts of granulation tissue
NPWT should be applied with caution in wounds is desirable, for example, postsurgical wounds
at risk of ischaemia.93,139,154,155,158–160,181 Apart such as sternotomy wounds.
from lowering the level of negative pressure,
the clinician may carefully choose and trim Pain upon NPWT dressing removal has been
the wound filler. Gauze produces slightly less reported and is believed to be associated with
hypoperfusion effects than foam.183 Gauze granulation tissue growth into micropores present
and a large piece of foam produces less wound on the foam,156,187 Wound tissue damage upon
contraction, presumably resulting in less pain, removal of the foam may cause the reported pain.
compared with a small piece of foam. 184
Taken Based on assessing released neuropeptides that
together, in circumstances where there is a risk of cause inflammation and signal pain (calcitonin
ischaemia, a lower pressure (−40 to −80 mmHg) gene-related peptide, substance P), using gauze
and using gauze may be considered. may be one way of reducing NPWT dressing
change-related pain.188
Infected wounds
There are various wound fillers designed for Wound contact layers
infected wounds: foam with silver, gauze In NPWT wound fillers (foam or gauze) are used
that is impregnated with PHMB, gauze that is to ensure that the negative pressure is applied
impregnated with silver. Instillation techniques across the entire wound surface. However, there
allow the irrigation of the wound with antiseptic are reports that foam can cause pain and trauma
solutions.139,185 In these situations hydrophilic at dressing change.156,187 For this reason, when
foams should be used. foam is used as a filler, a liner—for example
bacteria and fungus binding mesh—can also
Bacteria and fungus binding mesh is an alternative be applied as a wound contact layer.189 When
wound filler in NPWT which produces a significant the clinician anticipates complications, a non-
amount of granulation tissue in the wound bed, adherent wound contact layer such as paraffin
more than with gauze and without the problems of or silicon may be placed over the wound bed
ingrowth, as with foam.179,186 beneath the wound filler.190,191 A wound contact
layer also may be placed over vulnerable
Tendency to the formulation of excessive structures such as blood vessels or nerves191
granulation tissue as well as over the wound bed itself because
One of the limits to the use of NPWT is the it is believed to protect against ingrowth of
formation of excessive granulation tissue. This granulation tissue into foam.190
may lead to fibrosis, scar tissue, and contractures,
which are undesirable when the cosmetic or In the clinical setting, the presence of a wound
functional result is important. Biopsies taken of contact layer may reduce the pain during
the scar tissue after treatment with gauze showed dressing changes as has been reported in
a minor tissue thickness and disorganisation and several case studies.190–193 However, studies in an
less sclerotic components. 175
Thus, areas such experimental porcine wound model have shown
as joints, where movement of the skin and the that a wound bed under a non-adherent wound
underlying tissue occur, may benefit from the contact layer is devoid of microdeformation and
use of gauze. 181
Foam allows rapid growth of has less granulation tissue than a wound bed in
granulation tissue and may be a better choice in direct contact with the wound filler.183 The reason
for the difference in effect between a wound filler organs or other sensitive structures in the wound
and a wound contact layer is that the structure of due to the risk for severe complication. In 2003,
the material in the dressing in direct contact with Abu-Omar et al. described two cases of right
the wound bed determines the effects of NPWT ventricular rupture during NPWT of the sternum
on the wound bed.151,183 Therefore, it is important due to mediastinitis following coronary artery
to use wound contact layers only when there are bypass grafting (CABG).206 In 2006, Sartipy et al.
structures to protect, in order not slow healing. 194
reported five additional cases of right ventricular
rupture following NPWT in patients treated for
NPWT and dermal replacement post-CABG mediastinitis, three of which died.207
The use of synthetic dermal replacements (SDRs) The risk of right ventricular rupture and bypass
in the treatment of large wounds, which have graft bleeding following NPWT of mediastinitis
associated morbidity and mortality, has attracted is estimated to be between 4–7 % of all cases
great interest.195,196 For this, NPWT systems can treated.206–216 Severe bleeding of large blood vessels
be used as a securing adjunct to collagen-elastin such as the aorta has also been reported in several
dermal templates to the wound bed. NPWT is patients receiving NPWT.212,215 NPWT has shown
effective for bolstering single-stage collagen-elastin good results in treating postoperative infections in
dermal templates onto wounds.197 Additionally, peripheral vascular grafts,217 but here too, reports
positive results were reported in acute and of bleeding have started to emerge. The incidence
chronic non-healing wounds reconstructed of NPWT-related bleeding in patients with exposed
with a commercially available bilayer, acellular blood vessels or vascular grafts (such as femoral
dermal replacement (ADR) containing a collagen- and femoral-popliteal grafts) in groin wounds were
glycosaminoglycan dermal template and a silicone relevant in some studies.218 Severe bleeding has
outer layer combined with NPWT bolstering also been reported in patients receiving NPWT for
followed by split-thickness skin graft.198–202 burn wounds.219
Treating with dermal replacements, NPWT can be
used to secure the artificial substitutes and in a Reports of deaths and serious complications
second step to support the epithelialisation of the associated with NPWT led to two alerts being
dermal replacements.203 In well-perfused wounds issued by the FDA, in 2009 and 2011,220,221
both steps securing the dermal replacement stating that during a four-year period, NPWT had
and bolstering the skin graft can be performed caused 174 injuries and 12 deaths, nine (75 %)
simultaneously by NPWT. Additionally, NPWT of which, were related to bleeding, in the US
generates a increased endothelial cell migration alone. According to the FDA, bleeding of exposed
resulting in a stimulation of the angiogenic blood vessel grafts during NPWT, due to, for
response. 195
In several cases this combination of example, graft-related infections continues to be
SDR/NPWT and skin graft/NPWT could substitute the most serious adverse event. These disturbing
free flap surgery in single catastrophic situations reports caused the FDA to state that NPWT is
after multiple free flap failure, in major third- contraindicated221 in certain types of wounds:
degree flame burns or due to the patient’s poor those with necrotic tissue with eschar, in non-
general condition.204,205 enteric and unexplored fistulas, where malignancy
is present, in wounds with exposed vasculature,
Protections of tissue and organs anastomotic sites, exposed nerves, exposed organs
Within the choice of the use of NPWT, the and untreated osteomyelitis.
clinician need, to consider the presence of exposed
Despite this NPWT is the only measure a clinician conditions, the type of injury and the degree of
may have to manage a severe infection such as pain. The most painful moment of the NPWT
deep sternal wound infection and off-label use (use may be at the time of dressing change. Foam has
outside the manufacturer’s recommendations, in micropores that enable the growth of granulation
which case the patient should be closely monitored tissue into the dressing,151,238 as tissue is torn
by the responsible physician) has continued as away at the time of dressing change it is more
there are no alternatives that give comparable painful.187,239 However, there is a development in
results. For example, Petzina et al. showed that dressings that address this problem.240
mortality due to mediastinitis was reduced from
25 % to 6 % when using NPWT, compared with In patients that are neuropathic or paraplegic, where
conventional treatment, even with the risk of the pain is not of a significant nature, the filler
right ventricular rupture.222 Good results have can be used more efficiently. In patients with low
also been reported during NPWT of infected adherence, especially children and the elderly, and
vascular grafts.217
As the number of complications on painful lesions (such as pyoderma gangrenosum,
arising from NPWT treatment has increased, the burns, PUs and infected wounds), gauze, which
importance of protecting exposed organs (for not allow ingrowth,238 tends to be better tolerated.
example, blood vessels) has been emphasised in Gauze also facilitates dressing changes and reduces
the international scientific literature.210,223–226
the risk of the wound filler becoming attached to
the tissue and remaining in the wound,151 which is
It has been suggested that exposed sensitive of special importance in wounds with deep pockets
structures need to be protected either through the that are difficult to inspect. Based on the assessment
interposition of autologous tissue (muscle flaps) or of released neuropeptides that cause inflammation
with heterologous material (dermal substitutes) or and signal pain, gauze may be one way of reducing
a number of wound contact layers. A number of NPWT dressing change-related pain,188 which seems
studies have analysed the possibility of applying to be related to the more adhesive nature of the
protective discs over exposed structures. 227–229
foam—probably because of the ingrowth of the
The technique has been proven efficacious in granulation tissue in the micropores present on
protecting the heart227–232 and reducing the the foam.187 It has been shown that foam produces
NPWT effects on large blood vessels.233–235 It is greater wound contraction than gauze.180,184 Another
recommended that patients treated outside the option to reduce pain due to NPWT is to prepare
manufacturer’s recommendations should always be the patient by infiltration of the wound filler with
closely monitored and documented. saline solution or local anaesthetics before dressing
change. Administration of topical lidocaine into
Pain treatment the wound filler has been shown to decrease pain
NPWT is considered an effective wound during dressing changes compared with saline. In
treatment, but there are a number of issues that the study, patients were randomised to receive either
need to be addressed for improvements to be 0.2 % lidocaine or 0.9 % saline administered through
made. Several studies reported varying levels of the NPWT tubing into the foam dressing 30 minutes
pain in patients undergoing NPWT, with certain before changing the dressing.241 Other authors have
treatment factors affecting the level of pain, confirmed these results.242,243
such as the NPWT system and the dressing/
filler used.236,237 Adherence varies from patient NPWT and adjunct therapies
to patient and depends on the underlying NPWT can work in combination with instillation
of certain fluids more effectively. This combination cavity: in order to prevent possible retention of
of NPWTi generates an additional therapeutic wound secretions, it must be completely filled
option. NPWTi is described in more detail in with foam cut to the cavity’s dimensions. A
the section on page 53. Another modification of plastic surgeon should be consulted at the time
the traditional NPWT will be the use on closed of the second look operation in order to plan an
incisions, ciNPT, to prevent surgical site infections. early soft tissue closure
ciNPT is described in more detail on page 56.
• If required, depending on the body part, an
additional immobilisation with an external
Indications in specialties fixator may be performed. The pins of the
Open fracture-induced soft tissue wounds and fixateur can compromise the vacuum seal. In this
the closure of the dermatofasciotomy wound situation the wound filler (foam or gauze) should
were the first reported indications for NPWT.244,245 be extended to include the fixator
NPWT is now used in more and more indications
in orthopaedic surgery, traumatology, plastic and • In cases of incomplete or complete amputations
reconstructive surgery and is a treatment option secondary to trauma in which reimplantation
that is implemented in the daily routine of many is out of question, a definitive repair of the
trauma and orthopaedic departments in Europe. amputation stump is often not possible because
In the following sections the importance of NPWT of the local and general situation of the patient.
will be presented in more detail. Thus, soft tissue debridement as part of damage
control will be necessary
NPWT in acute traumatology and for the
closure of dermatofasciotomy wounds • An amputation stump resulting from a
NPWT is a tool in the treatment of traumatic guillotine-like marginal zone amputation
wounds and high-risk incisions after surgery. remains open and a temporary soft tissue
During the two decades of the use of NPWT, the coverage by means of NPWT can be the
indications have expanded, allowing its use in a procedure of choice
variety of clinical scenarios:246,247
• NPWT may be used on dermatofasciotomy
• Contaminated acute wounds (open fractures, wounds, decreasing dressing change frequency
penetrating injuries, decollement injuries (Morel- and minimising soiling of the patient’s bed, bed
Lavallée syndrome)248,249 and wounds with tissue linen, towels and clothing, even in the case of
defects requiring a step wise procedure followed by heavily exuding wounds
a delayed primary closure or plastic surgery
• After decompressive dermatofasciotomy for
• In cases of heavily contaminated wounds or compartment syndrome, low-level continuous
wounds with big tissue defects, the resection of suction should be used. Particularly, in case of
damaged and potentially infected soft tissue and severe ischaemia, NPWT using a pressure value
the closure of the debrided wounds are often of −50 to −100 mmHg is adequate. The low-level
not feasible and prolonged wound management of negative pressure appears to be sufficient
must be performed to apply tension to the wound edges and to
produce an anti-oedema effect.
• Where attention has to be paid to the wound
In general, NPWT does not replace adequate transplantation can be regarded as a reliable
surgical treatment of soft tissue injuries and option to obtain a good outcomes of wound
should be regarded as a temporary measure healing and satisfactory functional recovery for
before definitive treatment of the defect and the management of motorcycle spoke
for wound conditioning. Besides its useful heel injury255
mechanism of action at the cellular level, the
mechanical drainage principle and reduction of • In clinical situations of traumatised less
dead spaces in the wound defects, are important perfused soft tissue, the suction level for NPWT
factors for reduction of bacterial colonisation should be minimised to −50-75-100 mmHg to
and for prevention of infection in open wounds. prevent a further impairment of the perfusion
Caution is advised when using the method in of the soft tissue.256
acute trauma situations where bleeding might
occur due either to the localisation of the wound • For perineal trauma-related wounds the use
or to an existing systemic coagulation defect. of NPWT led to improvement of local wound
The literature presents 185 peer-reviewed articles conditions faster than traditional dressings,
dealing with injured and traumatised patients. without significant complications, proving
To date, reports in this surgical literature consist to be the best alternative as an adjunct for
mainly of case reports, nevertheless in the special the treatment, always followed by surgical
field of trauma wounds there exist two RCTs.250,251 reconstruction with grafts and flaps250,257
The most important conclusions in the literature
between 2011 and 2015 are: • Beside the use of ultrasound and computed
tomography in the preoperative evaluation
• NPWT is a useful treatment option for of the penetrating trauma patient, the use
open fractures, to bridge between initial of temporary vascular shunts, the use of
debridement and final microsurgical tissue preperitoneal packing in pelvic fractures and
transfer. NPWT significantly reduced modern rehabilitation-management of the
morbidity and healing time of injuries multiple traumatic amputation patient, NPWT
when compared with previously performed is one of the most important innovations in
dressing treatments.252,253 Considering patient operative trauma surgery since 2000.258
comfort, the costs related to the NPWT, and
the final flap results, a 7-day interval between The two RCTs (see table, appendix 3) evaluating
changes of the NPWT is acceptable.252 Other the impact of NPWT after severe open fractures
authors observed no disadvantage if patients on deep infection demonstrate that the relative
underwent NPWT for an average of 12 days risk ratio for infection in the NPWT group is
(range: 1–35) and concluded that traumatic 0.199 [95 % confidence interval(CI): 0.045–0.874],
lower limb reconstruction in the delayed suggesting that patients treated with NPWT
period is no longer associated with high rates were only one-fifth as likely to have an infection
of flap failure. Improvements in microsurgery compared with patients randomised to the
and the advent of NPWT have made timing no control group. NPWT represents a promising
longer crucial in free flap coverage of traumatic new therapy for severe open fractures after
lower limb injuries254 high-energy trauma.251 Additionally, one group
analysing widely applied methods of delayed
• Sequential therapy of NPWT and pedicled flap primary closure of leg fasciotomy (NPWT, shoelace
technique), showed that both NPWT and the of infected endoprostheses (see pages 53–56).
shoelace technique are safe, reliable and effective Periprosthetic infection treated by NPWTi with
methods for closure of leg fasciotomy wounds. antiseptic solution using a reticulated sponge
NPWT requires longer time to definite wound in combination with NPWT was suggested to
closure and is far more expensive than the shoelace be easy and effective to use. With this system,
technique, especially when additional skin grafting early treatment of periprosthetic infection with
is required.250 antiseptic irrigation in combination with NPWT
decreasing the bacterial burden, salvage of
Periprosthetic infections of the hip and prosthesis seems to be possible. Nevertheless, final
knee joint conclusions about this therapy can only be drawn
NPWT is a useful option in the management of after examining a larger series of patients.260 In terms
early or delayed infections following implantation of legal issues and patient safety, treatment outside
of an endoprosthesis (rate approximately 1–2 %). the manufacturer’s recommendations should always
To date, only a few peer-reviewed articles have be closely monitored and documented.
addressed this subject, two case series (evidence
level 4) and two case reports (evidence level 5). The NPWT in the treatment of osteomyelitis
advantages of NPWT for this indication are: and surgical site infection
Wound infections even today occur in up to 50 %
• Large, open wounds can be converted to of patients undergoing surgery for traumatic
hygienic, closed wounds wounds dependent on the grade of soft tissue
injury, amount of contamination and other
• Wound secretion is continuously collected in patient and operation-related factors. Treating
a canister these postoperative wound infections with NPWT
decreases oedema and dead space, theoretically
• Contamination from the environment is reducing the risk of infection. It also prevents
prevented because the wound is sealed. premature walling off of deeper cavities, which can
occur with the use of NPWT on superficial defects.
The patient benefits from the fact that, even NPWT allows for the reduction of the deep cavity
in the case of a heavily draining wound, the defects without delaying wound closure or creating
dressing requires changing only every 2 to more tissue damage.261 A systematic review showed
3 days minimising soiling of the patient’s bed that there is an increasing body of data supporting
and clothing. This increases patients’ comfort, NPWT as an adjunctive modality at all stages of
while reducing nursing demands. Although the treatment for higher-graded open tibia fractures.
current literature does not provide clinicians with There is an association between decreased infection
many reports, it seems that the effects of NPWT rates and NPWT compared with standard gauze
may contribute to maintaining the implant in dressings. Additionally, there is an evidence to
situ, avoiding the exchange of the prosthesis. support NPWT beyond 72 hours without increased
A systematic review demonstrated that the infection rates and to support a reduction in flap
algorithm: debridement – lavage – change of rates. So, after extended NPWT fewer patients
modular prosthesis components and NPWT leads required flaps than grading at the first debridement
to the highest infection eradication rate (92.8 %).259 would have predicted.262 Besides these topical
advantages in the care of infected wounds, NPWT
NPWTi may further facilitate the treatment provides a more rapid and comfortable treatment
opportunity, representing a reliable alternative treatment of wounds of the extremities. The
to conventional wound care methods. 263
Even coverage of these wounds with split-thickness skin
in postoperative joint infections, study results grafts is associated with poor functional results and
confirm the value of the NPWT following surgical therefore not recommended in the majority of cases.
debridement, in combination with resistance- Wound closure and acceptable functional results can
tested antibiotic treatment, as a sufficient therapy usually be achieved with plastic and reconstructive
for these infections. This procedure leads to safe surgical procedures. Nevertheless, there are situations
treatment of the joint infection, combined with in which the problem of exposed structures cannot
good function of the treated joint, good patient be managed using plastic reconstructive surgery.
comfort and a short duration of the therapy. 264
These include impaired blood flow in the extremity,
marked lymphoedema, extension of the injury
In the treatment of osteomyelitis too, the to adjacent soft tissue or donor sites (especially in
advantage of NPWT is that wound secretion, extensive burns) and the risk of contamination. In
usually contaminated by bacteria, is constantly addition, donor site complications can also result
drained from the wound by negative pressure. At in tendon exposure. Soft tissue defects of the limb
the same time extravascular fluid is reduced. The with exposure of tendons and bones in critically ill
basic step in the treatment of osteomyelitis is the patients usually lead to extremity amputation. The
radical surgical debridement and necrectomy of temporary coverage of these types of defects was an
infected tissue. Usually, sequential surgeries are early application of NPWT. When NPWT was still
necessary to achieve quiescence of the infection. in its infancy the application of NPWT was found
Within this treatment protocol, NPWT as a part to encourage the formation of granulation tissue
of the reconstruction algorithm is used between over bradytrophic tissue and even over exposed
two revisions as a temporary wound dressing. A metalwork more rapidly than any other dressing
promising modification of the technique is NPWTi, technique. Case series have shown that infection
in which antiseptic or antibiotic solutions are used control and limb salvage were achieved in all
to instill the surgical site via the drains and foams cases with multiple debridements, topical negative
(see pages 53–56). pressure therapy, and skin grafts. In all patients, the
exposure of tendons and bones was reversible by this
NPWT serves more and more to prevent these strategy without a free flap transfer. The following
infections, by early use to temporarily close trauma conclusions can be made:
wounds after the first debridements and by using
ciNPT (see pages 56–59).265–269 An evidence-based • NPWT is the treatment of choice when plastic
medicine review of military and civilian extremity surgery procedures cannot be used for the
trauma data provide recommendations for the coverage of exposed bone, tendon or metalwork.
varying management strategies to care for combat- Experimental evidence suggests that intermittent
related extremity injuries to decrease infection suction at a pressure level of −50 to −125 mmHg
rates and showed that postinjury antimicrobial should be used for this indication270
therapy, debridement and irrigation and NPWT are
important aspects.266 • NPWT should be considered as a last attempt
to prevent amputation in a situation where
Exposed tendon, bone and hardware plastic surgery procedures cannot be used
Exposed tendon, bone and hardware represent for the coverage of exposed bone, tendon or
a major therapeutic challenge in the surgical metalwork271
• Even bigger soft tissue defects, for example, of burn-wound sepsis. These therapeutic benefits
with tendon exposure (Achilles tendon) there likely result from the ability of NPWT to decrease
was complete healing with secondary wound bacterial proliferation on the wound surface,
healing (or secondary skin grafting). NPWT is an reduce cytokine serum concentrations, and
optional treatment for the complicated wounds prevent damage to internal organs.277
where reconstructive surgery with a skin flap
cannot be performed.272 In patients with hand burn injuries it is necessary
to consider that NPWT exerts a positive pressure
of 6–15 mmHg on the tissue. The pressure
NPWT in the treatment of intensity is directly dependent on the selection
acute burns and scalds of suction between −50 mmHg and −200 mmHg.

This pressure is the reason for the direct anti-
Since 1999 NPWT has been applied in the oedematous effect of NPWT, which indirectly
treatment of burns and scalds. 273,274
After collecting results in enhanced tissue perfusion. A favourable
initial positive experiences some research centres side effect of this external pressure obviates the
compared NPWT with silver sulfadiazine treatment need for constant elevation of the patient’s hand.
(SSD) in burns, showing that early application of Because the foam is stiff under the suction, splint
NPWT can improve the quality of healing. 275
To fixation is not necessarily required. Despite the
date, there are 66 peer-reviewed articles, including positive effects of NPWT applied at −125 mmHg
some based on animal experiments, examining it should be noted that the induced positive
with NPWT in burn injured patients. Clinical pressures may cause tissue ischaemia in a few
results of these reports showed that NPWT in cases. Thus, the pressure should be chosen
the treatment of burn injuries has strong anti- carefully in order that, on the one hand, the anti-
oedematous effects, optimises wound healing, oedematous effect can be established but, on the
reduces the need for secondary surgery and other, that nutritive perfusion is not reduced, even
facilitates care. 54,276
In contrast to those treated in critically perfused tissue.
with NPWT, conventionally treated patients
showed a significant decrease in perfusion as Human studies show that therapy should begin
measured by dynamic IC-View laser-fluorescence within six hours if possible and should be applied
videography. This positive effect is NPWT- continuously for at least 48 hours to reduce the
related, due to a pressure-induced reduction or formation of oedema and thus reduce post-burn
prophylaxis of the connective tissue oedema damages.54,95,278,279 Based on the experience with
and resulting in better wound oxygenation and superficial and deep dermal hand burns and scalds,
quicker wound healing with less complications in NPWT is considered cost-effective, since it reduces
the majority of cases.96 So, one intraindividually treatment time and the requirements on personnel
designed study showed that in NPWT treated involved in the process, and favourably influences
hands, even with large deep burn injuries, the the clinical process.280
clinical results were better in comparison with
the conventional treatment to the contralateral Other author groups demonstrated a benefit of
hand.54 An investigation in animals indicates that using the NPWT system in thermal injuries to
NPWT inhibits the invasion and proliferation of secure the fixation of skin substitutes, such as
Pseudomonas aeruginosa in burn-wounded tissue tissue-engineered skin substitute and split-skin
and decreases early mortality in a murine model grafts. NPWT is a highly reliable and reproducible
method to bolster these skin substitutes.204,205,281,282 their associated high-fluid exudate following burn
Its ability to conform to contours of the body excision and skin grafting has always posed a
and cover large surface areas makes it especially challenge in burn wound care. The ideal dressing
useful in securing a graft. NPWT as a method of should protect the wound from physical damage
bolstering results in decreased repeat grafting and and microorganisms; be comfortable and durable;
minimal graft loss, thus decreasing morbidity allow high humidity at the wound; and be able
compared with conventional bolster dressings. to allow maximal activity for wound healing
The reported overall skin graft take rate was without retarding or inhibiting any stage of the
over 95 % using suction levels between −75 and process. NPWT fulfils all these criteria. Advantages
−120 mmHg. 283
Negative pressure dressing improves conferred include accurate charting of wound
not only graft take in burns patients but can also exudate; reduced frequency of dressing changes;
be considered when wound bed and grafting lower infection rates through prevention of strike-
conditions seem less-than-ideal.284 A multicentre through; and securing and improving the viability
RCT in burn injury showed, based on extensive of skin grafts. These advantages can be used on
wound and scar measurements, highest elasticity challenging locations such as the open abdomen in
in scars treated with the substitute and NPWT, severely injured burn patients and skull burns.291,292
which was significantly better compared with scars
treated with the substitute alone.285
Plastic and reconstructive
Even in the treatment of paediatric patients
surgery
NPWT seems to be successful for fixation of skin
substitutes and split-skin graft (continuous mode The field of plastic and reconstructive surgery
and −125 mmHg). The main advantage of the was the first in which the introduction of NPWT
technique is a higher mobility of these patients provoked a recognisable change of different
compared with conventional fixation methods. therapeutic concepts. NPWT produced a change
The high compliance rate of an often challenging of paradigms within the treatment algorithms.293
group of patients such as children recompenses Therefore, the older improved construct of the
possible higher initial material costs compared traditional reconstructive ladder is updated
with conventional fixation methods.286,287 to reflect the use of NPWT (beside the new
developments of dermal matrices).294,295
It is possible that the effect that compresses the
tissue can also be successfully used for burns on Acute traumas of the lower limbs cause complex
the torso, if appropriate dressings and dressing functional damage for the association of skin
techniques can be adapted. An enhancement to loss with exposed tendons, bones, and/or vessels,
a technique previously described through the use extensive soft tissue and osseous destruction
of long thin strips of NPWT fillers to transmit as well as heavy contamination requiring a
negative pressure, the enhanced total body wrap, multidisciplinary approach. Once bone fixation
aims to provide ideal conditions to promote and vascular repair have been carried out, the
healing in burns. Using NPWT, this technique is surgical treatment for skin damage is usually
simple and straightforward enough to be applied based on early coverage with conventional or
in the majority of tertiary centres around the microsurgical flaps. In these situations NPWT
world 288
and in extensive burns (total body wrap may represent a valid alternative to immediate
concept).289,290 The management of burns with reconstruction in selected cases of acute complex
traumas of the lower limb.154 Primary soft the multilayer-use of two layers of acellular dermal
tissue reconstruction in complex leg injuries is substitutes (interval of approximately one week)
mandatory in order to protect exposed tissues; combined with NPWT and finally skin grafting
however, it may be precluded by the patient’s combined with NPWT again covered a wider area
clinical status or by local wound conditions of exposed tibial bone in a patient who was not
(patients’ critical condition for example poly- a candidate for further free flap surgery after two
traumatised patient to prevent the ‘second hit’, failed microsurgical plastic procedures.204 Although
advanced age, medical comorbidities, heavily NPWT was claimed to be an attractive option for
exuding wounds and questionable viability of wound care, in one RCT NPWT did not appear to
soft tissues, need for several debridements). 296–298
offer a significant improvement over a standard
In these situations NPWT allows a delay of an bolster dressing in healing of the donor site (radial
early complex reconstructive wound closure by forearm free flap) by skin grafting.304 The majority
free or local flaps. This is important particularly of RCTs showed an increase of final skin graft take
if there is no availability of plastic surgery due to rate,305,284,305–307 for example, Petkar et al. showed an
organisational reasons (for example, war casualties average graft take of 87.5 % (range: 70–100 %, SD:
or in a remote area). NPWT improves the wound bed 8.73) to an average of 96.7 % (range: 90–100 %,
preparation296,299 for patients with large defects and SD: 3.55; p<0.001). Additionally, review of all RCTs
the temporary coverage during the delay period of analysing the scar quality showed significantly
7–15 days (9.7±3.1) when performing the two-step higher quality after NPWT fixation of skin grafts or
surgical approach to a delayed reverse sural flap for other skin substitutes (elasticity, epithelialisation,
staged reconstruction. The aim is to use the distally two-point discrimination).285,305,307 NPWT appears
based neurofasciocutaneous sural flap to increase the as a safe and effective adjunct to delayed soft
reliability of large sural neurofasciocutaneous flaps.300 tissue reconstruction in high-risk patients with
severe lower extremity injuries, minimising
Similar to burn injured patients, NPWT is a valid reconstructive requirements and therefore
tool for reliable fixation of skin substitutes, such postoperative morbidity.298
as tissue-engineered skin substitute and split-
skin grafts in all severe traumatised wounds and
is associated with improved graft survival as Abdominal surgery
measured by a reduction in the number of repeated The management of open abdomen in severely
grafts and graft failure complications in adults204,301 injured patients or those with serious intra-
and in children.302 Thus, in large wounds resulting abdominal infections represents a significant
from severe injuries NPWT significantly increases challenge to the surgeon and may include treatment
the tissue-engineered skin substitute take rate of abdominal compartment syndrome (ACS), effects
to 98±2 % in the fibrin/NPWT group (p<0.003) on respiration, cardiovascular and renal function,
compared with the standard fixation and decrease and even ‘damage control’ laparotomy.308–310
the mean period from Integra coverage to skin The life-sustaining emergency operations in
transplantation to only 10±1 days (p<0.002). patients with severe abdominal injuries are often
Therefore, it is suggested that a tissue-engineered accompanied by visceral oedema, retroperitoneal
skin substitute be used in combination with fibrin haematoma or packing of the abdominal cavity.
glue and NPWT to improve clinical outcomes, The same applies to re-laparotomies carried out to
shorten hospital stays, with decreased risks of assess intestinal viability or to control secondary
accompanying complications.303 In a single case bleeding after damage-control laparotomies, or in
connection with intra-abdominal infections.311–313 n=2307 patients treated in the literature of the last
The pressure of forced abdominal wall closure or 5 years), mostly case series or case reports, reviews
an abdominal infection may lead to ischaemia and as well some experimental animal studies, assessing
necrosis of the abdominal fascia. The latter results in the microcirculation of bowel wall during NPWT.
abdominal rupture with subsequent development of The great majority of all articles are of evidence-
an abdominal wall hernia. 314
level 4 or 5 according to the Oxford classification.
Only three paper include a randomised comparison
Laparotomies within the scope of ‘damage control’ with conventional techniques (evidence level 2b).
with packing, the occurrence of ACS or severe
septic intra-abdominal complications require A recent review underlines the role of NPWT today.
repeated revisions of the abdominal cavity. All these For this study, electronic databases were searched
situations result in an open abdomen which does to find studies describing the open abdomen in
not permit primary closure of the fascia and requires patients of whom 50 % or more had peritonitis
temporary abdominal closure (TAC). TAC should of a non-traumatic origin. The literature search
prevent contamination of the abdominal cavity, identified 74 studies describing 78 patient series,
desiccation of intestine and protect the abdominal comprising 4,358 patients of which 3,461 (79 %)
organs from evisceration and mechanical injury. had peritonitis. The overall quality of the included
Currently used TAC techniques include: 311,315–318
studies was low and the indications for open
abdominal management differed considerably.
• NPWT NPWT was the most frequently described TAC
technique (38 of 78 studies). The highest weighted
• NPWT in combination with an abdominal re- fascial closure rate was found in a reports
approximation anchor system (ABRA) or other describing NPWT with continuous mesh or suture
dynamic suture systems mediated fascial traction (6 studies, 463 patients.
Furthermore, the best results in terms of risk of
• Wittmann patch enteroatmospheric fistula were shown for NPWT
with continuous fascial traction. Nevertheless,
• Bogota bag (a sterile three litre urine bag the overall quality of the available evidence
positioned on the viscera covered with damp was poor, and uniform high evidence-based
abdominal pad and drape) recommendations cannot be made.319
• Absorbable or non-absorbable mesh Only three randomised studies were found and
considered for review. The main information in
• Net + zipper. these studies was:
NPWT has become increasingly established as an • NPWT methods allow the possibility of draining
additional therapy option in the management and accounting for fluids collecting in the
of open abdomen. It meets all requirements for peritoneal cavity320
TAC with a very low complication rate. NPWT of
the open abdomen is carried out using a system • NPWT may offer a solution to fascial closure
specially designed for this indication—abdominal problems and helps prevent peritoneal
dressing system. A review of the literature reveals contamination320
122 peer-reviewed articles (2001–2015, over
• It is suggested that NPWT has advantages self-adhesive connecting pad is positioned over
when compared with the Bogota bag as a it. The latter is connected with the container and
temporary closure method in the management the NPWT device. The vacuum source is normally
of abdominal compartment syndrome. Decrease adjusted to −100 to −150 mmHg,323,324,345 but may
in incision width after ACS laparotomy was go up to −175 mmHg,341,346 and started. Other
significantly faster in the NPWT group than authors found a negative pressure of −75 mmHg
in the Bogota bag group (fascia closure was satisfactory for continual removal of wound fluid
considered appropriate in 16.9 days compared and sufficient for approximating the wound edges.
with 20.5 days, respectively)321 This technique prevents adherence of the viscera to
the peritoneum and allows the abdominal wall to
• Intra-abdominal hypertension prevention is one glide over the bowel loops. At the same time, TAC
factor undoubtedly favouring NPWT methods removal at repeated laparotomies is simple because
against non-NPWT ones for open abdomen (OA) no adhesions form.
management in septic peritonitis 320
A nationwide prospective observational study

• Primary closure rates between groups (NPWT of 578 patients treated with an open abdomen
alone (control) or a study group using NPWT (70 % abdominal sepsis) in 105 hospitals in the
plus NPWT-ABRA) were not statistically different, UK (2010–2011, 18 months) support the generally
where as the number of trips to the operating announced importance of abdominal NPWT. In
room and operating room time use were different. this study the majority of patients (61.4 %) were
Despite higher Acute Physiology and Chronic treated with NPWT. Intestinal fistulation [relative
Health Evaluation II scores, larger starting wound risk (RR)=0.83, 95 %CI: 0.44–1.58], death [RR: 0.87,
size, and higher rates of ACS, closure rates in the 95 % CI: 0.64–1.20], bleeding [RR: 0.74, 95 % CI:
NPWT-ABRA group were similar to NPWT alone.318 0.45–1.23], and intestinal failure [RR: 1.00, 95 %
CI: 0.64–1.57] were no more common in patients
In the sum of all published experiences NPWT receiving NPWT.347
as a TAC option has gained in importance over
the last ten years.5,322–344 A recent technique of The following clinical and experimental
abdominal NPWT differs from the customary experiences with NPWT were published:
NPWT of wounds because of the application of
perforated thin polyethylene film positioned Enterocutaneous fistula
between the viscera and the anterior peritoneal No study revealed any correlation between the
wall. A strategy is to use perforated film equipped occurrences of fistulas before, during, and after
with a fixed thin foam in the middle, which, under NPWT, with diverticulitis being the only risk factor.348
the negative pressure, adheres to the superposed The rate of enterocutaneous (ECF) development was
foam layers, preventing any shift of the film in the between 3.5 % and almost 20 %.349–352
abdomen. Perforations in the film allow wound
secretion flow along the pressure gradient from Direct fascial closure
the abdominal cavity into the receiving vessel of Fascial closure is an additional and particular
the NPWT device. The foam in lenticular form challenge in patients with an open abdomen.
is positioned over the above mentioned film NPWT provides constant medial pressure on
in two layers and the system is sealed with an the fascial edges and this prevents them from
adhesive drape. A hole is cut in the centre and a thinning out or retracting over time. This also
facilitates mobilisation of the fasciae and promotes the probability of delayed primary fascial closure.
subsequent definitive abdominal wall closure. NPWT and mesh-mediated fascial traction resulted
The negative pressure reported in the literature is in a higher fascial closure rate and lower planned
non-uniform at −75 up to −150 mmHg. All reports hernia rate than methods that did not provide
recommend use of continuous suction mode. fascial traction.352
Direct or primary fascial closure is possible in
30–89 %.349,353,354 Type and severity of the various Length of hospital and intensive care
early and late consequences in the treatment of unit stay
an open abdomen are substantially determined Comparing NPWT results with the control
by the complication-inducing causes and the group (mesh-foil laparostomy without negative
basic disease as well as by the options of an pressure) resulted in a significant shorter
efficient in some cases, temporary closure of intensive care unit (ICU) and hospital stay.351
the abdominal wall. Procedures with highest
fascial closure rate have lowest mortality.355 Mortality
Regardless of the underlying pathology (patients The number of deaths during hospitalisation in the
with peritonitis, trauma, ACS or abdominal wall group treated with NPWT was lower than in the
dehiscence), high fascial closure rates of 89 % can group treated with standard methods.361 Procedures
be achieved using a combination of NPWT and with the highest fascial closure rate have lowest
mesh-mediated fascial traction (mesh placement mortality.355 The mortality of patients with an
at the fascial level).317,356 enterocutaneous fistula was 17–30 %. Generally, in
NPWT groups, a significant decrease in mortality
The use of the additional narrowing technique to was seen, with no statistically significant findings
apply NPWT may explain the high closure rates in stratification with c-reactive protien (CRP) and
observed in the patient population of this study. body mass index (BMI). Intraabdominal NPWT
Thus, using a NPWT system, secondary closure offers patients lower morbidity and mortality.362
of the fascia was obtained in 92 %.350,357
An ABRA
combined with the NPWT dressing could be used Other aspects
separately or in conjunction with each other for • It has been suggested, although outside the
closure of delayed open abdomen successfully.358,359 manufacturers recommendations, that it is
Generally, patients with septic complications possible to use the foam dressing intraperitoneally
achieved a lower rate of fascial closure than non- without a fenestrated polyurethane layer without
septic patients but NPWT with dynamic closure an increased rate of fistulas.349
remained the best option to achieve fascial closure.317
The direct comparison with the Bogota bag therapy • NPWT is a reliable tool for infants and children
showed that the number of operations required in with an open abdomen363
the Bogota bag group was significant higher than
in the NPWT group (mortality and complication • NPWTi is suitable for treatment of an infected
rate significantly lower). The mean time for fascial open abdomen following pancreatic surgery.
closure was significantly (three times) longer in the NPWTi in one case report had encouraging
Bogota bag group, compared with NPWT.360 results and seems suitable to be used as an
adjunctive treatment in the management of
Hernia development the infected open abdomen when traditional
The indication for open abdomen contributed to therapy fails to control the infection364
• In animal experiments using laser Doppler surgical wound, while the deep sternal infections (or
velocimetry the microvascular blood flow in post-sternotomy mediation) require at least one of
the intestinal wall was assessed in pigs where the following criteria: a microorganism isolated from
the open abdomen was treated by a temporary the culture fluid or tissue mediastinum; evidence
abdominal closure dressing and the traditional of mediastinitis during surgically exploration; or
NPWT dressing. Intestinal wall blood flow chest pain, sternal instability, or fever >38 °C, in
significantly reduced to 64.6±6.7 % (p<0.05) after combination with purulent drainage from the
the application of −50 mmHg using the NPWT mediastinum or isolation of an microorganism.
dressing, and to 65.3±9.6 % (p<0.05) after the
application of −50 mmHg using a temporary Conventional therapy of these infections was
abdominal closure dressing. The blood flow was debridement of the wound, open drainage,
significantly reduced to 39.6±6.7% (p<0.05) after dressings, broad-spectrum antibiotics, and later
the application of −125mmHg using NPWT and reconstructions with the use of flaps, with a
to 40.5±6.2% (p<0.05) after the application of strip of greater omentum or muscle flaps and
−125 mmHg using the temporary abdominal myocutaneous (unilateral and bilateral pectoralis
closure dressing. No significant difference in major, rectus abdominis, latissimus dorsi). The
reduction in blood flow could be observed mortality rate of patients with mediastinitis
between the two groups. 365
is more than 34 % higher23,35,113,131,366,370 than
that of patients after cardiac surgery without
To summarise, the use of NPWT in patients DSWI (mortality rate 1 –5 %). Furthermore,
requiring open abdomen treatment is reasonable postoperative mediastinitis is associated with high
due to the positive results with respect to morbidity,371,372 decreased long-term survival,373, 374
survival rates and the decrease in the number of prolonged length of hospital stay375 and increased
gastrointestinal fistulae. A significant faster and costs of care.376
higher rate of closure of the abdominal wall was
seen. NPWT requires less number of operations, In recent years, a less invasive approach has
and is associated with a lower complication rate. developed using NPWT. As a result of the excellent
Thus, NPWT offers patients lower morbidity and clinical outcome, NPWT is nowadays the method
mortality and should be defined as a treatment of of choice for poststernotomy mediastinitis.86,223,377
choice in patients with open abdomen. The use of NPWT has reduced mortality to around
5 %, reducing the number and the complexity of
treatments and re-operations.132,378 It shall be noted
Cardiovascular surgery that sternum is not an indication for NPWT due
The infection of the sternotomy is one of the to underlying exposed structures that may rupture
most feared complications of open cardiothoracic and bleed. The treatment is off-label use and is
surgery and has a reported incidence that varies performed on the clinician’s responsibility.
between 1 % and 5 %.23,35,86,87,366 Preoperative risk
factors include age, obesity and diabetes, and intra- NPWT on closed cardiothoracic incisions is a
operative techniques, such as the use of internal novel entity with promising results.379 NPWT
thoracic arteries for the grafts.367–369 There is a over closed incisions to reduce the incidence of
distinction between superficial and deep sternal deep sternal wound infection was first proposed
wound infections (DSWIs). Superficial sternal by Atkins et al.380 who also investigated perfusion
infections include the skin and subcutaneous in order to examine potential mechanisms.381
Traditional devices were used in which thin strips of manufacturers recommendations for using NPWT.
silver-impregnated polyurethane foam were applied However, more and more NPWT has been reported
at −125 mmHg, and in 57 high-risk cases there were to be useful in the treatment of deep perivascular
no incidence of infection.380 In a different study, groin infections (Szilagyi grade II and III, exposed
a small case series of ten high-risk patients was vessel or graft). Evidence for the benefit of NPWT
reported using a single-use NPWT device, again with in the management of other infected wounds has
no incidences of infection.382 In a recent randomised been amply documented since the 1990’s.24,89,388–394
clinical study of standard care versus NPWT on To date, the results of 263 patients have been
closed cardiothoracic incisions was examined in 150 reported in 19 articles (evidence level 2a–5),
high-risk patients (high age, high BMI and diabetes), including one systematic review.
the overall rate of sternal wound infection was
reduced significantly, from 16 % to 4 % after five to There are two studies available characterised by
six days of prophylactic NPWT.383 higher evidence levels comparing the results
of NPWT with those of conventional measures
(evidence level 2b and 3; total 19 NPWT patients,
Vascular surgery comparison treatment: alginate dressing).395,396 In
NPWT of infected blood vessels and these studies the NPWT group had significantly
vascular grafts fewer dressing changes compared with the
Infections affecting vessels and vascular grafts alginate group (p<0.001).395 The time to full skin
are feared complications and pose an enormous epithelialisation was significantly shorter in the
challenge in vascular surgery. Infections can be limb NPWT group (median, 57 days) compared with the
and life-threatening due to uncontrollable arrosion alginate group (median, 104 days; p=0.026). The
bleeding. The incidence of deep wound infections is authors concluded that this finding does not allow
approximately 0.6–8 %, affecting the groin in two- further inclusion of patients from an ethical point of
thirds of the cases. Overall mortality ranges from view, therefore the study was stopped prematurely.396
10–30 %, with 30–70 % seen in connection with
infected aortic grafts. Infection-related amputations The main statements in the published literature are:
are required in 20–40 %. Infections can cause
bleeding, systemic sepsis, septic peripheral emboli • For high-risk surgical patients with a fully
as well as ischaemia of an extremity, or threaten the exposed infected prosthetic vascular graft,
life of the patient. The classical management of an NPWT along with aggressive debridement and
infected infra-inguinal graft consists of explantation antibiotic therapy may be an effective alternative
of the graft and autologous reconstruction or, if not to current management strategies392,397,398
feasible, revascularisation by tunnelling an extra-
anatomic graft through non-infected tissue followed • To create the therapy concept, every infection
by local debridement and wound drainage. In case after vascular procedure has to be individually
in which the vessels can be salvaged, the wound is evaluated
lightly packed with moist gauze for local control.
Usually the graft and defect must be covered with a • Applying PVA foam directly to an exposed vessel
muscular flap.385–387 or reconstruction is possible. Sometimes in a
two-layer combination PVA foam is combined
Previously, exposed vessels, grafts or patches are with polyurethane foam. Today, mostly PU foam
considered to be contraindications and outside is used over a small silicone dressing, a wound
contact layer, which protects the infected vessel • Preventive use ciNPT significantly decreased
or graft the incidence of groin wound infection in
patients after vascular surgery.403
• Low suction does not harm blood vessels or
grafts. Mostly lower pressure levels of −50 to To recap, NPWT in patients with deep peri-
−100 mmHg are recommended to avoid bleeding vascular groin Szilagyi II and III infections can
and further damage of the affected vessel399 be regarded as the dominant strategy due to
improved clinical outcome with equal cost and
• Suction should be used in continuous mode quality-of-life (QoL) measures.395 Even in the
rather than intermittently presence of synthetic vascular graft material,
NPWT can greatly simplify challenging wound-
• If possible, early coverage with muscle, for example healing problems leading to wound dehiscence
sartorius myoplasty, is advantageous (exposed and its sequelae.401 NPWT without muscle flap
grafts cannot be covered with split-skin graft) coverage is considered to be safe within expert
opinion and enables graft preservation in the
• Graft/patch salvage and complete wound healing majority of patients with minimal morbidity,
was achieved in 82–91 % cases399–401 no perioperative limb loss, or mortality.
However, it should be mentioned that NPWT on
• The mean duration of NPWT was 14–43 days399–402 vessels and grafts is outside the manufacturer’s
recommendations. The majority of infected
• The mean duration to achieve complete wound grafts were preserved without reinfection
healing ranged from 24 (a study with sartorius during a mean long-term follow-up of seven
myoplasty) to 51 days 218 years.400,404 This treatment algorithm avoids major
reconstructive surgery and should be used when
• Not evidence-based or literature-based, but dealing with Szilagyi III vascular infections.400
very often discussed: graft infections without For several authors, exclusion criteria for NPWT
involvement of the proximal and distal were an alloplastic graft infection with proximal
anastomosis, the preservation of the graft may be expansion above the inguinal ligament, blood
attempted by NPWT, provided a contamination culture positive for septicaemia or septic
of the graft with pseudomonas is excluded anastomotic herald or overt bleeding.401
• Major complications of NPWT, such as severe Lymphocutaneous fistulas

bleeding, were not reported in studies when NPWT can be used for the management of
using NPWT with lower suction level. Regarding lymphocutaneous fistulae. The successful
pain there are conflicting findings. Some authors treatment of about 20 patients with
reported significantly less pain395 and others lymphocutaneous fistulae of the groin has been
observed an increased need for analgesics in 1/7 of reported in the peer-reviewed literature, as of end
the patients 401
2015, four case reports (level 5 evidence) and 2 case
series (level 4 evidence, one review).405–410
• To prevent severe bleeding complications, when
using NPWT directly in contact with the highly Axillary and inguinal lymph node dissections as
friable infected vessel walls or anastomoses, the well as surgery of the infra-inguinal vessels can
patient should be treated only in the hospital cause injury to efferent lymphatic vessels. This
can lead to lymphostasis or a lymphocele when cancer and postoperative lymphocutaneous fistula.
the skin is intact or to a lymphatic fistula when Of these eight patients, four were treated by NPWT.
a wound is present. A wide variety of therapeutic Their data show that, despite higher primary
options have been developed in the past and introduction costs, NPWT is advisable and resulted
range from the use of compression dressings to in a shortened hospitalisation and reduced overall
scab formation, the use of fibrin glue and, where costs per patient.
possible, ligation of leaking lymphatic channels.
NPWT is described here as a further non-invasive In a paper from Hamed et al. a duration of NPWT
method of treating lymphocutaneous fistulas. of 10–18 days up to closure of the fistula was
reported. A successful wound healing was achieved
To date, the use of NPWT for the treatment of in all patients with no recurrence after NPWT.405
lymphocutaneous fistulae has been reported in
only 19 cases (level 4 and 5 evidence).405–410 The Lymphocutaneous fistulae are rare complications
first report by Greer et al.
406
describes the treatment of general and vascular surgery as well as of
of a 49-year-old female patient with bilateral interventional radiology. They can, however,
lymphocutaneous fistulae after aortobifemoral significantly lengthen hospital stays. The wide
bypass and the treatment of a 77-year-old female variety of treatment methods devised to date
patient who developed a fistula after evacuation of indicates that no one single method has been
haematoma following femoral puncture. In both successfully used in a large enough number of
cases, it was possible to close the fistulae using cases. For this reason, NPWT is described here as an
NPWT alone. Unfortunately, the research group interesting alternative to other treatment options
provides no information on the level of negative for this indication. Moreover, it appears necessary
pressure and the type of suction that was used. to consider and discuss the special level of NPWT
and mode of suction that should be used in the
Steenvoorde et al. report a patient who underwent management of lymphocutaneous fistulae. One of
an ilioinguinal node dissection for a regional the advantages of NPWT is that it is a non-invasive
metastases melanoma.410 Unfortunately, a deep method that can be used outside the operating
wound infection occurred with extensive skin theatre and can also be combined with surgical
necrosis and production of abundant wound procedures such as the attempted ligation of
fluid (750 ml daily). Despite dressing changes six lymphatic vessels or scab formation. Greer et al.406
times daily, the wound deteriorated, necessitating believe that granulation tissue grows as a result
further operative debridement. In theatre, the of NPWT and covers open lymph channels until
authors failed to identify the lymphatic fistula the fistula is eventually closed. The key to success
and therefore were unable to close it. Therefore seems to be the tissue compression caused by
NPWT was started. After 11 days of NPWT, the NPWT. At first glance, this appears to be illogical
lymphatic leakage completely stopped. Concurrent since the application of suction can be expected
successful management of the wound with split- to drain lymphatic vessels and thus to stimulate
skin graft therapy led to a complete closure of the lymph flow. However, findings show that the
wound. The treatment was not painful, dressing foam is actually sucked into the tissue. This causes
changes could be done in the ward, and there were compression of the tissue at the pore walls and low
no complications. The third group, Rau et al.409 suction in the area of the pores. It should also be
retrospectively investigated clinical and diagnostic borne in mind that the suction-induced reduction
data from eight patients (1995–2005) with penile of foam size results in tension on the wound edges,
meaning that the tissue is further re-approximated peripheral oedema due to venous stasis has
and in a compression of the wound. These been evaluated as the major component of ulcer
reflections suggest that a high level of negative formation, and the most important aspect of
pressure should be used in order to apply high the treatment are aimed in contrasting this.415,416
local pressure to the tissue. Since a hyperaemic Compression bandaging and local dressing are the
response with hyperperfusion and the reopening cornerstones of therapy for VLUs.417–419
of closed vessels is not desired in the treatment of
lymphocutaneous fistulas, intermittent treatment LUs have a high tendency to recur, which is why
should not be used. Therefore, from the theoretical it might be helpful to focus on the underlying
point of view, a continuous negative pressure of aetiological factors and the ulcerative and non-
−200 mmHg should be recommended. ulcerative phases, rather than on the treatment of
the single incident.412
NPWT can be used for the treatment of
lymphocutaneous fistulae. The results of The probability of healing is inversely related
experiments support the assumption that to both size and duration of LUs. Ulcers smaller
the compressive effect of NPWT is the key to than 10 cm2 and that have existed for less than
successful treatment. Within expert opinion, a 12 months when first reported to a doctor have a
high continuous negative pressure of −200 mmHg 29 % risk of not healing by the 24th week of care,
appears to be effective for this indication. while ulcers that exceed 10 cm2 and have existed
for longer than 12 months before being reported
have a 78 % chance of not healing by 24 weeks.420
Non-healing wounds
Since the 1990’s NPWT was applied to a number NPWT in leg ulcers
of chronic ulcerative conditions, including LUs, As well as for almost all the others types of chronic
PUs and DFUs, and its adoption has increased wounds LUs were very quickly and intensively
constantly up to now. 27,370,411
For non-healing treated with negative pressure. The benefit that
wounds, the mechanisms of action are removing it could bring to a condition in which the main
fluid and exudates from the wound, relieving aetiological component was high interstitial
pressure, promoting perfusion and, at least pressure due to chronic oedema was immediately
until a certain extent, redistributing pressure in evident to most specialists in this field.163
the wound bed. In the following sections the
indications of NPWT for non-healing wounds will Despite its popularity and the number of papers
be presented in detail. published in the last years on the use of NPWT
in LUs, little evidence has been produced. In a
Leg ulcers recent Cochrane review421 only one RCT satisfied
LUs are open lesion of the lower leg due to arterial the inclusion criteria among the 107 published
or venous insufficiency, or both, that can last articles selected.422
months or even years. They affect as many as 5 %
of the general population and cost more than The RCT analysed included 60 patients randomised
€2,000 per year per patient treated.412–414 While to NPWT or standard dressings and compression
the pathophysiology of arterial ulcers has been up to 100 % granulation on the wounds. Following
linked to the distal ischaemia, the relation to which, both groups received a skin-graft transplant,
vein insufficiency is not completely understood; and those treated with NPWT had further 4 days of
negative pressure, while the others received only of shear and pressure from pressure points, the
standard treatment. mobilisation of patients and the debridement of
necrotic and non-viable tissue, plus local dressings,
There was low-quality evidence of a difference in associated with systemic interventions, such as
time to healing that favoured the NPWT group. antibiotic therapy in case of infection or dietary
The study reported an adjusted hazard ratio (HR) supplementation in case of malnutrition.430
3.2, 95% CI: 1.7–6.2. The follow-up period of the
study was a minimum of 12 months. There was no NPWT in pressure ulcers
evidence of a difference in the total number of ulcers Despite its increasing diffusion among specialists,
healed (29/30 in each group) over the follow-up the use of NPWT in PUs is not yet supported by
period. This finding was also low-quality evidence. sufficient evidence. A recent Cochrane review
There was low-quality evidence of a difference in demonstrated how little high-level evidence is
time to wound preparation for surgery that favoured published in this field.13 This review included
NPWT [HR 2.4, 95 % CI 1.2–4.7]. Limited data on four studies selected from 82 records screened,
adverse events were collected, providing low-quality and showed no differences between NPWT and
evidence of no difference in pain scores and Euroqol traditional therapies for PUs. Furthermore, it did
(EQ-5D) scores eight weeks after surgery. not provide any conclusive data on the possible
advantages of such an approach in this field.431–434
Due to the poor quality of the results the authors
of the Cochrane review concluded that: Moreover, the quality of the study designs, the
small amount of patients included and the possible
‘There is limited rigorous RCT evidence available biases identified by the Cochrane analysis would
concerning the clinical effectiveness of NPWT in the diminish any potential findings. For these reasons
treatment of leg ulcers’ 421 the authors of the review concluded that
Pressure ulcers ‘This comprehensive review of current randomised

PUs affect between 5 % and 10 % of hospitalised controlled trial evidence has highlighted the current
patients and are responsible for a significant uncertainty regarding the effectiveness of negative
decrease of the quality of life, increasing costs pressure wound therapy (NPWT) as a treatment for
of treatment and delayed healing in the affected pressure ulcers’.13
patients. 423–425
A PU is produced by shear stress,
pressure or both over bony prominences and Despite of this, NPWT is increasingly being used
primarily affect insensitive patients, bedridden or to manage PUs, most likely due to its flexibility,
those forced to be immobile. PUs are facilitated by which allows the caregivers to insert it into
malnutrition, chronic diseases, old age and acute a more complex and articulated therapeutic
or chronic reduction in skin perfusion.426–429 strategy. It is expected, for the near future, that
better designed and dimensioned prospective
According to the European Pressure Ulcers trials will improve the evidence profile of NPWT
Advisory Panel (EPUAP), PUs can be classified as for treatment of PUs.
grade I to IV— grade I being the least and grade IV
the most severe.430 Diabetic foot ulcer
With a prevalence ranging between 5 and 10 %
The management of PUs consists of the relieving the of general population, diabetes mellitus is the
most common chronic disease globally, and its the wound from exposure to the environment,
prevalence is expected to increase up to fivefold in reducing odour and helping debridement.
the next years.435,436
The use of NPWT in DFUs has a large span, from
The complications of diabetes—both postsurgical lesions where NPWT is applied to
microvascular, like retinopathy, nephropathy and facilitate wound closure by secondary intention to
neuropathy, and macrovascular, like peripheral non-healing neuropathic or neuro-ischaemic ulcers.
arterial disease and cardiomyopathy—can develop In both cases possible ischaemia and infection must
into clinical syndromes. Of these syndromes, DFUs be addressed before applying NPWT.
represent the most important one, both in terms
of prevalence, since they affect 15–20 % of diabetic However, the evidence for the effectiveness of
patients at least once in their life,437 and in terms of NPWT in DFUs is sparse, as demonstrated in
severity, because they are the most frequent cause a recent Cochrane review.14 From 477 articles
of lower limb amputations and are associated with screened, 20 were evaluated for eligibility, and 5
a mortality that is higher than that of many types met the inclusion criteria.
of cancer.438,439
Of the five RCTs included in the analysis, three
Diabetic foot ulceration is defined as a wound collected data for less than 100 patients, and their
that extends through the full thickness of the skin results were evaluated as inconclusive based on the
below the level of the ankle.440 data given by the remaining two RCTs.446–448 Hence,
the review is based on two well-dimensioned RCTs.
The multifactorial pathogenesis, due to the Armstrong et al. compared NPWT with moist
contemporary presence of neuropathy and dressings in postsurgical DFUs,9 while Blume et al.
vasculopathy complicated by infection, explains compared NPWT with a variety of dressings in the
the difficulties in management of DFUs. It also management of non-healing DFUs.10
explains the tendency of recurrences, which
differentiate DFUs from the other types of chronic Armstrong et al. included 162 consecutive diabetic
ulceration. It has been estimated that only one patients with postsurgical foot wounds due to
third of neuropathic DFU, adequately treated, heal forefoot amputations, which were randomised to
in 20 weeks, and that up to 70 % recur in 5-year NPWT versus moist dressings and followed for 16
follow-up time.441,442 weeks; both healing rates, healing time and number
of amputations were evaluated as outcomes of this
The treatment of DFUs is complex and aims to trial. There was a statistically significant increase
address all the relevant components that generate in the number of wounds healed in the group
and sustain the non-healing wound.440,443 Offloading, treated with NPWT (43/77; 56.0 %) compared with
debridement, revascularisation, systemic antibiotic the moist dressing group (33/85; 38.8 %), with a
therapy are the cornerstones of treatment.444 probability of healing which was 1.44 times higher
in NPWT compared with the control group [RR:
NPWT in diabetic foot ulcers 1.44; 95 %CI: 1.03–2.01]. Healing time, defined
In 2004 the first guidelines for the use of NPWT as the time to complete wound closure, was
for DFUs management were published.445 The significantly shorter in the NPWT group (median
rationale for adopting NPWT in DFUs was related time-to-healing: 56 days) compared with the moist
to its capacity of removing exudate, protecting dressing group (median: 77 days; p<0.005); the
probability to heal, in any given point during follow- In the study by Armstrong et al.9 the possibility
up was 1.99 times higher in NPWT group. of converting patients to surgery was left to the
judgement of investigators and Blume et al.10
There were five major amputations in the moist- had a high drop-out rate in both groups. These
dressing treated group, while none occurred in the factors led the authors of the Cochrane review to
NPWT group. Considered altogether, major and conclude that the studies could be at risk of bias
minor amputations were 2/77 (3 %) in the NPWT and that any change in NPWT practice would need
group and 9/85 (11 %) in the control group; the to be informed by clinical experience and should
difference was not significant [RR: 0.25, 95 % CI: acknowledge the uncertainty around this decision
0.05–1.10].9
on account of the quality of data.14
No differences in adverse events—NPWT 40/77 Moreover, the technological evolution and new
(52 %), controls 46/85 (54 % ) [RR: 0.96; 95 %CI: methods such as instillation that have emerged after
0.72–1.28)—were observed between the groups. the conduct of these two studies (2005 and 2008) are
believed to have changed the scenario. With these
Blume et al. included 342 patients with DFUs of limitations, NPWT represents an important adjuvant
different aetiologies.10 These were randomised therapy in the management of DFUs, and its
into two groups: one was treated with NPWT, diffusion is increasing among the specialists, or for
the other with moist dressings, both as additions the increasing possibility of applying it in the multi-
to standard care. The patients were followed for dimensional management strategy of DFUs, which is
16 weeks and healing rates, healing times and complex and needs different approaches modulated
amputation rates were compared at the end of according to the stages of the pathology.
the period.10 There was a statistically significant
increase in the number of wounds healed in the The use of NPWT has also been described as a
NPWT group (73/169; 43.2 %) compared with the possible treatment strategy for other areas such
moist dressing group (48/166; 28.9 %). Healing as palliative treatment of wounds, necrotising
time was significantly shorter in the NPWT group, fasciitis, dermatology for example pyoderma
with median time-to-healing of 96 days [95 % CI: gangraenosum239 and neurosurgery.449,450
75.0–114.0], compared with the moist dressing
group, in which the median number of wounds
healed was not reached during 16-week follow- Cautions and contraindications
up. The study reported a statistically significant The following contraindications of NPWT have
(p=0.035) reduction in the number of amputations been established:451,452
in the NPWT group (4.1 %) compared with the
moist dressing group (10.2 %).10 • Clotting disorders (risk of bleeding) and acute
mild to moderate bleeding in the wound region
Although on different indications, postsurgical after injury/debridement
wounds and chronic DFU, the results of the two
large RCTs are unequivocal and demonstrate how • Exposed organs, vessels and vascular
NPWT may be safe and effective in the management anastomoses, which might be altered or
of DFUs. Nevertheless, some aspects related to the damaged by NPWT
characteristics of the studies and of the time when
they were conducted deserve some consideration. • Necrotic wound bed
• Untreated osteomyelitis removal of the focus of infection. Instillation
therapy is another option to be considered in
• Neoplastic tissue in the wound area. these cases.36,37 However, this is considered outside
manufacturers’ recommendations.
Risk of bleeding
If there is manifest bleeding or a risk of bleeding, Malignant wounds
NPWT must not be applied to the wound. In these NPWT is known to promote granulation tissue
cases, suction could result in a continuous removal growth and is therefore used for the purpose
of blood leading to significant blood loss.453 Some of improving tissue perfusion and enhancing
commercially available negative pressure systems granulation tissue formation. As a consequence, it
are fitted with a collection canister with a volume should not be used in the presence of malignant
of 300–500 ml and also have an audiovisual alarm neoplastic tissue.458 The consensus paper458
to alert the provider or patient if the canister is and other publications in the literature, as well
full. Blood loss can thus be prevented in time. as our own experience, suggest that NPWT
Additionally the bleeding can clot the foam and can be useful as a purely palliative measure in
therefore stop any function of the NPWT device. inoperable cases, for example, patients with a
gangrenous tumour or with a malignant cutaneous
Exposed vessels and vascular prostheses metastatic wound.458,459 Particularly in patients
Recent practical experience and theoretical with tumours that are not completely resectable
knowledge have shown that the use or non-use or with ulcerating lesions or highly exudative
of NPWT for the treatment of exposed vessels wounds, NPWT should not be strictly regarded as
and vascular anastomoses should be reconsidered contraindicated. When used as a purely palliative
and discussed. Over the last 15 years, there has measure, it allows wounds to be covered in a
been an increasing number of publications by hygienic and clean manner and at the same time is
different authors who investigated the use of more comfortable and less painful for the patient
NPWT in infected inguinal wounds after vascular without restricting any remaining mobility. In
surgery.390,391,393,454–457 In some cases, pieces of foam special cases, the presence of malignant tissue
were placed directly into the infected wound over in the wound bed can thus be considered an
the exposed vessel or the vascular anastomosis. indication for NPWT.460,461
In these studies, NPWT neither compromised
circulation nor caused any other complications.
NPWT and instillation
Necrotic wound bed NPWTi is a further development and modification
Necrotic tissue acts as a barrier to new tissue of conventional NPWT for the complementary
growth. The use of NPWT must therefore be management of acute and chronic wound infections
preceded by radical debridement. after initial surgery. The first publications date from
the year 1998.36 To date, there are 104 peer-reviewed
Untreated osteomyelitis articles that have been published on the subject
Due to the deep extension of a potential of NPWT in combination with instillation;
osteomyelitic focus, simple surface treatment is keywords: ‘instillation’, ‘instill’, ‘irrigation’; as of
unlikely to be successful, even if direct contact 31 December 2015 (appendix 2) and nine studies
between the dressing and the bone is ensured. comparing NPWTi with NPWT or standard
In this case, treatment must include the radical therapies (appendix 9).
Functional principle NPWT with instillation The first phase (instillation phase), lasts for
This modification of the conventional NPWT approximately 10–30 seconds, the vacuum line
involves the retrograde instillation of an closes, the instillation line opens and the instillation
antiseptic or antibiotic substance (for example, fluid moves through the first tubing to saturate the
pyrrolidinone homopolymer compound with foam and bath the total wound. During instillation,
iodine, octenidin dihydrochloride) into the pressure values above the atmospheric ambient
sealed wound.462 Between 1999–2012, several pressure are eventually reached in the foam and
refinements in equipment have provided the in the wound region. The wound surfaces are then
option of automatically controlled instillation completely in contact with the instilled solution.
therapy. This permits constantly controlled During the first instillation, the intake of the
instillation without burdening either the inflowing liquid by the foam and the expansion of
patient or the nursing staff. Using today’s the foam are monitored through the transparent
computer-controlled programmable therapy drape. The amount of fluid required for this phase is
units it is possible to automatically control entered in the software-supported instillation system
the instillation therapy, including the amount (for example, 75 ml).
of fluid, duration of instillation, soak time,
frequency of this therapy cycle. NPWTi has been After the closure of the instillation line, the in-
successfully used for adjunctive management and outflow remain blocked in the subsequent
of acute wound infections after surgical wound second phase, the wound cleansing phase. The
debridement.35,37–41,463,464 Several studies suggest instilled solution has unhindered access to the
that even non-infected wounds show a benefit wound surface, even in deep and piercing wounds.
in healing when treated by NPWTi using saline The duration of the active phase is variable, for
solutions in comparison to conventional NPWT antiseptic based on the pharmacodynamics of the
or standard moist wound treatment.43,465 fluids used, dwell time is usually 5–30 minutes.
Methods of action When the third phase—the vacuum phase—

Instillation therapy is performed during NPWT by begins, the original negative pressure is restored.
instilling the desired solution into the foam via a At the same time, the solution is removed by
dedicated tube system and then, after a set time suction together with the wound exudate and the
during which the solution is left to take effect and wound detritus. The duration of the vacuum phase
no suction is applied, removing the solution by is dependent on the clinical assessment of the
suction (continuation of the NPWT). In principle, virulence of the infection and the associated toxin
this alternation between NPWT and instillation production, and on the viscosity of the wound
periods can be repeated as often as desired. In exudates that affect the porosity of the foam. This
fact, the instillation should be performed several phase takes between 30 minutes and several hours;
times a day for a sufficient antimicrobial effect the standard setting is one to three hours.
for example. This should be done according to
a controlled time sequence: Instillation period Each instillation cycle corresponds to a normal
of the solution (saline, antiseptic or antibiotic dressing change. However, with the modern
solution; approximately 10–30 seconds), dwelling computer-controlled instillation system, the
period (dependent on the time the solution need number of ‘dressing changes’ is practically
to be effective, e.g. 20 minutes) – suction period unlimited, so that an uninterrupted intensive and
(e.g. 2–3 hours). effective wound management becomes possible.
For both patient and therapist, the number of drug-resistant bacteria wound infection after
time-consuming and often painful dressing liver transplantation (however, off label if
changes is substantially reduced. Instillation following open abdomen)467,468
therapy thus appears to be a patient-friendly
and cost-effective form of management for acute • Thoracic surgery: para- and post-pneumonic
and chronic infected wounds. Above all, it is the pleural empyema, bronchopleural fistula with
automation of the therapy unit that ensures the thoracic empyema, mediastinitis after cardiac
safety, effectiveness and treatment comfort of the surgery (however, this is off label)469–472
procedure. On the NPWT unit, the therapy unit
contains an integrated collecting reservoir for the • Severe periprosthetic infection in breast
instillation fluid that is removed by suction. reconstruction473
NPWTi versus irrigation-suction drainage • Trauma and orthopaedics: High-energy complex

Instillation therapy should not be confused with fracture, acute complex wounds of the lower
the irrigation-suction drainage described by extremities, endoprosthetic infections and
Willenegger466 in which a continuous directional high-pressure injection injuries, infection in
flow of liquid is generated that naturally takes the region of the implant bed (in many cases,
the shortest route along a pressure gradient asepsis was achieved even without removing
between the inflow via the infusion line and the the osteosynthesis material).474–479 However,
outlet via the drainage tube. With irrigation- treatment of these kinds of wounds may be
suction drainage, it is generally believed that dead limited due to the risk of fluid retention
spaces are created in the neighbourhood of these
‘irrigation routes’. These dead spaces can no longer • Necrotising fasciitis and gas gangrene.480–482
be reached by the irrigation solution after a few
irrigation-suction cycles and may thus persist • Chronic wounds such as diabetic lower limb
as septic ‘islands’. With instillation therapy the ulcers VLUs, PUs483–489
wound is, ideally, completely filled by the foam so
that the creation of ‘dead spaces’ is unlikely. • Uncomplicated wounds, where instillation
therapy can regenerate the porosity of the foam,
Indications for NPWTi which preserves the effectiveness of the seal
Current experience in the application of and extends the intervals for vacuum dressing
instillation therapy includes the following changes. With aseptic wounds, Ringer’s solution
indications for its use: can be used for instillation to increase granulation
tissue formation (appendix 9).252,488,490
• Septic wounds: soft tissue after initial surgical
debridement (acute infections, particularly • Painful wounds (postoperative wounds or
postoperative infections, are considered the infection-related conditions of pain occasionally
most favourable indications for NPWTi), might benefit from the instillation of local
osteitis, osteomyelitis (chronic soft-tissue and anaesthetics; this can also be an option when a
bone infections after surgical removal of the painful PU dressing change is anticipated).491
septic focus)
Fluids for NPWTi
• General surgery: abdominal sepsis, extensively Most often the time of NPWTi was 7–14 days,
however, one author group used NPWTi for infected wounds to support wound-healing, mostly
up to 3 weeks. 492
The following use of NPWTi by instillation of saline.
using different fluids for instillation (some
within and some outside the manufacturers’ Despite its growing popularity, there is a paucity of
recommendations): evidence and lack of guidance to provide effective
use of this therapy. Available evidence relating to
• 0.9 % normal saline: mean duration of NPWTi the use of NPWTi in acute and chronic wounds
for 12 days, 4 cycles per day, dwell times of is promising but limited in quality, being derived
either 5 or 60 minutes43,493–495 mostly from case series or small retrospective or
prospective studies. Nevertheless, the available
• Polyhexanide: 0.02 % or 0.04 %, 20 minutes dwell studies show that NPWTi is an effective treatment
time, for 4–8 days, 4–8 cycles per day.474,495–500 protocol. It has been shown to help reduce healing
time, promote long-term functional and positive
• Octenidine-based irrigation solution: 3 minute cosmetic outcomes in debilitated patients with
dwell time, for 4–8 days, 2 cycles per day.462,501 severe complex clinical situations, and potentially
help expedite wound closure.
• Acetic acid solution: 1 % solution, 20 minutes
dwell time, for 4–8 days,4–8 cycles per day497,502 The overview and literature analysis suggest that
NPWTi is, in certain clinical situations, more
• Super-oxidized water: repeated every 2–4 hours beneficial than standard NPWT for the adjunctive
with a 5–10 minute soak time483,503 management of acutely and chronically infected
wounds that require hospital admission.488
• Dakin’s solution: 10 minutes every hour, diluted
12.5 % for 10 days503,504 Additionally, there are clinical observations that
NPWTi by saline is more effective in wound
• Potassium permanganate solution: 1:5000 505
healing that NPWT alone, creating the question
in which indications principally NPWTi-saline
• Antibiotic solution: such as doxycycline, colistin should be given and when not. As a future
and rifampicin36,468,506,507 direction it should be scientifically clarified and
evaluated in terms on cost-effectiveness, whether
• Insulin508,509 all non-infected wounds should be treated by
NPWTi-saline.270,510,511
NPWTi is increasingly used as an adjunct therapy
for a wide variety of acute and chronic wounds.
In the last ten years, particularly, NPWTi has ciNPT
played a role in the adjunctive management In industrialised countries, SSIs occur in general
of postoperative infected wounds. The use of surgery in about 5 % of patients and in high-risk
instillation has enabled conventional NPWT to surgical procedures reaching over 50 % lengthening
be extended in these difficult situations by using the average length of stay of 12.6 days.512
antiseptic and antibiotic solutions. Nevertheless,
the literature shows that the role of NPWTi SSIs burden patients, their families, the health-
continues to expand and can be used today also in care system, and society with loss of productivity,
the management of both acute and chronic non- prolonged hospital stays, increased health-care
provider visits, and increased financial costs. With The search covered papers published in the period
a mortality, e.g. in cardiovascular surgery of up to from 1 January 2000 to 31 December 2015. The
50 %, DSWI, are a rare but devastating complication keywords included: ‘prevention’, ‘negative pressure
after median sternotomy for cardiac surgery.513 wound therapy’, ‘NPWT’, ‘active incisional
management’, ‘incisional vacuum therapy’,
Current standards of care for preventing SSIs ‘incisional negative pressure wound therapy’,
include the implementation of defined procedures ‘incisional NPWT’, ‘incisional wound vacuum
and standardising processes using preoperative assisted closure’, ‘closed incisional negative
prophylactic systemic antibiotics, preoperative pressure therapy’, ‘wound infection’. A limited
soap or antiseptic shower/bath, aseptic incision number of robust, prospective, randomised,
site surgical preparation and sterile and meticulous comparative, controlled studies on ciNPT use over
surgical technique. Thus, several author groups try closed surgical (all surgical disciplines) incisions
to reduce the SSI rate by new incision devices (like that might most benefit from this therapy exist.
cold-plasma scalpel), new suture techniques and The literature search identified 116 (appendix 7).
products including disposable electrocardiogram Since 2009, several RCT’s (n=7) and meta-analyses
leads and pacing wires, antibiotic-coated sutures, (n=3) have described the effect of NPWT on closed
and silver-impregnated dressings, wound irrigation incisions in all surgical fields (table, appendix 10).
and iodine-impregnated skin drapes. Additionally, These studies encompass various wound types
some authors tried to reduce the DSWI rate and surgical interventions, including high-risk
by the implementation of comprehensive, open fracture types (tibial plateau, tibia, pilon,
multidisciplinary wound management team. calcaneus), total knee replacement procedures,
Yet, the continued high SSI rates in surgery lower extremity amputations and elective, open
demonstrate the need for further preventative colorectal resection. Enrolled patients often had
methods. Traditionally, surgeons have closed comorbidities, including obesity (BMI ≥30 kg/
surgical incisions with primary intention using m2), diabetes mellitus, peripheral vascular disease,
sutures, staples, tissue adhesives or a combination or chronic obstructive pulmonary disease. The
of these methods. Now, surgeons from several two studies reported no differences in SSI rates
disciplines have recently discovered that NPWT or dehiscence between ciNPT and control (silver
applied over closed incisions can also be beneficial impregnated wound dressings or sterile gauze
in preventing incision complications. The term dressings) groups.366,514 Of these one study was
ciNPT refers to any type of NPWT using fluid- stopped prematurely due to blister formation in a
absorbing dressings over closed incisions. majority of ciNPT group patients.515
Literature review: randomised trials The most recent meta-analysis performing an

Since 2004, numerous published studies have evaluation of the effectiveness of ciNPT in lowering
reported improved incisional outcomes using the incidence of SSI compared with standard
ciNPT across all surgical disciplines. Against this dressings was based on a literature search, which
background, we analysed the available DSWI was conducted to find all publications (not only
and ciNPT in surgical incision management. RCT’s) comparing ciNPT with standard incisional
Our goals were to determine whether and care.516 This study used fixed-effects model to assess
how ciNPT is beneficial in preventing wound between-study and between-incision location
incision complications and then to formulate subgroup heterogeneity and effect size. Additionally
recommendations for potential indications for use. funnel plots were used to assess publication bias. The
authors demonstrated an overall weighted average formation.527 In this way, the therapies involved
rates of SSI in the ciNPT and control groups were in the decrease of myofibroblasts numbers might
6.61 % and 9.36 %, respectively (relative reduction potentially have a positive effect on scar cosmesis
in SSI rate of 29.4 %). Furthermore, the authors and thus in functionality.517
could show that the odds of SSI decrease was 0.496
(p<0.00001).516 Overall rates of dehiscence in Tissue perfusion
ciNPT and control groups were 5.3 % and 10.7 %, There are few reports on ciNPT on the effect
respectively. The results of this meta-analysis suggest of perfusion adjacent to closed incisions.
that ciNPT is a potentially effective method for An experimental study shows that while
reducing SSI and may be associated with a decreased conventional NPWT affects perfusion in defect
incidence of dehiscence. wounds, there is little effect on perfusion in
incisional wounds.44
Mechanism of action of ciNPT
There are a number of articles that deal specifically Oedema
with the mechanisms of action of NPWT over An experimental study in pigs indicated an
closed incisions.44,517–520 The evidence supports the effect by NPWT over closed incisions in oedema.
hypothesis that reduction of lateral tension and The results from studying how radiolabel
haematoma or seroma, coupled with an acceleration microspheres are cleared to lymph nodes beneath
of the elimination of tissue oedema, are the main incisions treated with NPWT suggested increased
mechanisms of action of incisional NPWT. lymphatic drainage.520
Lateral tension Haematoma and seroma

NPWT on closed wounds seems to reinforce Collections of blood and serum in sub-incisional
the wound by reducing the lateral tension in tissues create dead spaces that may predispose the
suture lines. The wound will then gape less and patient to infection. NPWT over closed incisions
the risk of scarring may decrease. Reductions in has shown to result in reductions in haematoma
lateral tension have been demonstrated during volume.518,520,528 This has also been demonstrated
NPWT with computer modelling and in vitro clinically for seroma in a small RCT.529–531
measurements.517 There is similar data that
non-NPWT mechanical forces can stress-shield Reduction of surgical site infection rate
closed incisions and reduces scarring.521 There Infection of the wound has been indicated (for
is also evidence from animal studies that the the first time in 1994) as the aetiological cause of
breaking strength of wounds is increased through the ‘delayed healing of the wound’.532 By reducing
the application of continuous NPWT to closed seroma and haematoma formation the risk of
incisions.518,519 Bolstering appositional forces at wound infection might also decrease as the wound
the incision through reduction of lateral tension can heal without a persisting open entrance for
improve scar cosmesis.522 Collagen synthesis and bacteria. Haematoma are thought to serve as
its organisation are influenced by mechanical rich nutrient sources for infection.533 Wound
stimuli. 523,524
Furthermore, the transformation infection leads to tissue breakdown and then
from fibroblasts to myofibroblasts is affected surgical wound dehiscence, through interference
by mechanical stimulation525 and they play an with normal cellular mechanism of wound
important role in producing excess extracellular healing and devitalisation of underlying tissue.450
matrix 526
and thus in the hypertrophic scar Some authors pointed out a lower incidence of
SSI450,534 after ciNPT in cardiac surgery,380,382 and example, seven days or up to the removal of
orthopaedic surgery. 535
However, none of these the sutures
studies had a control group for comparison.
Other studies with a control group also reported a • An integrated, one-piece dressing comprised
lower incidence of SSI in colorectal surgery,536–541 of a polyurethane film with acrylic adhesive
caesarean section, 542–545
total ankle arthroplasty, 546
that provide adhesion of the dressing to
abdominal wall reconstruction,547 spinal surgery,450 the surrounding skin of the incision and a
groin vascular procedure403 and in CABG.379,383,548 polyurethane shell that encapsulates the foam
Stannard et al. in 2006 reported in a pilot bolster and interface layer, providing a closed
prospective RCT no significant difference between system. The dressing is connected to the small
the ciNPT group and control group in terms of and portable single-use battery-powered NPWT
infection or wound dehiscence.160 The same group, device with a canister of 45 ml that produces a
in 2012, reported the results of a multicentre continuous negative pressure of −125 mmHg for
prospective randomised trial on a greater number seven days
of patient with the same characteristics stating
that the incidence of infection and dehiscence • A portable single-use canisterless device with a
was lower in the ciNPT group.528 Masden reported dressing composed of a silicon contact layer to
a RCT in which there was no statistical difference minimise pain of removal, an airlock layer that
in the incidence of infection and surgical allows even distribution of negative pressure
wound dehiscence (SWD) between the ciNPT across the dressing, an absorbent layer that
and comparative dressing groups.514 In another moves exudates away from the wound, and a
study no difference again in surgical wound high moisture vapour transmission rate top film.
complication for abdominal wall reconstruction The dressing is connected to a ultra-portable
incisions has been reported.549 single-use system, with a continuous negative
pressure of −80 mmHg for seven days.
ciNPT systems
The technology of ciNPT has recently been Overall, a majority of these case studies reported
developed to involve the application over surgical that ciNPT use was associated with decreases
incisions. Special wound dressings have been in wound complications, wound dehiscence,
are designed to be applied over closed incisions. haematoma/seroma formation and reduction in
These are made of a material that has high-skin SSI. To conclude from the experience to date:
compatibility, such as a silicone adhesive. Wound
fillers such as foam or gauze should not be applied • ciNPT is used in many different surgical
directly on intact skin. The ciNPT systems described disciplines: trauma and orthopaedic surgery,
in the literature today (2017) are represented by: plastic surgery, general surgery, colorectal
surgery, hernia repair surgery, post-bariatric
• A polyurethane foam placed over the length of surgery, thoracic and cardiovascular surgery,
the incision, secured with a protective occlusive vascular surgery, obstetrics and urology
tape and attached to a commercially available
NPWT device set at between −75 mmHg and • The present state of knowledge is that there is no
−125 mmHg, in a continuous suction. Using rationale to apply ciNPT to all surgical incisions
this system, the surgeon can decide how long because the costs are too high in comparison
the ciNPT system should be on the incision, for with that of standard dressings366,550
Fig 3.The new algorithm in the treatment of wounds when using NPWT. Change from
the old FIX (if there is a fracture) and FLAP (to close the wound) concept to the new
FIX–NPWT–FLAP concept (if the wound closure will be not possible).552, 553 The right
box (NPWT, NPWTi, ciNPT) shows different purposes of the NPWT
Debridement
NPWT, NPWTi, ciNPT
YES • Temporary wound closure

Fracture Fixation • Facilitating second look
• Wound bed preparation (WBP)
NO • Delivering saline for WBP
• Bridging up to reconstruction
• Exudate management
• Wound cleaning
Definitive wound closure • Micro-debridement
(Reconstructive ladder) Wound closure NO • Decontamination
YES possible? • Hygienic wound closure
• Free flap
• Fixation of skin graft, substitutes
• Distant/ local pedicled flap
• Delivering antiseptic or antibiotic
• Local flap
substances, infection control
• Tissue expansion
• Prevention of SSI (surgical site
• Bioartificial dermal
infection
substitute
• Skin graft
• Delayed primary closure
• Skin closure, primary YES
intention
• Secondary intention (Sint)
Risk YES
factors for
SSI?
NO
• Therefore, every surgical discipline or the debridement is performed first, then NPWT is
scientific societies of various surgical specialities used as bridging therapy, and free flap could be
have to create a risk profile of operation and considered for definite soft tissue coverage.551 To
patient-related risk factors for surgical wound date, there are no published recommendations in
complications and then determine a cut-off the literature about the best timepoint to start or
marker for the decision to apply ciNPT. stop NPWT. Searching with the keywords ‘interval’,
‘timepoint’, ‘time’, ‘delay’, ‘start’, ‘stop’, ‘end’
the only information found was about possible
When to start, when to stop delays and allowed time intervals between primary
(achieved endpoint) wound debridement and the definitive closure

by methods of the reconstructive ladder. There
When delayed reconstruction is inevitable, radical is no detail about the best timepoint to start
NPWT if wound closure is not possible and no Sometimes, reconstruction in high-risk patients
information how long the treatment will be useful with severe lower extremity injuries will be delayed
(Fig 3). Additionally, there are no evidence-based due to the patients’ critical condition, advanced
time intervals specifying when NPWT should be age, medical comorbidities, heavily exuding
changed after initial placement in such cases, wounds and questionable viability of soft tissues.
however, manufacturers instructions specify 48–72 In these situations, NPWT will be an adjunct to
hours between dressing changes. delayed soft tissue reconstruction in patients with
complex lower limb trauma, with NPWT bridging
Nevertheless, based on the available experience, up to reconstruction.298 But how long can this
some published data and recommendations time delay be between initial debridement and
of the manufacturer, it is possible to make a the closure of the wound bridged by NPWT? The
differentiation of the start and stop timepoints, study showed evidence to support NPWT beyond
duration of the therapy and senseful dressing 72 hours without increased infection rates and to
change intervals between the different purposes support a reduction in flap rates with NPWT.262
of the NPWT (Table 1). However, one author group showed that NPWT
Table 1. Recommendations for starting and stopping timepoints of NPWT in

different settings of NPWT-use
Purpose of NPWT Start Stop Dressing change
intervals
Temporary wound closure (TWC) NPWT: immediately ASAP up to wound closure 2–4 days
(based on: exudate management, micro- after debridement (ReconLadder) or SInt
debridement and decontamination)
Facilitating second look ASAP, up to starting with If contaminated
WBP, TWC <48 hours
Wound bed preparation (WBP) ASAP, up to wound closure 3–4 days
(ReconLadder) or SInt
Delivering saline for WBP ASAP, up to wound closure 3–4 days and in some
(ReconLadder) or SInt cases 5–7 days*
Bridging up to reconstruction ASAP–wound closure 3–4 days
(ReconLadder), if possible
within 7 days
Hygienic wound closure ASAP - wound closure 3–4 days
(ReconLadder)
Fixation of skin graft or skin substitutes NPWT: after skin 5–6 days, artificial skin No planned dressing
(Integra, Matriderm) transplantation substitutes up to 10 days change
Delivering antiseptic or antibiotic NPWTi: immediately Up to wound closure, vital 5–7 days
substances after debridement, and clean wound bed, total
initial wound care bacterial clearance not
necessary
Prevention of SSI ciNPT: immediately Between 7 days and No planned dressing
after closure of incision timepoint to remove stitches change
(e.g. 12 days)
ASAP–as soon as possible, SSI–Surgical site infection, SInt–Secondary intention: *Most companies recommend 2–4 days
may help reduce the flap size and need for a especially in polytraumatised patients.556 This
flap transfer for type IIIB open tibial fractures group of patients had been referred from a trauma
and that prolonged periods of NPWT usage, centre at a mean interval of 19 days (range: 1–96
>7 days, should be avoided to reduce infection days) after the trauma event with temporary
and amputation risks.554 Other authors support NPWT (purpose: bridging to reconstruction and
this algorithm. They showed that patients who wound bed preparation) on their wounds after
underwent definitive coverage within 7 days initial fracture fixation and initial debridement
had a significantly decreased rate of infection of necrotic tissue. Flap reconstruction was thus
(12.5 %) compared with patients who had only possible later than 72 hours and definitive
coverage at 7 days or more after injury (57 %) reconstructive wound closure was achieved at
(p<0.008).555 They concluded that the routine a mean time of 28 days (range: 3–106 days). In
use of NPWT with severe open tibia fractures is clean and vital wounds a 7-day interval between
safe and provides a good primary dressing over dressing changes during NPWT for open traumatic
open wounds, but NPWT does not allow delay fractures was shown to be acceptable.252
of soft-tissue coverage past 7 days without a
concomitant elevation in infection rates.555 Against the background of the lack of high-grade
evidence-based recommendations, it has to be
The result of a retrospective analysis shows formulated that NPWT in all NPWT-settings should
the flap reconstructions performed beyond start immediately. There are no reasons to delay.
the frequently quoted critical interval Additionally, there is no controversy to follow with
yielded similar results to those of immediate NPWT for 10–14 days (except for fixation of skin
reconstruction within the first 3 days, as reported graft where 5–6 days is recommended). But every
in the literature. This strategy may reduce the use of NPWT must be able to be justified in the
importance of emergency reconstructions, treatment team.
6. Patient perspective
T
his chapter describes the patient Overall quality of life
perspective of being treated with NPWT. The concept of QoL is defined as those aspects
The literature presents varying results with that can be clearly shown to affect health, either
both negative and positive impact on the patient’s physical or mental health.557 QoL can be measured
QoL. NPWT affects the patient’s life in all aspects, by two basic approaches: generic instruments that
physical, psychological and social. The patient provide a summary of QoL in general terms, and
perspective may be described either qualitatively disease- or condition-specific instruments that are
(as the patient’s lived experience) or quantitatively adapted to different diseases or conditions.558
(in measuring the patient’s QoL in different
domains of daily living).557 Only a handful of studies have quantitatively
assessed how the patients rate their QoL while
Patients undergoing wound treatment have being treated with NPWT and the literature
different focuses, concerns, and needs related to presents varying results with both negative and
treatment modality. Patients treated with NPWT positive impact on the patient’s overall QoL.
have experiences that differ from the experience The majority of the studies show higher QoL
of patients treated with conventional treatment estimation with patients treated with NPWT
with dressings. The knowledge of these unique compared with those treated with traditional
features of the experience of patients treated dressings. This result could be explained as being
NPWT is required for the possibility to perform due to patients treated with NPWT experienced less
individualised care, which is the goal of all pain, promotion of wound healing and subsequent
health care. faster discharge from hospital.559 In a pilot study
comparing overall QoL over a 12-week period,
In the clinical use, NPWT has sometimes been no statistically significant difference between
viewed as a ‘simple dressing’, which could be patients treated with NPWT and with traditional
considered as ignorance of the risks and safety dressings was noticed. The patients treated with
issues with the treatment. This phenomenon is NPWT, however, rated their social functioning
also seen in regards to the impact the treatment higher after two weeks treatment. The authors of
has on the patient. The patient treated with the study suggest this improvement may be due to
NPWT is dependent on a medical device for methodological issues of the study such as small
optimal health. NPWT is not a completely sample size and no baseline data.560
safe treatment and there are adverse effects.
Therefore, it is important to focus on the Treatment with NPWT does not seem to worsen
patient’s experience and to empower them in the patient´s overall experience in QoL, however
coping with the treatment so that the treatment research shows that in some domains, the patients
itself does not become worse than the wound. do rate their QoL lower. It is especially in physical
functioning that the patients express deterioration pain139,187,188 probably due to less ingrowth of tissue
in QoL, sometimes severe enough that the in the wound filler. Another effect of the gauze as
treatment must be terminated.561–563 wound filler is to ease the pain when applying the
pressure due to less contraction in the wound by
gauze compare with foam.139
Physical aspects
Pain Pain and trauma can also be caused by removal
Pain is a common symptom for patients going of film-based dressings with adhesive skin contact
through wound treatment.564,565 The literature show layers that are used to keep NPWT systems in
diverse experiences of pain in patients treated with place. Skin stripping may occur because the film
NPWT. Some studies imply that patients treated can adhere too aggressively to the periwound
with NPWT experience much pain with difficulties skin. A solution for this problem may be to
coping with regular pain killers.236 While other choose a soft silicone film instead of an acrylic
studies show no significant differences compared adhesive-based film.240
with regular dressings or that NPWT seems to
reduce the patients’ levels of pain.236,395 Research Physical discomfort
showed that patients treated with NPWT have a Patients treated with NPWT also describe other types
huge focus on the machine and its functioning, of physical discomfort besides pain. Being attached
an explanation could perhaps be that this focus to the machine 24/7 seems particularly problematic
is overshadowing the patients’ pain experience and bothersome.566,569 Being forced to carry the
so that they do not perceive the pain in the same device all day also restricts daily living with regards
way as if they were to be treated with traditional to mobility and physical functioning. Even though
dressings instead.566 it is said that the patients are treated with a so-
called mobile device it is of considerable weight that
The literature shows that some procedures in the patients describes it as problematic to carry,570 one
wound treatment process are more painful than patient said:
others especially during removal of the wound filler,
particularly foam, and when applying the negative ‘You couldn´t even go into the kitchen without
pressure.236,567 To cope with the problem of pain carrying it. It is a great burden.’569
during dressing removal lidocaine may be injected
retrograde up the suction tubing into the wound The industrial development in recent years has
filler before removal the pain experience of the been drawn to smaller and more portable devices.
patients has shown to be reduced in this way.236,241–243 The treatment results in smaller wounds do not
seem to differ from the larger devices and the
It is described in the literature that usage of advantage for the patients is in terms of QoL
regional pain blocks may be an effective way of gains when allowing them to be more mobile.571
managing pain when patients ask for terminating There seems to be no difference in pain and
the treatment due to severe pain burden. 568
patient satisfaction between the devices but major
advantages for smaller ones concerning overall
Another way to manage pain during treatment activity, sleep and social interactions.162
could be to choose gauze or PVA-based foam (white
foam). It has been suggested that there is evidence Sleep
for choosing these kinds of wound fillers to reduce Sleep disturbance during treatment with NPWT
has been described in the literature. Thus the Stress
problem exists although it does not seem to be Many patients describe treatment with NPWT as
of major severity or of an unmanageable kind. In being stressful. The most common source of stress
a study by Upton and Andrews, 56 % of patients mentioned is the organisation of the dressing
reported some level of sleep disturbance.572 The changes. This is particularly a problem when
patients rated their problem with sleeping as a dressing changes take place in the operating
mean score of 2.98 on a scale of 0 to 10.572 A factor room and the patient has to wait, fast all day and
contributing to sleep disturbance during treatment then often is down-prioritised meaning that the
is having to sleep in an uncomfortable position dressing change sometimes gets postponed to the
due to both the equipment and the fear of causing next day.570
the machine to shut down. 566,572
In particular,
fear of tearing off the draining tube from the ‘So that a … well … that part was an
dressing was present, which led to some patients inconvenience, to have to wait not knowing if the
being afraid of moving around during sleep and change of dressing could be done that day … all of
reporting only sleeping on their back.566 a sudden it could not be done and then you did not
know when next a change could be performed …
‘Entangles me in the drainage tube’566 well you must get a scheduled time for the change
of dressing.’570
‘Slept badly. Everything feels hopeless.’ 566
Anxiety
Patients treated with NPWT that experienced some Patients treated with NPWT may experience
pain relief associated with the treatment did rate increased levels of anxiety compared with
their sleep significantly better than those treated patients being treated with traditional
with dressings.9 dressings.236,573 This seems especially present
in the group of patients policlinically treated
in their home instead of being admitted to
Psychological aspects hospital.236 These patients mainly describe their
Body image experience with the treatment that they feeling
Treatment with NPWT has been described in the abandoned by the health professionals, coping
literature as potentially affecting patients’ body with the treatment on their own which creates
image and view of themselves. This is probably a feeling of being insecure and unsafe. Lack of
due to being attached to a machine that makes a follow-up and difficulties in knowing where
constant reminder of them having a wound and to turn when something goes wrong with the
for others to notice. There have been described treatment is described by several of the patients.
gender differences in this aspect. Appearance seems This is something that needs to be addressed by
to be the most problematic for female patients the health-care system in order for the patients
while the sound of the machine was expressed by to feel that they are being cared for even when
the males as the most embarrassing. These feelings being treated outside the hospital or other
resulted in the patient living a restricted life.569 health-care facilities.566
‘It made me feel very, very uncomfortable and very Fear and anxiety regarding malfunction of the
shy with it. Maybe not shy, but embarrassed … it machine or that the patients themselves are doing
was so awkward and ugly.’ 569 something wrong that will make the treatment
fail is constantly present. They are focussed on the their social life and getting isolated.574 However,
machine which makes it hard for them to relax: there is research saying that social functioning
has been improved during the treatment.561 It
‘I am constantly afraid that the machine will be may have to do with these patients receiving
squeezed and be turned off – check it all the time.’566 a treatment that fits well, no leakage of the
dressings and that the device actually dealt with
By providing the patients with a proper education in the possible odour making patients feel that they
the functioning of the machine and informing them can more easily move out of the social context.
what they should do if the alarm of the machine Familiarity with and feeling secure about the
sets off, a confidence and feeling of manageability is device can be a key so that patients are not
created, which reduces the anxiety.566 ashamed of it.
Staff competence Family and friends

Since NPWT is a relatively new treatment method The patient’s family plays a major role during
the literature shows that health professionals the treatment. Patients express being really
are not always up-to-date and skilled in the dependant on the support of their family and
performance of the treatment. This also leads to friends to feel secure and comfortable during the
feelings of being insecure and unsafe together with treatment.236,566,575 In particular, female patients
different levels of anxiety and misbelief of health experience the burden of being dependent on
professional in general.566,569,574 Some patients, their family for assistance and support, while male
however, express an understanding regarding some patients relied more on health professionals.569
deficiencies in the competence of the staff since
they were aware that the treatment was new, some ‘Had to get (husband) to help me with everything
even expressed an interest in being part of the (pause) everything ... very, very incapacitated that I
staff’s education.566 couldn’t do it myself.’569
Family members themselves may also describe being

Social aspects affected by the treatment, for example, by being
Isolation and stigma disturbed by the device itself or by the sound of the
The patient’s social life may also be affected alarm, and it can interfere with night sleep.236,566
during treatment with NPWT. The literature
describes how patients can experience it as
annoying and embarrassing to be in social Patient and family
settings with the device, that it looks strange and
caregiver education
makes a lot of sound:
NPWT is not an entirely safe treatment without
‘I was glad it was winter because I could cover up complications. In December 2009, the FDA
with a dark coat … I was conscious of it … I didn’t issued a notification regarding safe use of the
want other people to see it.’569 treatment and stated that the most severe injuries
and deaths associated with NPWT occurred at
Some patients also describe being concerned that home or in long-term care facilities.576 To ensure
those around them will perceive a bad smell. This safe and correct use of NPWT it is important
can lead to the patients feeling awkward, from to educate the patients thoroughly. It has been
suggested that lack of education of patients • Knowledge on how to troubleshoot device alarms
and caregivers may have been a risk factor for
complications, especially when being treated at • Competence in application and reinforcement of
home.577 It is recommended that the education the dressing
of patient and family starts at the beginning
of treatment and continuities throughout the • Knowledge in recognition of signs and
patient’s hospitalisation. It is then essential that symptoms of upcoming complications
staff, before discharge, ensure that the patients
and family caregivers are prepared to apply the • Preparedness to respond to emergency
device, are able to monitor the therapy and can situations.577
respond appropriately to issues that may arise
during treatment.577 Knowing where to turn to when something
happens while being treated at home is described
The content of the education has been in the literature as a key factor for the patients to
recommended to contain: feel confident with the treatment. Unfortunately
this seems to be a frequent problem for the
• Written patient instruction regarding safe patients with a feeling of abandonment and
operation of the device increased levels of anxiety as a result.566
7. Organisation of NPWT
Organisation of care Short- and long-term goals

The organisational aspects of NPWT are of It has to be recognised that the initial indications
particular interest because NPWT might be for NPWT, so-called short-term goals, which are
provided not only as a device/technology, but usually defined in-hospital, are different to the ‘long-
also as a service, including different purchase or term’ goals, frequently guided by the out-patient
rental models, maintenance systems and cross- treatment plan. The short- and long-term goals
sectional coordination. must be individually defined for every patient and
laid down in their treatment plan.371
This chapter deals with the organisation of
NPWT in the hospital, primary care and home- Short-term goals include:
care settings. It establishes an overview of the
circumstances involved in NPWT organisation in • Dressing solution
the different settings and provides guidance on
which aspects to consider when organising the • Management of wound exudate
treatment setup.
• Management of wound odour
NPWT at different levels • Pain management to achieve a reduction in pain

NPWT was initially introduced in hospital care,
frequently for acute, traumatic and or post- • Prevention of infection.
surgical wounds.578 This then extended to the
treatment of hard-to-heal wounds of other Long-term goals include:
aetiologies in other hospital-based disciplines.
Today, NPWT can be applied under different • Reduction in wound exudate volume
circumstances. It can be used in home care,
outpatient or inpatient settings. All three levels • Intended wound closure through secondary
come with different requirements and conditions suture or secondary intention healing
for the clinician, the patient and the carers.
• The production of healthy granulation tissue
These requirements are widely different when
treating a patient in a closed environment such as • A reduction in wound area.
an inpatient ward with continuous observation or
in an outpatient facility or at the patient’s home
due to the challenges and demands for optimal use Reimbursement
of the technology. One key issue in the use of NPWT as a technique
or service is how it is reimbursed and also whether appropriate use of the devices, France, Germany,
it is introduced as device only or as a service Italy and Spain rely on companies to deliver the
delivered by the company. This has a substantial training to staff, whereas in the UK both companies
impact not only on organisational care, level of and expert clinicians provide training for staff.
care and health economics but also on legal issues.
The availability of treatment protocols also varies
The reimbursement situation in Europe is complex greatly, from no protocols in Germany to regional
and varies not only among countries but also from protocols in France. In Italy protocols exist in some
region to region579 as illustrated by examples in regions and at the hospital level in other regions. In
(Appendix 11). the UK protocols exist exclusively at the individual
hospital level, which is also true in Spain, however,
Our analysis shows that in the five countries protocols only exist in some instances.
from which we were able to obtain data (France,
Germany, Italy, Spain and UK), two had defined Since the reimbursement and the system for
national reimbursement structures for NPWT. implementing NPWT have a substantial impact
The remaining three had no national system in not only on the organisation of care, but also on
place, leaving it up to regional or hospital budgets the health economic evaluation and use of NPWT,
to allow for the reimbursement. Also, while the the challenge to compare NPWT is substantial
device might not be reimbursed, the treatment since there is such a variation among countries and
might be reimbursed as a dressing change. The within regions.
reimbursement situation for use of NPWT in
the home care setting also seems fragmented.
In Italy home care NPWT is not reimbursed; NPWT in different settings
however, exceptions exist in Piedmont, Tuscany Hospital
and Sicily. In Germany reimbursement is granted Most European hospitals have typically chosen
on a case-by-case basis, and Spain rarely offers one particular NPWT system to be used across the
reimbursement. In the UK, NPWT in the home hospital. Patients will, therefore, mostly continue to
care setting is reimbursed, but not for multi-patient use the same system as the one they were introduced
devices and France reimburses the treatment in to in the hospital if the treatment was initiated
home care, however, not in community care. there. NPWTi only makes sense in an inpatient
(Appendix 11). setting, while ciNPT, which is usually initiated in
hospital, is now seeing more outpatient use.
The means of delivering NPWT also vary greatly,
with all five countries both leasing and purchasing Hospitals have treated patients with NPWT for
the NPWT devices. In terms of training staff in the a long time and provide the best conditions for
the application, including sterile procedure room, medical conditions and treatments such as NPWT. In
optional anaesthesia, fast availability of analgesics, 2016, for example, new DRGs for NPWT in vascular
and trained staff and continuous observation surgery have been introduced.
of the patient. In the hospital, patients and/or
caretakers can be taught how to use the NPWT Outpatient care is also covered by the standards of
device on a regular basis integrated into daily medical care; however, the full costs of treatment
management. NPWT has also been integrated are not covered. The patients are divided into
into hospital-based outpatient facilities. On initial care levels by the medical service of the health
application of NPWT, the patient and the dressing insurance companies, which determines the
should be closely monitored for at least 24 hours amount per month to cover costs for care services,
to make sure that possible bleeding and other such as outpatient treatment.
complications are detected as soon as possible and
that the necessary steps can be taken. In the UK, for example, the co-ordination of NPWT
is often conducted by the tissue viability service,
Primary care which supports both medical and ward-based
NPWT has been introduced in outpatient nurses in the application and management of
facilities that are not hospital-based, initially for NPWT. The tissue viability service also co-ordinates
postsurgical wounds, but later for complex and discharge to the community, if continued NPWT
hard-to-heal wounds. How often it is introduced is required. Here, both doctors and nurses perform
in outpatient facilities is related to the health- dressing changes. Consumables are reimbursed via
care system and the reimbursement system in the UK Drug Tariff but multi-patient use devices
each country. are not. Single patient use NPWT is reimbursed on
the UK Drug Tariff.
For example, in Germany, suitable NPWT devices
and dressing materials are chosen and dressing In the Swedish system, primary care and hospital
changes are performed by ambulatory care care are mainly separated in their organisation.
providers, including GPs, surgeons, inpatient and Primary care is run by the municipality and
outpatient clinics or by specialised nurses. hospital care by the county. Private care in both
care levels is also available. This can often be a
Every citizen living in Germany is required to have problem when one care provider initiates NPWT
health insurance. Based on individual income, and the other takes over the care of the patient in
coverage can be chosen as part of the Statuary or a later stage of treatment. In Sweden, everything
Private Health Insurance schemes (SHI/PHI). In is based on the tax system and, frequently, the
coordination with government health policies, the reimbursement of NPWT as a technology is paid
health insurance companies develop catalogues of for by the hospital (county) whereas the staff is
minimal service standards, which are then adopted paid for by the authority.
as ‘standards of medical care,’ which everyone has
the right to benefit from. Home care
Hospital patients are now discharged earlier than
Hospital care is covered by the standards of medical before580 and as a consequence, more patients
care and is billed according to the diagnosis related (including those with wounds) with a complex
groups (DRG) system. The different medical pathological condition are being treated in a home
specialisations have their own cost codes relating to care setting.581
For the purpose of this document we follow the can vary greatly.19 Differences in contracting may
definition from the 2014 EWMA Document ‘Home mean that community services within a hospital
Care-Wound Care’ in which wound-related home catchment area can use different NPWT systems
care is defined as and have different support structures. This can be
a particular problem when patients with complex
‘the care that is provided by health-care wounds requiring NPWT are discharged from
professionals and families, also called informal tertiary referral centres or even when patients are
carers, to patients with wounds living at home.’19 transferred between hospitals.
The use of NPWT in the home care setting varies In Sweden there is advanced intensive care in the
greatly among countries, which can be explained home performed by specialised nurses. They can
by the differences in health-care systems and the manage NPWT in the patient’s home. For home
reimbursement for the treatment in this setting. care in a less advanced setting no specialised
personnel are required, therefore, the care is
In Germany for example, NPWT is not reimbursed also dependent on the health-care personnel’s
in general, but on a case-by-case decision, depending individual competence.
on the statutory health insurance (SHI) company.
The treatment of patients at home in Germany
involves coordination between the home care Basic concepts in the
supplier and the SHI to obtain approval and
organisation of NPWT
reimbursement for the treatment. The home care
supplier applies for a treatment guarantee and treatment
organises the device and the equipment required; The following provides insights into what is
the supplier facilitates coordination between the required for the organisation of a NPWT setup
attending physician, the nursing service and the that enables safe treatment and secures transfer of
patient, if the latter is to receive NPWT in a non- knowledge as well as the proper expertise.
inpatient setting. The home care supplier is not
allowed to perform NPWT-related dressing changes, It is self-evident that such a setup requires that staff,
which must be performed by a GP or a surgeon in equipment and permissions are in place, which is
outpatient clinics. In the meantime, patients are why we will focus on the following points.
usually not transferred from the inpatient setting
until a guarantee for the reimbursement from the • Access and service support
SHI has been obtained since most applications
for this kind of guarantee have been/are denied. • Responsibility
However, home care providers or producers of
NPWT devices might cover the costs (in advance) • Organisation of network supporting the patient
until the guarantee is given.
• Staff education
In the UK, commissioning of wound care services
and purchasing contracts for medical devices
is locality based and, as a result, equipment for Access and service support
NPWT and the support services necessary for the Inventory and single-purchase models
safe delivery of this form of wound management Hospitals have different regulations for access to
NPWT devices. Some have established a depot with Leasing model
a certain number of devices available. Before using A third option is leasing the devices from a third
an NPWT device for patient treatment, a simple party or from the manufacturer. The choice to
registration form is filled out and sent to the supplier not sell the machines, but rather to rent them,
by fax or email. After use, the device is checked out is a peculiar feature of the NPWT treatment,
following the same procedure. which puts it more on the side of rehabilitative
technologies (i.e. magnetic fields) than dressings
Another option is to order the device directly from and medications.582 When the NPWT devices are
the supplier via phone or the internet. However, leased, the maintenance responsibility lies with the
this method has the drawback that the device manufacturer or the third party.
cannot be used right away because it has to be
delivered first. Hospitals can also purchase NPWT Free rental model
devices from the manufacturer, but if they do, they In this model, the NPWT device is rented and
will also have to manage possible device repairs, if the disposables (the canisters and dressings) are
required. The hospital billing system in place in the bought. This has been particularly effective in
respective countries provides for the corresponding markets where the introduction of the treatment
remuneration for the service provided. is slow. The free rental business model is becoming
more common in Scandinavia and the UK and is
In Sweden different options are available: purchase, well established in southern Europe.
lease or rent. It is the choice of the individual
health-care facility and often dependent on public Disposable devices
procurement in different counties. Disposable units are bought by the health-care
provider and discarded after treatment. It is
The preparation of the device for re-use also expected that health-care providers who do not
follows the hospital’s respective approach to the have a leasing contract with the companies but
organisation of NPWT. Hospitals maintaining a simply buy the devices will lead to an increase in
device depot or owning their own devices prepare the actual use of NPWT and consequently to a
the pumps by wipe disinfection after every patient lowering of the tariffs both for the disposable and
according to the manufacturer’s specifications. If for the non-disposable devices.583
the devices are provided by the manufacturer, the
manufacturer will take care of regularly checking Managed service
both software and device. Another way of organising the handling of devices
and auxiliary equipment is using a managed
In an ambulatory setting, patients are either service delivering all wound treatment including
provided with a device directly by the NPWT.584 It has been suggested that such a setup
manufacturer or through a home care provider. In might optimally help ensure consistent, high-
this case, the patient, and the attending physician quality patient care, with sufficient flexibility
and caretakers definitely need a contact person to meet the needs of individual patients and
to help them with possible device malfunctions which also be effective in providing cost-effective
or complications. Upon termination of NPWT treatment across different healthcare settings.
treatment, the device will be picked up and
prepared for re-use by the home care supplier or Optimally, the use of a managed service may give
the manufacturer’s service staff. the following advantages (adapted from Williams):584
• Uses a centralised system for rental, maintenance whereas the contact person assigned to treatment
and purchasing—reduction in rental costs; single and dressing questions should have undergone
maintenance contract paid quarterly and known specific NPWT training (typically a specialised
in advance; reduced waste with all consumables nurse or a doctor).
purchased from one supplier
In the UK, specific training in NPWT varies by
• Produces accurate records, including numbers of location. In general, the tissue viability team will
patients treated, speciality, wound type, length provide both theoretical and practical training,
of treatment and outcome often supported by company representatives
from the chosen local system provider. This will
• Eliminates delay in treatment highlight local guidelines for the use of NPWT.
There are no specific UK NPWT qualifications,
• Makes transition from secondary to community and nurses would be expected to act within their
care seamless, with more patients being treated national code of practice.
at home
In Sweden, the health-care provider has all medical
• Reduces inappropriate use by limiting responsibility for the patient´s care. Companies,
authorisation to those who are experienced and however, must provide technical support, which
knowledgeable in the use of NPWT is contracted in the public procurement. The
responsibility for service of the devices is clarified
• Enables technological advances in products to in the public procurement and is either performed
be implemented effectively (i.e. replacement of by the companies or by the department of medical
older units with newer models) technicians at the different hospitals.
• Supports integration of all wound treatment Service support with regard to the patient
options in addition to NPWT It is crucial that the patient be informed about
which steps to take if there is a problem with
the treatment—for example pain, pressure level,
Service support leakage—and is able to carry them out. The patient
How can continuous high-quality treatment should be informed about the relevant steps at
be guaranteed? discharge from the hospital preferably with a
Whenever a decision is made to continue the relative or support person. However, it is still
patient’s treatment in an ambulatory setting, it is important that the patient be able to get support
important to name one or more contact persons over the telephone in the case of a malfunction, an
that the patient or the carers and the attending alarm or if the seal is breached. This is particularly
physician can contact if questions or problems important when taking the patient population into
arise. Different contact persons should be named consideration, which predominantly consists of
for device-related issues and questions concerning elderly patients,19 who might not be very familiar
the NPWT treatment and dressing. with technology. Therefore, if 24-hour telephone
support from the manufacturer and/or the
In Germany, the individual responsible for any caregiver is not available, a telephone hotline to a
questions related to the treatment unit is usually section of the prescribing hospital/outpatient clinic
a service employee of the respective company, manned around the clock is advisable.
Responsibility One of the basic prerequisites for a well-working
Responsibilities regarding NPWT also have to be patient care network is good communication
clearly defined for the entire duration of treatment among all parties involved. That is the only way
and should be emphasised in the education that continuous patient treatment be guaranteed.
of staff. In the hospital, this is fairly simple.
Responsibility lies with the attending physician In the UK, there is no specific patient or carer
who can then delegate NPWT changes to specially network for the support of patients receiving
trained staff, if required. NPWT either in a hospital or community setting.
It is recommended that patients and/or carers
In the non-hospital setting, regardless of whether should, when receiving NPWT in a home care
the patient is to be treated in home care or situation, be provided with appropriate supporting
primary care, responsibilities need to be clearly literature and basic training in the management of
defined before discharge. In Germany, the main the dressing and the equipment.
responsibility also lies with the supervising
physician who should be trained in NPWT. In Sweden the patients should get information
on whom to turn to during treatment at home.
In Sweden the overall medical responsibility for the This has, however, been a major problem
patient’s care and for the NPWT treatment is with for patients with the result they often feel
the physician who has initiated the treatment, even abandoned by health professionals and left to
when the dressing changes are done by primary care. manage the treatment on their own.566 In Sweden
If the district physician has initiated the treatment there is no formal requirement that personnel
the responsibility is with primary care. should have specialised education in wound
care before initiating or treating patients with
Education and providing a network NPWT. The knowledge and competence of health
supporting the patient professionals may therefore vary and are often
If therapy is to be continued in an ambulatory dependent on the individual’s experience and
setting, a suitable network for ideal patient care in interest. It is, however, only physicians who have
that setting should be drawn up before initiating the right to prescribe the treatment, but it is most
NPWT in the hospital. In Germany, so-called often managed by nurses.
wound networks consisting of members working
in all three settings have been established in Minimum requirements for staff education
several regions. These organisations can facilitate To ensure that scientific evidence is carried
a well-managed transition of the patient from the into daily clinical practice, there is a need for
inpatient to the ambulatory setting. a knowledge transfer model that articulates
an educational plan for the various levels of
This approach requires a case manager who has professional development.585 The staff education
an overview of the current status of treatment should highlight the challenges and potential
and, if necessary, can organise a visit to the solutions to integrate NPWT into a seamless
attending physician. The case manager is aware continuum of care including a community-
of the duration of treatment and, if required, can based patient care model. The education
challenge the remaining duration of NPWT. While, should include the basic concepts of tissue
useful, wound networks with case managers are far debridement, infection/inflammation control
from being established in all regions of Germany. and moisture balance. Staff should also be trained
to understand the basic principles of pump and • After discharge, who will perform dressing
dressings and to be able to take appropriate changes—the hospital, home care, primary care?
measures if necessary.
• Who supplies dressing kits and devices?
Questions to be considered before
initiating therapy • What is the intended duration of treatment?
Regardless of whether the treatment is to take
place in the home care, primary care or hospital • Does the patient back the decision to perform
setting, the following questions should be NPWT? If so, what are the prerequisites?
answered before initiating therapy: 371,486
• Does the patient consent to the treatment and is

• Is it possible to effectively debride the wound adherence expected?
bed and wound before applying NPWT?
• Is communication between parties secured and
• Can NPWT be used based on the results of well described with each other: GP/surgeon,
wound assessment? attending nursing service, home care supplier
and hospital?
• Can or will the patient’s symptoms be improved
with NPWT? The high drop-out rates in the literature163,578
suggest that the adherence and outcome of the
• Are there contraindications to NPWT (Chapter 5)? treatment is more related to the staff competence,
choice of patient and wound, than to the
• What are the treatment goals to be achieved technology itself. This underlines the need for a
through NPWT—preparation for secondary suture, coherent academic training programme for staff
wound preparation, exudate management? working with NPWT.
8. Documentation,
communication
and patient safety from the
medico-legal perspective
NPWT is an increasingly common form of demonstrated both the significant cost benefits
wound management applied to patients with a and improved outcomes that such a shift in
variety of complex wounds. These patients often care delivery location can bring. Moffat et al.586
move through the care system, receiving care highlighted the potential emotional impact that
from multiple agencies working across service home NPWT may have on both the individual
boundaries. This development raises an increased and the family but found an overall benefit to
awareness of the need for documentation, home NPWT provided that there was thorough
communication and patient safety, particularly discharge planning, good service co-ordination
from the medico-legal perspective. and communication. When discussing the impact
of medical support in the home Teot comments :
Implications of cross-sectional ‘The relatively low interest of wounds for many
NPWT doctors can create problems in term of medico-legal

consequences and may lead to over cautiousness in
A substantial challenge for out-of-hospital terms of decision making.’587
treatment with NPWT is the patient population
(comorbidity, capacity for adherence) as well as To overcome the barriers to introducing NPWT
the experience and skill of the staff, particularly in out-patient facilities, it is essential that the
in an environment without continuous rationale for initiating NPWT as well as the
observation of the patient. As a consequence, responsibility for the treatment be clearly defined
the cross-sectional use has implications for both for the entire duration of treatment. Thus,
the delivery and acceptance of NPWT in an out- introduction and acceptance of NPWT in those
of-hospital facility (primary care, out-patient settings requires careful discharge planning with
facility, patient’s home). Increasing use of NPWT ‘transitional’ protocols and support in place if
has seen a progressive move to deliver therapy care is to be delivered safely, cost-effectively and
in a home care situation. Dowsett et al.278 have without interrupting therapy between care settings.
Guy and Grothier370 have developed a suggested tests such as magnetic resonance imaging,
community NPWT pathway, which supports the when equipment such as the pump has to be
patient and the care team through the discharge disconnected for a variable period of time.
process. Similar locality-based care pathways should Most manufacturers suggest that therapy can
be developed to facilitate smooth care transition.584 be discontinued for up to two hours before a
dressing must be replaced.
These protocols need to address:
• Communication between care teams and Off-label use

organisations with: Although the basic principles are the same, the
— Agreed equipment strategy and documentation success of NPWT has resulted in an explosion
— Co-ordinated ordering of pump systems and of devices, wound fillers and drainage kits with
consumables different therapy characteristics and operating
— Ongoing follow-up arrangements instructions. More than 25 FDA Class II approved
NPWT devices were available commercially in
• Contingency plan for equipment shortages 2014. Devices can now be mains, battery or
and failures mechanical powered. They have a variety of
—Additional equipment rental agreements and drainage tubes and offer a range of collection
funding streams system volumes designed to accommodate
different wound types, sizes, positions and
• Out-of-area transfers exudate levels. In addition, the wound contact
—Continuity of care when different or no NPWT layer may be gauze or a variety of foams. Each
systems are supported/funded manufacturer has designed components as part of
an integrated and regulatory framework-approved
• Equipment returns and decontamination system and only within each system can negative
pressure profile and wound interphase pressure
• Clinical incidents, training, monitoring and be relied upon. This means that component parts
review procedures from different manufacturers should not be built
—Learning across organisations and boundaries. into a self-assembled NPWT system and that
the disposables are not interchangeable. To use
Protocols need to address not only issues related unmatched components in such a way represents
to patients, in a care facility or their own home off-licence usage. Complications resulting from
but also how patients will be seen and assessed such actions are, therefore, the sole responsibility
in out-patients or a general practice surgery and of the individual and institution/provider and
how NPWT will be managed during diagnostic not of the manufacturer.
Contractual terms Notably, indications for use and application
and agreements methods are not the same for all devices.
Health professionals need also to be aware of the Treating complex wounds, particularly with
local contractual arrangement, and terms and high-tech strategies, carries with it the risk
conditions established with the chosen provider of treatment complications. Cases have been
of NPWT systems and components. This will reported that highlight the danger of NPWT close
vary between suppliers and may differ between to exposed viscera and blood vessels. In an FDA
purchased and leased items. Contracts should preliminary public health notification,588 bleeding
specify arrangement for equipment maintenance, was identified as the most serious complication
cleaning and sterilisation schedules and identify occurring in 6 deaths and in 77 injuries.
lines of responsibility both during and between Following these and other NPWT treatment
patient care episodes. complications, the FDA has put forward a number
of recommendations and precautions in relation to
this form of therapy. These can be summarised as:
Patient safety issues
Reports regarding adverse reactions in the treatment • Careful patient selection, especially in relation to
of patient with NPWT indicate the need for clear wound type
instruction to the staff as well as the patient, with
regards to patient safety issues. This is illustrated by • Selection of the appropriate care setting for high-
the Pennsylvania Patient Safety Reporting System577 risk patients
which highlighted a number of patient safety issues
in relation to NPWT, although some of these issues • Wound-care and appliance-specific
related to general poor wound assessment and considerations
documentation. It found:
• Documentation and communication
• Inadequate or lacking assessment (5 %)
• Training of health professionals, patients and
• Delayed or incorrect application (21 %) carers.
• Inadequate monitoring and ongoing assessment

(47 %) Patient safety checklist for out-
patient NPWT
• Discharge issues (7 %)
—carer/patient education An area that is considered critical when NPWT
is used in an out-patient situation is training for
• Other events (20 %). patients and caregivers. Patients and carers should
know how to:
Martindell,577 in her review of the Pennsylvania
Patient Safety report, comments on the vast • Safely operate device
number of NPWT systems available and stated —Provide device-specific information
that a nurse caring for a patient using NPWT must
be familiar with the manufacturer’s instructions. • Respond to alarms
—Deal with seal leaks • Helps it to:
—improve accountability
• Change dressing or downgrade to a ‘normal’ —identify risks, enabling early detection of
dressing complications
—Ensure dressing material is available on site —address complaints or legal processes.
• Recognise complications
—Bleeding Documentation
A number of authors have highlighted failings
• Respond to emergencies in nursing and medical records, including
—Stop NPWT records associated with wound care and PU
—Apply direct pressure management.591–593 Medical and nursing notes
—Activate emergency services form part of a legal record and can be an
important piece of evidence. As such, notes must
• Contact support be thorough, accurate, factual, objective, legible
and free from abbreviations unless these are
defined. They should also be contemporaneous
Communication and truthful, signed, timed and dated. When
One common theme throughout these detailing wounds, particularly cavity wounds,
recommendations is that communication both hand-written notes can usefully be supplemented
among health professionals and between health with orientated ‘scaled’ diagrams, maps and
professionals and patient must be robust if NPWT is photographs.594 Accurate and detailed cavity
to be delivered safely and effectively. Documentation wound documentation is particularly important,
serves a number of purposes by:589,590 if the danger of retained dressing material is to be
avoided. Notes should record:
• Promoting better communication and sharing
of information among members of the multi- • The wound packing material(s)
professional health-care team —Material type
—Size
• Making continuity of care easier —Number
—Location
• Showing how decisions related to patient care
were made • If used, number and type of wound bed contact
layers.
• Providing documentary evidence of services
delivered The written description should be combined with
a diagram illustrating the relationship of the
• Supporting: packing material to the wound, recording where
—Delivery of services packing extends into undermined areas and
—Effective clinical judgments and decisions therefore may not be visible at the next dressing
—Patient care and communications change. Packing material and wound filler should
—Clinical audit, research, allocation of resources be counted in and out and action should be
and performance planning taken if any discrepancy is noted. There have
been reports of adverse events related to materials • Training and staff/care-system response
and wound fillers. 595,596
• Communication and documentation
Legal and litigation issues • Skin/pressure damage related to tubing and poor
Legal proceedings involving NPWT are dressing technique.
increasing.19 Risk reduction requires understanding
contraindications for use and early recognition of The complex nature of some wounds may mean that
potential complications of NPWT and, as such, care is experimental (e.g. vascular surgery and groin
exposes the inexperienced user to greater risk. 19
infections) and the use of NPWT in such cases may
Legal and litigation issues in relation to NPWT can extend outside of the manufacturer guidelines and
be divided into the following areas: breach rules on contraindications to therapy. In such
cases a full explanation of the care decisions must be
• Retained dressing material recorded, including recognition of off-licence usage
and the patient’s permission for such care. Care must
• Failure to respond to alarms be closely monitored and only undertaken by health
professionals experienced in the use of NPWT.
• Failure to follow manufacturer guidelines
—Pressure settings/off suction duration In summary, the use of NPWT is not only an issue
—Dressing intervals with regard to technology and wound treatment
but also represents a fundamental change in terms
• Inappropriate case selection/assessment of the legal aspects and patient safety issues in the
—Failure to respond to bleeding high-tech treatment of wounds.
9. Health economics
The introduction of NPWT represents an of dressing changes, total time to healing and
innovation not only from a clinical perspective, QoL.15 A correct wound diagnosis is a prerequisite
but also with regard to health economics, for accurate and successful care, the use of more
organisation resource use. This novel form of effective dressings and wound care material, choice
wound management is differentiated from the of dressings suitable to type of ulcer and diagnosis,
existing approaches by increased demands for measures to improve healing and avoid recurrent
a clear definition and interpretation of resource ulcers, and shortening of total time to healing.15–17
use and cost-effectiveness. This applies both to
the management of closed incisions, complex,
and in hard-to-heal wounds.597–599 To understand Organisation of care
the potential impact of NPWT, there is a need When dealing with health economic analyses and
to recognise the challenges in the analysis of resource use in complex wounds, with regards
resource use and economic cost in the treatment to NPWT technology, it is essential to look at its
of wounds. 15
impact on organisation of care both in-hospital
and when used across sectors.
A major problem in the analysis of the cost of
disease states is that comparisons of cost analyses It is less common to study and evaluate
are compounded by variations in care protocols organisation of wound care or management
and the economic status of different countries, for systems but these studies can provide important
example, variations in rates of pay for health-care and useful information to improve the outcome
staff and reimbursement. of wound care. It is also important to be aware of
costs associated with non-optimal management
There is an increasing demand for quality outcome of complex wounds, particularly in cases with
data to support the economic decision-making cross sectional care. The economic impact of
process, which turns our attention to resource use organisation of care and the consequences of the
efficiency and assessment of consequence rather lack of coordination between various disciplines
than simplistic cost arguments, particularly in and levels of care, as has been illustrated in reports
post surgical wounds, PUs, lower LUs and DFUs.15 with regards to management of DFUs.600–603
The current models of care are often fragmented
in their delivery and reflect exclusively on These findings have been confirmed in various
intervention versus cost over time. countries and health-care systems globally indicating
the danger with regard to fragmented care and lack
Successful projects are often associated with a broader of communication between care-givers.604–614
perspective including not only the costs of dressings
and material but also costs of staff, frequency Many health economic studies in hard-to-heal
wounds have been focused on reduction in in- Technologies in the treatment
hospital stay and treatment at hospital-based
specialist clinics. However, a substantial number
of wounds
of resources are used in outpatient facilities in When NPWT was introduced, health economics
primary care/home care. The finding that home
19
analyses were focused on in-hospital treatment.
health-care accounts for a significant proportion of However, when used across sectors, in out-
the resources spent in the treatment of individuals patient facilities, primary care and home care,
with hard-to-heal wounds indicates that the trend the challenge was to understand the impact
towards high-quality care based in outpatient of NPWT as a device or a service adapted on
clinics and home care is and will be of major a broader view, particularly, since NPWT was
importance. A substantial number of studies initially considered expensive, demanding
indicate the importance of organisation in wound and time consuming, Health economics
care, as well as coordination of treatment strategies reports concerning dressings were evaluated
to achieve an optimal care with regard to both to determine if they resulted in less frequent
outcome and cost. dressing changes or in faster healing.15,615,616
When assessing use of resources, it is important

Factors related to healing of not to focus on individual items such as
hard-to-heal wounds dressings or procedures but to adopt a broader

view of total resource use. Few studies in wound
NPWT is introduced as a technique or a service care provide a full cost-effectiveness analysis.15,616
in the treatment of wounds more related to the Most studies focus on clinical outcomes only
condition of the wounds than to the aetiology of and include analysis of the estimated direct
the wound. Currently the majority of studies in medical costs of treating wounds but not indirect
wound management are performed based on the costs relating to loss of productivity, individual
aetiology of the wound. The challenge in all these patients’ and family costs and loss of QoL.15–17
studies and particularly in NPWT is to recognise
and control for heterogeneity in individual states Costing is a two-stage process. The first stage is
and confounding factors as well as variation to measure the quantities of resources used,15,17
in type, site and condition of wounds. The and the second is to value those resources. In an
distinctive feature of an economic approach to analysis of RCTs in hard-to-heal ulcers published
the evaluation of health-care interventions is after 200315 it was found that cost and resource
that it involves explicit consideration of both use was used as an endpoint in 4.5 % (of the total
the costs and the outcomes or consequences number of endpoints registered). This could be in
of an intervention. As a consequence a health the shape of economic costs related to healing,
economic analysis relies heavily on adequate institutional costs, cost per week, resources used,
information regarding comorbidity and basic number of dressing changes, cost savings or costs
standard of care as well as the natural outcome. per patient per year. Most of these cases were
Today there is a substantial limitation regarding primarily descriptive and there were concerns
large cohort studies following patients to healing regarding items included, the perspective of
and identifying factors related to outcome and study and lack of distinction between resources
resource use. used, costs and charges.15,19,605,609–611,614,617–619
Comparing treatment resources included in addition to cost items which
interventions further complicate comparisons.15,602,603,616
To get approval to introduce a new treatment Modelling studies

strategy, it will be mandatory to present evidence An alternative to evaluations based on results from
including health economics, which compares the cohort studies and RCTs is to perform modelling
existing standard treatment with a new treatment studies with the application of data from different
alternative, particularly in the case of a technology sources. There are some modelling studies
like NPWT. For this reason there is an increasing performed with regards to NPWT, particularly in
need for valid cost and resource-use studies. At the area of DFUs.164,622–629 This type of study does
the moment there are few high-quality studies not differ from above mentioned health economic
with regard to wound management and there analyses regarding the demand for costs being
is confusion as to how these studies should be considered in relation to outcome. Modelling
performed, especially with regard to endpoints and is often an option when the perspective of an
resource use.15 There is a limited number of health intervention covers a long period of time.611,612,620
economic studies on NPWT (appendix 12 and 13),
and particularly with regard to cost-effectiveness. Controversies regarding health
economic evaluations
Cost-effectiveness studies The number of health economic studies of
Cost-effective analyses are commonly used, the treatment of wounds is limited and most
sometimes misused in referring to all types frequently based on non-comparative case studies
of economic evaluation in health care. A few or clinical trials comparing a specific treatment
cost-effectiveness analyses or full economic or strategy for a specific period of time.15–17,602,616
evaluations of treatment alternatives for hard- The same pattern can be seen with regard to
to-heal and post surgical wounds have been NPWT (appendix 12 and 13). From an economic
performed according to those methodological perspective these studies create a substantial
demands.620,621 Many published reports supply challenge since the actually only measure the
data without simultaneous consideration of resources used in a clinical trial based on a specific
outcome or consequences. These studies can premeditated clinical protocol. One concern is
primarily be interpreted as some sort of cost of external validity—how much daily practice differs
illness or cost identification analyses and can from the environment in a trial setting and if all
provide valuable information for policy makers or patients are followed to a specific end point or just
supply data for planning and execution of future for a short observation period.
economic evaluations.
One challenge regarding NPWT is to evaluate the
Cost-effectiveness studies incorporates both cost cost of the technology or service from a broader
and effect. The advantage of these analyses is they perspective. Product costs frequently have been
consider the possibility of improved outcomes considered to be synonymous with the cost of
in exchange for the use of more resources. Cost- care.15 However, the purchase price of dressings
benefit analyses includes a decision about whether or technologies rarely forms a significant fraction
the cost is worth the benefit by measuring in of the actual cost of care. These costs are often
monetary terms.15 Many studies contain different negligible in comparison with other factors such
as costs associated with frequency of dressing of the effectiveness of the treatment which widely
changes, nursing time, effectiveness in relation depends on which outcomes are adopted; wound
to time-to-heal, quality of healing (avoidance closure, wound bed prepared for grafting or
of wound recurrence), ability to return to paid amputations avoided.630,631
employment and the cost of the care setting. Cost-
cutting exercises that focus on the use of less costly Components of costs
dressings or technologies might, for example, Costs are also difficult to determine because their
result in higher overall costs if dressing change composition vary. The calculation can be determined
frequency is increased (necessitating increased by service costs, but could also include staff hours,
nursing time) and time-to-heal is extended. In materials, dressing changes as well as in-hospital days
some studies evaluating NPWT, in out-patient and potential adverse events.632,633
settings, the finding is that you achieve a reduction
in the use of staff due to less frequent dressing When investigating the health economic aspects
changes (appendix 12 and 13). of NPWT it should be taken into account that the
treatment marks a major shift in terms of patient-
Health economics and reimbursement and wound care, particularly for extensive complex
with regard to wounds acute wounds, postsurgical wounds and chronic
The health economic analyses with regards to wounds for both in- and out-hospital patients. It
wound treatment and various technologies are has changed the way caregivers treat wounds and
very sensitive for the influence of reimbursement introduced new variables in the system. Where
and from which perspective the analysis is done, conventional wound management is centred
i.e. payers perspective or societal perspective. The around repetitive and frequent dressing changes,
influence of reimbursement has been discussed in NPWT demands less frequent but more complex
chapter 7 on the organisation of care. and time consuming dressing changes. Hence, by
introducing NPWT, work and resources are shifted
from one activity to another rather than decreasing
Wounds treated with NPWT the overall time consumption.634
Cost-effectivness
Determining the cost-effectiveness of NPWT In this section we focus on some of the most
is a challenging task, particularly when relevant aspects related to resource use, economic
considering the treatment’s impact on wound cost and cost-effectiveness of NPWT by using the
management, organisation, competence of available evidence to give the readers a systematic
staff and reimbursement. This complexity of view of the health economic aspect of this therapy
influencing factors complicates the decision on
which costs to include in the calculation and how
to perform cost-effectiveness analysis. Should, Evaluation of comparative
for example, cost be derived from cost per day,
and non-comparative studies:
cost per treatment or cost per wound treated.
Furthermore, if the treatment is provided via resource use
rented devices, should the calculation be based and economic cost
on the service package adapted to the number of In a systematic search (PubMed, CINAHL, Scopus,
devices rented or the cost of a single machine per Web of Science and manually) 270 studies and
treatment? The same applies for the investigation reviews were identified and abstracts obtained
with regard to health economics and resource use The most common results from studies in favour
in the treatment of wounds with NPWT. Based of NPWT is that it aids a faster healing rate than
on an initial evaluation, 176 of these papers other wound healing therapies, and that the shorter
were excluded, and following a detailed analysis healing time brings the overall costs down to a cost-
another 15 papers were excluded (no original effective level even though NPWT is typically a more
health economic/cost data provided, results not expensive measured per dressing. Regarding complex
reported properly/did not appear which costs were postsurgical or extensive acute wounds a reduction
associated specifically with NPWT treatment, lack of in hospital stay is frequently reported
of the relevant parameters) (appendix 14).
Other studies report that the timing of the
Included in the evaluation were 48 studies, 39 were treatment matters, so that early treatment is more
comparative and 9 non-comparative (appendix cost-effective than late, that non-commercial
12; 39 studies,2,164,250,280,284,395,422,446,489, 622–629,632,635–655 NPWT-systems prove to be cost-effective compared
and appendix 13; 9 studies). 11,20,634,656–661
The with commercial ones, and that mobile NPWT-
comparative studies include 14 RCTs,250,280,284,395,422,446, devices for use in home care settings seems to be a
635,636,639,641–643,650,652
12 cohort studies,632,637,638,640,644,646, cost-effective (and patient convenient) solution.
648,649,651,653–655
4 case studies,2,489,645,647 and 9 modelling
studies.164,622–629 The number of patients in the RCTs NPWT in chronic wounds
were 16–324, in the cohort 10–13,556 (one claims In nine studies including chronic ulcers/LUs/PUs
data from a database), in the case studies 7–20, in four were in favour of NPWT, four were neutral
the modelling studies 82–1721. The comparative and one in favour of a comparative treatment
studies included surgical/postsurgical wounds (n=8), with regard to resources spent or economic cost.
diabetes related wounds (n=8), acute or traumatic In addition the studies of hard-to-heal or non-
wounds (n=5) chronic ulcers/LUs/PUs (n=9), healing ulcers of various aetiologies four were in
various/mixed/miscellaneous ulcers (n=8). There favour and four were considered cost neutral with
were three comparative studies which evaluated regard to NPWT versus a comparative treatment
various NPWT techniques, the remaining (appendices 12,13). The following examples
compared with various conventional or standard address findings from our analysis addressing
treatments (dressings). chronic wounds.
Complex surgical, postsurgical wounds and Augustin and Zschocke reported a higher level
acute or traumatic wounds of QoL and satisfaction among people treated
In the eight comparative studies of patients with NPWT in a study comparing two different
with surgical or postsurgical wounds treated forms of application in a cohort of 176 patients.662
with NPWT four were favourable with regard to They emphasised how this finding would be of
resource use or economic cost, two were neutral importance when the decision of which treatment
and two were unfavourable. to choose for the patients, would be made
according to the principle:
In the five studies of patients with acute or
traumatic wounds one was in favour for NPWT, ‘no decision about me without me.’662
one was neutral and three were negative with
regard to resources spent or economic cost Braakenburg et al. comparing NPWT with
compared with other treatment strategies. dressings in a RCT demonstrated how NPWT was
associated with better efficacy parameters also with diabetes, six are in favour of NPWT, one
with a better cost/effectiveness ratio, mainly due was considered neutral and one in favour of an
to the reduction in the times of application of the alternative treatment with regard to resource use
devices and the less frequent changes that allowed and or economic cost. It has to be recognised
a sparing of the resources use per patient.663 that the studies with the most impressive
outcome with regard to resources spent and
Vuerstaek et al. in a prospective RCT comparing economic cost were US studies including foot
NPWT and dressings in chronic wounds, reported ulcers following surgery (revision/resection) or
faster healing in the NPWT group. 664 Furthermore, minor amputations.9,10
a more favourable economic profile due to faster
healing, which was associated with a reduced length Apelqvist et al. in a prospective RCT on NPWT
of hospitalisation and a global reduction in costs.664 versus moist dressings in post-amputation
wounds, demonstrated superiority of NPWT
Abotts et al. and Dowsett et al. both concluded, when number of procedures, dressing changes
after prospective studies, that the home use and outpatient visits were considered. 3 Despite
of NPWT significantly reduced the costs by not observing any difference in number of
reducing the hospital related treatment.278,574 admissions or length of stay between the groups;
Since patients were earlier and more frequently they demonstrated a significant reduction
discharged from hospital and managed on in resources and costs in the NPWT group,
a outpatient basis, there was a considerable considering both the cost per treatment and the
reduction of resources consumption.278,574 cost to achieve healing.3 Similar results were
produced by Driver and Blume in a retrospective
The data for ulcerations, PUs, VLUs and analysis of patients enrolled in a RCT comparing
postsurgical wounds, are still sparse or, when NPWT with moist dressings over a 12-week
available, ambiguous.640,646,650 However, a review by treatment course.642 Here, NPWT proved to be
Searle and Milne concluded that there is enough more cost-effective than standard care, mainly
evidence showing the cost-effectiveness of NPWT due to a reduction in health-care resources. The
compared with standard treatment.634 authors calculated that the costs for closing 1 cm2
hard-to-heal-wound was 100 % higher in standard
The main reason data is unavailable is because care than when treated with NPWT.642
good-quality prospective studies in this field have
not been conducted. Dumville et al. came to Despite these and other studies, that indicate
the same conclusions in three Cochrane reviews the value of NPWT with regard to resource use
on LUs, PUs and surgical wounds left to heal by and cost in complex wounds in individuals with
secondary intent. No evidence is available for diabetes, there is a reluctance in accepting NPWT
addressing cost-effectiveness of NPWT in each of as a cost-effective therapy for DFU, which might
these indications.12,13,421 be explained by NPWT in comparison with the
existing standards, was considered costly and
NPWT in diabetic foot ulcers not so user-friendly.666,667 This is probably one
DFU was probably the first field using NPWT in reason why NPWT in the literature is still not
which data on cost-effectiveness were available, considered to have demonstrated enough
coming both from retrospective and prospective evidence to be considered a valuably strategy in
trials.665 In eight studies of DFUs in individuals managing DFUs.14,21,668
General findings that are included in the evaluations, even within
The number of indications and clinical protocols the category of ‘direct costs’. Widely used are
for NPWT challenges the defining criteria by which length of hospital stay, cost of labour, cost of
to evaluate NPWT from an economical point of materials and total costs. But these are far from
view. However, there were transversal items used in represented in every evaluation, and it is seldom
most of the studies which included integration of clearly stated exactly what each type of cost
healing rates and healing times with cost per day measurement contains, total cost being the most
of treatment, days of admission reduced by transfer comprehensive and thus problematic to compare
to community care, the avoided surgical revisions, without clear specifications. Various endpoints
recurrences, readmissions and infections deducted are used or not defined. Some studies conclude
from the number of events.669 on niche parameters such as antibiotic usage,
charges to facilities or material rental fees, while
This shift from efficacy to resource use and others evaluate in far less detail. Parameters in the
economic cost to achieve an outcome was category of ‘intangible costs’ such as pain is mostly
prompted by the need to demonstrate superiority seen in the RCTs.
of the novel treatment, which in comparison with
the existing standards was considered costly and The consequence of these findings are that the
not as user-friendly. 666,667
results from most of these studies has to be
interpreted with caution and put in the perspective
The economy of NPWT is still debated, since from which environment , type of patient/ulcer
little high-quality data are available. Due to this (study population), health-care and reimbursement
gap, the reviews and guidelines do not give solid system they have been performed.
assessments on the cost-effectiveness. Despite
a certain level of agreement between resource A paradigm shift in NPWT: inpatient to
reduction and the reduction of in hospital stay, outpatient care, a service to a product
staff hours per treatment are expected to be stable There is a shift in the application of NPWT
irrespectively of these circumstances. from an in-hospital services, provided by highly
specialised units, particularly in postsurgical
It has to be recognised that the impact on resource wounds to an outpatient management strategy,
use and economic cost with regard to the use and which, after the prescription that is mainly done
indications of NPWT in patients with surgical during hospital admission, is carried on by visiting
wounds and chronic wounds is more complex nurses on outpatient basis.650,670 This shift toward
than just healing rate and time-to-heal. NPWT an increasing ambulatory use of NPWT is closely
impacts on health-care organisations and calls connected to the introduction of disposable
for relevant adaptation in terms of competence devices.164 This has led to a considerable reduction
of staff, in- and out patient organisation and of costs per treatment, which can now be integrated
updated reimbursement system and illustrates the in different phases of the complex therapeutic
transformation in wound care from passive topical strategy of the patients, as a complement to other
treatment to an era of complex treatment modalities. options such as hyperbaric oxygen therapy, surgery,
dressings, medical therapy, grafting.671,672
Methodological considerations It is suggested that this could increase the use

There is a remarkable variation in the parameters of NPWT and the number of its indications and
applications, reducing constraints of the service effectiveness evaluations done so far should be
and costs to an extent that could be affordable also integrated with the new information coming from
for low-complexity chronic wounds, not only for the developments in the management of acute and
the major pathologies.278,585 In this scenario, cost/ surgical wounds as well as chronic wounds.139
10. Future perspectives
In this final chapter of the document we aim This permits the widespread adoption of single-
to reflect on where technological developments use devices in the emerging prophylactic use of
within NPWT seem to be going and continue NPWT to reduce complications, such as dehiscence
to discuss some of the main clinical and or infection, when used over closed surgical
organisational aspects that can be expected to incisions.383,677 In addition, single-use devices do
influence future spread and uptake of NPWT in not restrict patient mobility as they are small in
clinical practice. dimension and self-contained.
New material for wound fillers

Technological developments The properties of the wound dressing or wound
Technological advances within NPWT are currently interface determine most of the effects of NPWT
seen to be heading in several directions. on the wound bed.
Hospital-based system with increased The currently used wound fillers are commonly
sophistication foam or gauze. The interaction between the wound
Hospital-based devices are developing in the dressing and the wound bed has been described
direction of increased sophistication and delivery in detail for foam and gauze.57 Both these wound
of adjunct therapies such as saline irrigation/ fillers have a mechanical effect on the wound. The
instillation, either intermittently or continuously tissue surface is stimulated by the structure of the
with NPWT.43,495,504,673 The benefits of powerful wound dressing. This will trigger the cells to divide
antimicrobial solutions for wounds with a high to rebuild and strengthen the tissue. The amount
bioburden are under intense investigation. 462,474,497
and character of granulation tissue formed may
In another related direction, the delivery of differ between the two dressings. The use of foam
alternative active substances such as insulin508 or as a wound interface in NPWT produces thick,
doxycycline506 are being investigated, as yet on a hypertrophic granulation tissue. Gauze under NPWT
non-commercial (off-label-use) basis. results in less thick but dense granulation tissue.57,678
Simplified single use devices There are other difference in properties between
There is a substantial development, almost as foam and gauze in that the porous structure of
it were in the opposite direction, in the use of foam allows greater volume reduction under
simplified single-use NPWT devices.163,382,403,530,674–676 pressure. The effect on the wound is also
This development, which includes both dependent on the size of the foam or amount of
electrically-powered and mechanically-powered gauze filler, for example, a higher tissue pressure
devices, recognises the benefits of the accessibility is achieved by a small foam filler compared with a
of NPWT ‘off-the-shelf’ and with a lower cost base. large foam filler.184
In the instances when the wound bed is covered therapy.679,680 The use of sensors and remote
by a wound contact layer, the micro-deformational communication facilities hold potential benefits
effect is lessened compared with when the foam and it is stated to be able to increase the quality of
or gauze is in direct contact with the wound bed, care delivered, reduce costs and improve access to
which will affect granulation tissue formation. specialised care for people living in remote places.
A novel wound filler is a bacteria- and fungus- The quality of care is improved by the availability
binding mesh. It produces a significant amount of of prompt and detailed clinical outcome data that
granulation tissue in the wound bed, more than will allow the health-care provider to define an
with gauze, without the problems of ingrowth, as optimal and timely treatment pathway and to
is the case with foam.179,186 Like gauze, bacteria- and possibly accelerate the healing of the patient.
fungus-binding mesh has the advantage of being
easy to apply to irregular and deep pocket wounds. Savings are to be achieved through the possibility
Efficient wound fluid removal in combination of taking preventive actions and avoiding acute and
with its pathogen binding properties makes severe complications due to delays in diagnosis.
hydrophobic mesh an interesting alternative
wound filler in NPWT.179,186 Better access to care is achieved for people living
in remote areas since this will allow for specialist
There are vast possibilities for further development care at a distance. The remote monitoring
of novel wound fillers and this will presumably function could also lead to better adherence in the
focus on tailoring the compressibility of the wound community care setting to the treatment prescribed
filler for altering the effect on wound contraction since deviances can be promptly discovered and
(or macro-deformation). Attempts have been made addressed. Another positive effect of these distant
to alter the pore sizes in the wound filler. There is linkages between community carers and specialist
also an opportunity for development of the surface care is the learning opportunity for community
structure of the wound filler in order to tailor the nurses achieved through ongoing feed-back from
micro-deformational effect on the wound bed, to in-hospital specialists.
hinder ingrowth in the wound filler or even to
make the dressing material resorbable. The ability to measure and collect continuous data
on the development of different wound parameters
Systems with integrated sensors also holds potential in terms of collecting BIG
for long-distance monitoring data for research due to the possibility of pooling
Next generation NPWT are devices are thought individual outcome data.
to be incorporating sensors with the ability to
continuously measure selected wound parameters This type of device holds great potential but there
and a form of basic remote communication are still some essential development challenges
capabilities. The use of different types of wound to be addressed before we can expect to see these
sensors combined with technologies that are available in clinical practice. Some of the biggest
able to analyse and process this data will make it challenges appear to be not so much related to
possible to collect, record and analyse data streams what is technologically possible, but more about
quickly and accurately over time. Hence, be able what wound parameters are the most importance
to identify the early signs of infections, specific to gather data on in order to aid wound healing.
bacteria and indicate the direction of personalised Furthermore, more research on critical thresholds
and time intervals for the measurements of these impression among the authors of the document
variables, in addition to a clearer understanding of as to what are the main issues that seem to be
how the interaction of various wound parameters affecting and influencing future uptake of NPWT.
should be interpreted, is critical to establish if the
data is to add value to clinical practice. Expanded indications
The technological developments in NPWT have
This information needs to come from clinical already led to expansions of the indications of
research and be fed into the technical developers. what types of wounds can benefit from NPWT
Once this is information is available, it seems treatment, compared with what was originally
that, despite the fact that there is still some way envisioned for devices first arriving in clinic. As
to go, most issues of a technical nature could examples, the availability of smaller, single-use
feasibly be solved.681 disposable pumps has meant that new types of
wounds can be treated (small, surgical) and in
In summary, NPWT devices could be seen as heading new settings such as short-term home care.683
in three directions: increasingly complex devices Adding to this, the new interventions underway
for specialist applications within the hospital, as described earlier may even further contribute
progressively simpler devices for lower-cost settings to the increased uptake.
such as the out-patient clinic or the home, and
sensor-based devices with remote communication Increased focus on evidence and cost
technologies to be used for distant monitoring. containment
Health-care providers are increasingly asking for
It is yet unclear as to what the ultimate proportions evidence of a treatment’s clinical effectiveness
of patients will be treated with each type of device. if they are going to provide reimbursement. In
addition to this, some health-care systems are
also starting to require health economic analysis
Changes in demand: supporting providing an economic cost calculation in favour
and constraining factors of the treatment mode.
How advanced and technological appealing a The clinical benefits of NPWT in varied wound
device might be is not the only determinant of types has been reported in over 1000 peer-reviewed
how popular a medical device will be, as several articles, and NPWT has been described as the gold
stakeholders in the health-care delivery system standard in some areas of wound care. However,
will have the potential to influence whether or not there is as yet no definitive clinical evidence
a medical device is adopted into routine care or supporting NPWT as a better and faster method for
not. Payers at various levels of the system as well wound healing than the use of advanced dressing.683
as clinicians and patients are driven by different
rationales. There are several theories and models This lack of strong evidence has several
that describe and explain the mechanisms of how explanations. NPWT is a generic multimodal
innovations diffuse into society; however, the technology that can deliver a broad range of
evidence of it is complex.682 The selected topics treatment goals depending on the patient being
highlighted here are not based on a thorough and treated and these goals can be achieved by
systematic analysis of the decisional environment altering a range of variables which all add to the
around NPWT but simply based on a general complexity of studying the therapy as part of an
RCT. The strict inclusion criteria in RCTs lead to reimbursement the issue of providing strong
recruitment problems and in turn limit real-world evidence need to be addressed.
relevance and reproducibility.683 When it comes
to cost estimations, the natural variations in Changes in organisation of care
treatment outcomes combined with variations in and community care
regimes depending on the wound type, size, and A major and general trend across health-care
amount of exudate, for example, makes it very settings around Europe is an increased move of
difficult to come up with a solid figure that can specialised health-care services from in-hospital,
be universally applied across health-care settings, ambulatory and acute health-care settings to
wound types and patients. Underlying figures of community care.
importance for such calculations such as duration
of treatment, number and frequency of dressing Length of in hospital stay decreases and patients
changes, training required, in combination with are transferred early to community care. This
great variations in pricing models offered by means that more complex and exudating wounds
the companies delivering the products are only that would previously have been managed and
examples of some of the key figures expected to taken care of by specialised staff in hospitals are
vary between each individual case. now being cared for by community care nurses in
the home setting. This in combination with the
This lack of strong evidence could potentially availability of smaller lightweight and disposable
become a hindrance for health-care providers’ devices has led to an increased use of NPWT in
access to use NPWT as health authorities and community settings. Also the development within
payers are increasingly focusing on prioritisation sensors-based systems with remote communication
and shifting of resources to treatment areas where facilities might further support introduction of
a strong clinical evidence and health economic NPWT in community care settings.
rationale can be proven.
To guarantee optimal usage of NPWT in the
This is already the case in England where ‘The community settings future emphasis must focus
National Institute for Health and Care Excellence’ on how to ensure that more nurses that do not
(NICE) is well established and in Scandinavia where have direct access to specialist health professionals
similar set ups are being discussed at political level. for expert advice are able to handle the products
Also at the level of the individual clinicians the lack correctly and are compliant to the prescribed
of evidence in some instances makes care givers treatment regimes. This requires training and
reluctant to use this mode of therapy.683 availability of reliably support systems with easy
access. If these aspects are not carefully dealt
On this background it becomes evident that the with this might impact treatment outcomes and
current problems relating to lack of high-level potentially undermine the backing of the use of
evidence supporting the clinical effectiveness of NPWT in the long run.
NPWT on different types of wounds can prove to
become be an important hindrance in terms of Also, the education of patients and caregivers
getting reimbursement for the treatment. This poses becomes even more central when treatment with
a barrier to access to the treatment. Thus, for the use NPWT shifts towards the outpatient setting. Studies
of NPWT to gain in popularity and receive backing show that patients express the need for thorough
from health-care systems in the form of continued education in managing the treatment.566,570
Therefore, it is important to educate patients and optimal treatment if perceived expensive. In some
caregivers, not only to inform them which requires cases it might not be the one having to pay for the
a structured teaching programme. Digital platforms treatment that will ripe the potential economic
and tools for self-treatment where patients and benefit of providing it.
health professionals can communicate while being
treated at home, development of telemedicine with This shift of responsibility for more specialised
NPWT is an interesting aspect for the future. care to community settings therefore calls for
a need to rethink reimbursement models and
Another important aspect of this shift to community furthermore increase pressure on safety aspects
care is the adding of yet another complex layer of and training needs.
payer structures and decision making processes.
The question about who will pay for the treatment, In the case of adoption of systems with remote
and when, will become even more complex to map monitoring facilities implementation barriers
as the answer to the question will differ according related to integration with existing electronic
to the specific setup. This complexity and unclear health records systems, changing care patterns (for
roles of responsibilities might in the end affect the example, insufficient staffing or time to monitor
patients. It may delay appropriate care and lead to and follow-up on data) and professional roles (for
reluctance between decision making levels to take example, clarify legal liability of responsibilities)
on the final responsibility of providing the most will need to be addressed to be successful.684
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Appendix
Appendix 1. (Number of search hits by search keywords (as of 31 December 2015)

Keyword Number %
‘VAC’ 1710 51.9 %
‘negative pressure wound therapy’ 862 26.2 %
‘NPWT’ 579 17.6 %
‘Vacuum assisted closure’ 254 7.7%
‘VAC therapy’ 242 7.4 %
‘V.A.C.’ 236 7.2 %
‘topical negative pressure’ 230 7.0 %
‘vacuum sealing’ 87 2.6 %
‘Topical negative pressure therapy’ 72 2.2 %
‘V.A.C. therapy’ 69 2.1 %
‘Vacuum dressing’ 34 1.0 %
‘TNP therapy’ 16 0.5 %
‘subatmospheric pressure therapy’ 11 0.3 %
‘Vacuum sealing therapy’ 3 0.1 %
‘Foam suction dressing’ 2 0.1 %
‘Sealed surface wound suction’ 0 0.0 %
Note: two different keywords may produce the same search result. The total of the search results is thus higher than the
number of citations (or 100 %).
Appendix 2. Number of articles published on NPWT in peer-reviewed journals in
the last two decades (red columns – number per year; the blue line represents the
trendline). It should be noted that the last update was made on 31 December 2015
400
350
300
250
200
150
100
50
0
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Appendix 3 All randomised controlled studies describing clinical benefit for the patient
(n=27, clear endpoint definition) and comparing NPWT versus ‘standard therapy’.
Literature search as of 31 December 2015
Year Author/country/ Group size/patient Wound type Primary endpoint
journal total/control group (abbreviation)
2000 McCallon et al/US /Ostomy 5+5 / 10 / saline-moistened Diabetic foot wounds Time to definitive closure
Wound Manage gauze (DFU)
2004 Jeschke et al./Germany/Plast 6+6 / 12 / conventional Integra integration – Skin Integra take rate, period
Reconstr Surg treatment group substitute fixation (SSF) from Integra coverage to
skin transplantation
2004 Moisidis et al/australia/Plast 10+10 / 20 / bolster Split-thickness skin graft Epithelialisation and graft
Reconstr Surg dressing fixation (STGS) quality
2006 Braakenburg et al/ 33+32 / 65 / modern Acute and chronic Wound ready for skin
Netherlands/Plast Reconstr wound dressing wounds (ALL) grafting or healing by
Surg secondary intention
2006 Llanos et al/Chile/Ann Surg 30+30 - double-masked Integration of split- Loss of STSG, area at the
/ 60 / Similar dressing but thickness skin grafts fourth postoperative day
without connection to (STSG)
negative pressure
2006 Vuerstaek et al/Netherlands 30+30 / 60 / conventional Chronic lower leg ulcer Time to complete healing
/J Vasc Surg wound care technique (LLU) (days)
2007 Armstrong et al/US/ Int 77+85 – Multicentre / 162 Diabetic foot amputation Wound size and healing
Wound J / conventional wound care wound (DFU)
technique
2007 Moues et al/Netherlands / 29+25 / 54 / Moist gauze Acute, traumatic, infected Time needed to reach ‘ready
J Plast Reconstr Aesthet therapy & chronic full-thickness for surgical therapy’
Surg wound (ALL)
Follow-up Significance Results/conclusions
in days level/tendency
/confidence
Intervals
ND Positive tendency / no Time to definitive closure in the NPWT group was achieved in 22.8 (±17.4) days,
compared with 42.8 (±32.5) days in the control group.
24 0.003 / 0.002 / no The take rate was 78 +/- 8 percent in the conventional treatment group and 98±2
percent in the fibrin/NPWT group (p<0.003).The mean period from Integra coverage
to skin transplantation was 24±3 days in the conventional treatment group but only
10±1 days in the fibrin/negative-pressure therapy group (p<0.002). ‘CONCLUSION: It is
suggested that Integra be used in combination with fibrin glue and negative-pressure therapy
to improve clinical outcomes and shorten hospital stays, with decreased risks of accompanying
complications.’
14 Positive tendency / At 2 weeks, wounds that received a NPWT had a greater degree of epithelialisation
p<0.05 / no in six cases (30%), the same degree of epithelialisation in nine cases (45%), and less
epithelialisation in five cases (25%) compared with their respective control wounds.
Graft quality following NPWT was subjectively determined to be better in 10 cases (50
percent), equivalent in seven cases (35%), and worse in three cases (15%). Although
the quantitative graft take was not significant, the qualitative graft take was found to
be significantly better with the use of NPWT (p<0.05). ‘CONCLUSION: Topical negative
pressure significantly improved the qualitative appearance of split-thickness skin grafts as
compared with standard bolster dressings.’
nD 0, (positive tendency The time to the primary endpoint with NPWT was not significantly shorter, except for
for patients with patients with cardiovascular disease and/or diabetics. ‘CONCLUSIONS: With NPWT, wound
cardiovascular disease healing is at least as fast as with modern wound dressings. Especially cardiovascular and
and/or diabetics) / no diabetic patients benefit from this therapy. The total costs of NPWT are comparable to those of
modern wound dressings, but the advantage is its comfort for patients and nursing staff.’
4 0,001 / no The median loss of the STSG in the NPWT group was 0.0cm2 versus 4.5cm2 in the
control group (p=0.001). ‘CONCLUSIONS: The use of NPWT significantly diminishes the loss
of STSG area, as well as shortens the days of hospital stay. Therefore, it should be routinely used
for these kinds of procedures.’
17 0,0001 / yes The median time to complete healing was 29 days (95% confidence interval [CI]: 25.5
to 32.5) in the V.A.C. group compared with 45 days (95% CI: 36.2 to 53.8) in the control
group (p=0.0001). ‘CONCLUSIONS: NPWT therapy should be considered as the treatment of
choice for chronic leg ulcers owing to its significant advantages in the time to complete healing
and wound bed preparation time compared with conventional wound care. Particularly during
the preparation stage, NPWT therapy appears to be superior to conventional wound care
techniques.’
112 a-0.03 / c-0.033 / no Kaplan-Meier curves demonstrated statistically significantly faster healing in the NPWT
group in both acute (p=0.030) and chronic wounds (p=0.033). ‘CONCLUSIONS: In both the
acute and the chronic wound groups, results for patients treated with NPWT were superior to
those for the patients treated with SWT.’
ND Positive tendency / no A tendency towards a shorter duration of therapy was found, which was most prominent
in late-treated wounds. ‘CONCLUSIONS: For the treatment of full-thickness wounds, vacuum
therapy has proven to be a valid wound healing modality.’
2008 Bee et al. / US / J Trauma 24+24 / 48 / Polyglactin Abdominal coverage Delayed primary fascial
mesh after damage control closure
laparotomy or abdominal
compartment syndrome
(COA)
2008 Blume et al. / USA / 169+166 – Multicenter Foot ulcers in diabetic Complete ulcer closure
Diabetes Care / 342 / Advanced moist patients (DFU)
wound therapy (AMWT,
predominately hydrogels
and alginates)
2008 Mody et al. / US / Ostomy 24+24 - blinded, prospective DFUs (15), PU (11), NF Wound closure.
Wound Manage / 48 / Wet-to-dry gauze (11), and ‘other’ (11)
dressings (ALL)
2009 Stannard et al./ US / J 35+23 / 58 / Standard fine Open fractures with soft Deep wound infection
Orthop Trauma mesh gauze dressing tissue defects – Extremity or osteomyelitis, wound
trauma wounds (ETW) dehiscence
2010 Chio et al. / USA / 23+27 / 50 / Static pressure Integration of split- Area of graft failure
Otolaryngol Head Neck dressing thickness skin grafts
Surg (STSG)
2010 Perez et al. / Haiti / Am J 20+20 / 40 / Conventional Complex wounds in a Complete wound healing
Surg saline-soaked gauze dressing resource-poor hospital
vs homemade wound (ALL)
vacuum-dressing system
2010 Saaiq et al. / Pakistan / J Coll 50+50 - single blinded / 100 Pretreatment STSG, Graft take, wound healing
Physicians Surg Pak / Normal saline gauzes wound bed preparation time
(WBP)
nD 0 / no There were no differences between delayed primary fascial closure rates in the VAC
(31%) or MESH (26%) groups. ‘CONCLUSIONS: MESH and NPWT are both useful methods
for abdominal coverage, and are equally likely to produce delayed primary closure. The fistula
rate for NPWT is most likely due to continued bowel manipulation with NPWT changes with a
feeding tube in place-enteral feeds should be administered via nasojejunal tube. Neither method
precludes secondary abdominal wall reconstruction.’
112 0.007 / no A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of
169, 43.2%) than with AMWT (48 of 166, 28.9%) within the 112-day active treatment
phase (p=0.007).The Kaplan-Meier median estimate for 100% ulcer closure was 96
days (95% CI: 75.0–114.0) for NPWT and not determinable for AMWT (p=0.001).
‘CONCLUSIONS: NPWT appears to be as safe as and more efficacious than AMWT for the
treatment of diabetic foot ulcers.’
70 0 / PU <0,05 / no No statistically significant differences in time to closure between the two treatment groups
were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for
treatment and 27 +/- 10.6 days in control group, p=0.05). ‘CONCLUSIONS: These results
suggest that inexpensive materials can be utilized for NPWT wound closure in a developing
country.’
nd 0,024 / yes Control patients developed 2 acute infections (8%) and 5 delayed infections (20%), for a
total of 7 deep infections (28%), whereas NPWT patients developed 0 acute infections,
2 delayed infections (5.4%), for a total of 2 deep infections (5.4%).There is a significant
difference between the groups for total infections (p=0.024).The relative risk ratio is 0.199
(95% confidence interval: 0.045-0.874), suggesting that patients treated with NPWT were
only one-fifth as likely to have an infection compared with patients randomised to the
control group. NPWT represents a promising new therapy for severe open fractures after
high-energy trauma patients developed 2 acute infections (8%) and 5 delayed infections
(20%), for a total of 7 deep infections (28%), whereas NPWT patients developed 0 acute
infections, 2 delayed infections (5.4%), for a total of 2 deep infections (5.4%).There is a
significant difference between the groups for total infections (p=0.024). ‘CONCLUSION:
The relative risk ratio is 0.199 (95% confidence interval: 0.045-0.874), suggesting that patients
treated with NPWT were only one-fifth as likely to have an infection compared with patients
randomized to the control group.’
nD 0,361 / no Percentage of area of graft failure between the groups also showed no difference (4.5%
SPD versus 7.2% NPWT, P = 0.361). ‘CONCLUSIONS: Although an attractive option for
wound care, the NPWT does not appear to offer a significant improvement over an SPD in
healing of the RFFF donor site.’
25 0,013 / no The time required to achieve complete healing was 16 days in the home made NPWT
group compared with 25 days in the WET group (p=0.013). ‘CONCLUSIONS: The
homemade NPWT should be considered in underdeveloped countries to provide modern
management for complex wounds because healing is significantly faster compared with
conventional wound care. Although the HM-VAC is more costly than the conventional approach,
it is probably affordable for most resource-poor hospitals.’
nD Positive tendency / no Marked differences were found in favour of the NPWT therapy group with respect
to the various wound management outcome measures studied. i.e. graft take (greater
than 95% graft take in 90% of NPWT therapy group versus 18% of controls), wound
healing time (2 weeks postgrafting in 90% of NPWT therapy group vs. 18% of controls).
‘CONCLUSION: NPWT therapy should be employed in the pre-treatment of wounds planned
to be reconstructed with STSG, since it has marked advantages in the wound bed preparation
compared with the traditional normal saline gauze dressings.’
2011 Karatepe et al. / Turkey / 30+37 / 67 / Standard Diabetic foot wound Healing time (time from
Acta Chir Belg wound care (DFU) hospital admission to the
time of re-epithelisation)
2011 Petkar et al. / India / Burns 21+19 / 40 / Conventional Skin graft in burns (STSG) Amount of graft take,
dressing consisting of duration of dressings for the
Vaseline gauze & cotton pad grafted area
2012 Bloemen et al. / 21+21+22+22 – Skin graft in burns (STSG) Graft take rate, graft quality
Netherlands / Wound Multicenter / 86 / With or
Repair Regen without a dermal substitute
and with or without NPWT
2012 Liao et al. / China / 30+30 / 60 / Conventional Skin graft (STSG) Skin graft survival rate, graft
Zhongguo Xiu Fu Chong dressing quality
Jian Wai Ke Za Zhi
2012 Serclova et al. / Czech 28+29 / 57 / Primary Abdominal coverage Delayed primary fascial
Republic / Rozhl Chir abdominal wall closure after damage control closure, mortality
laparotomy or abdominal
compartment syndrome
(COA)
2013 Banasiewicz et al. / Poland / 10+9 / 19 / Standard Pilonidal sinuses (PSD) Wound size, time of surgery,
Pol Przegl Chir wound dressing time of wound healing.
2014 Biter et al. / Netherlands / 24+25 / 49 / Standard open Pilonidal sinus disease Time to complete wound
Dis Colon Rectum wound care (PSD) healing.
nD < 0.05 / no Healing time in the NPWT group was significantly reduced (p<0.05). All 8 domains of SF-
36 and MCS and PCS scores improved remarkably after NPWT therapy. ‘CONCLUSION:
NPWT therapy was found to be effective in the treatment of chronic diabetic ulcers. The
improvement of quality of life demonstrates a clear-cut indication in this particular group of
patients.’
11 < 0.001 / no Final graft take at nine days in the study group ranged from 90–100% with an average of
96.7% (standard deviation: 3.55).The control group showed a graft take ranging between
70 and 100 percent with an average graft take of 87.5% (standard deviation: 8.73). Each
of these differences was found to be statistically significant (p<0.001). ‘CONCLUSION:
Negative pressure dressing improves graft take in burns patients and can particularly be
considered when wound bed and grafting conditions seem less-than-ideal. The negative pressure
can also be effectively assembled using locally available materials thus significantly reducing the
cost of treatment.’
12 months 0 / significant better Graft take and epithelialisation did not reveal significant differences. Highest elasticity was
/ no measured in scars treated with the substitute and TNP, which was significantly better
compared to scars treated with the substitute alone. ‘CONCLUSION: This randomized
controlled trial shows the effectiveness of dermal substitution combined with NPWT in burns,
based on extensive wound and scar measurements.’
1-3 years < 0.05 / < 0.05 / no The skin graft survival rate, wound infection rate, reamputation rate, times of dressing
change, and the hospitalization days in test group were significantly better than those in
control group [90.0% versus 63.3%, 3.3% versus 20.0%, 0 versus 13.3%, (2.0±0.5) times
vs. (8.0±1.5) times, and (12.0±2.6) days vs. (18.0±3.2) days, respectively] (p<0.05). At
last follow-up, the scar area and grading, and two-point discrimination of wound in test
group were better than those in control group, showing significant differences (p<0.05).
‘CONCLUSION: Compared with direct anti-taken skin graft on amputation wound, the wound
could be closed primarily by using the NPWT combined with anti-taken skin graft. At the same
time it could achieve better wound drainage, reduce infection rate, promote good adhesion of
wound, improve skin survival rate, and are beneficial to lower the amputation level, so it is an
ideal way to deal with amputation wound in the phase I.’
nD DPFC<0.01 / M The mortality rate was significantly lower in the NPWT laparostomy group in comparison
<0.01 / no with the primary closure group (3 patients, 11% versus 12 patients, 41%; p=0.01). A
complete closure of the abdominal wall including fascia and complete abdominal wall
healing was achieved in 80% of survivors in the NPWT group, compared to 29% in
the primary closure group (p = 0.01). ‘CONCLUSIONS: Primary NPWT laparostomy is an
effective and safe method in the treatment of severe peritonitis. Keeping good clinical practice,
especially using dynamic suture as early as after the index surgery and the timely closure of
laparostomy as soon as the indication disappears (according to relevant criteria) leads to a
significantly higher abdominal wall healing rate, icluding fascial closure, than after peritonitis
treatment without laparostomy.’
nD Positive tendency / no In NPWT treated group the wound size and time of surgery were similar to control
group.Time of wound healing, recovery and the pain after surgery in days 4-7 were
reduced in comparison to the standard treated group. ‘CONCLUSIONS: NPWT therapy
can be easily used in an outpatient setting, mobile device is highly accepted, operation of
the equipment is simple. NPWT therapy significantly decreases the time of wound healing
and absenteeism from work as well as the postoperative late pain.’
94 0.44 / no Complete wound healing was achieved at a median of 84 days in the NPWT group
versus 93 days in control patients (p=0.44). ‘CONCLUSION: It is feasible to apply vacuum
therapy in the treatment of pilonidal sinus disease, and it has a positive effect on wound size
reduction in the first 2 weeks. However, there is no difference in time to complete wound
healing and time to resume daily life activities.’
2014 Kakagia et al. / Greece / 42+40 / 82 / Shoelace Leg fasciotomy wound Time to definite closure
Injury technique (ETW)
2014 Lone et al. / India / Diabet 28+28 / 56 / Conventional DFU Time to prepare the
Foot Ankle dressing wound for closure either
spontaneously or by surgery
2014 Monsen et al. / Sweden / J 10+10 / 20 / Alginate Deep perivascular groin Time to full skin
Vasc Surg therapy wound infection after epithelialisation
vascular surgery (Szilagyi
grade III) (PGI)
2015 Kirkpatrick et al. / Canada / 23+22 / 45 / Barker’s Abdominal sepsis (COA) Delayed primary fascial
Ann Surg vacuum pack closure (DPFC), Mortality
2015 Rencuzogullari et al. / Turkey 20+20 / 40 / Bogota bag Open abdomen, Delayed primary fascial
/ Ulus Travma Acil Cerrahi technique abdominal sepsis (COA) closure (DPFC), Mortality
Derg
7 ! minus 0,001 / no Wound closure time was significantly higher in NPWT group compared to control group
(p=0.001; 95% CI of the difference:1.8–6.3 days). ‘CONCLUSIONS: Both NPWT and the
shoelace technique are safe, reliable and effective methods for closure of leg fasciotomy wounds.
NPWT requires longer time to definite wound closure and is far more expensive than the
shoelace technique, especially when additional skin grafting is required.’
42 + / no Granulation tissue appeared in 26 (92.85%) patients by the end of week 2 in NPWT
group, while it appeared in 15 (53.57%) patients by that time in control group. 100%
granulation was achieved in 21 (77.78%) patients by the end of week 5 in NPWT group
as compared with only 10 (40%) patients by that time in control group. ‘CONCLUSION:
NPWT appears to be more effective, safe, and patient satisfactory compared to conventional
dressings for the treatment of DFUs.’
104 0.026 / no Time to full skin epithelialisation was significantly shorter in the NPWT group (median,
57 days) compared with the alginate group (median, 104 days; p=0.026). ‘CONCLUSIONS:
NPWT achieves faster healing than alginate therapy after wound debridement for deep
perivascular wound infections in the groin after vascular surgery. This finding does not allow
further inclusion of patients from an ethical point of view, and this study was, therefore, stopped
prematurely’
90 DPFC-0.17 / M-0.04 The cumulative incidence of primary fascial closure at 90 days was similar between groups
/ no (hazard ratio, 1.6; 95% CI: 0.82–3.0, p=0.17). However, 90-day mortality was improved
in the NPWT group (hazard ratio, 0.32; 95% confidence interval, 0.11–0.93; p=0.04).
‘CONCLUSIONS: This trial observed a survival difference between patients randomized to the
NPWT versus Barker’s vacuum pack that did not seem to be mediated by an improvement in
peritoneal fluid drainage, fascial closure rates, or markers of systemic inflammation.’
nD DPFC-+ / M-+ / no Primary closure of fascia was considered appropriate in 16.9 days in the NPWT group
and 20.5 days in the Bogota bag group. 12 patients (30%) died during the study. Among
the deceased patients, 5 (12%) were in the NPWT group, whereas, 7 (17.5%) belonged
to the Bogota bag group. ‘CONCLUSION: Based on these results, it is suggested that VAC
has advantages when compared to the Bogota bag as a temporary closure method in the
management of abdominal compartment syndrome.’
Appendix 4. TOP 20 journals publishing peer-reviewed articles dealing with NPWT
(Literature search as of 31 Decemeber 2015) Impact factor according to (2013)
Rank Journal Number Impact Factor
1 Int Wound J 181 2.150
2 Zentralbl Chir 116 1.048
3 J Wound Care 113 1.069
4 Plast Reconstr Surg 102 2.993
5 Ostomy Wound Manage 87 1.122
6 Ann Plast Surg 74 1.494
7 J Plast Reconstr Aesthet Surg 74 1.421
8 Wound Repair Regen 57 2.745
9 Interact Cardiovasc Thorac Surg 55 1.155
10 Ann Thorac Surg 53 3.849
11 Wounds 38 0.538
12 J Wound Ostomy Continence Nurs 36 1.177
13 J Trauma 33 2.961
14 Int J Low Extrem Wounds 33 0.928
15 J Orthop Trauma 31 1.803
16 Adv Skin Wound Care 30 1.106
17 Eplasty 26 0.000
18 Eur J Cardiothorac Surg 24 3.304
19 Am Surg 23 0.818
20 Am J Surg 22 2.291
Appendix 5. Number of publications for the various evidence levels dealing with
‘NPWT’ (titles and any field) according to the Oxford Centre for Evidence-Based
Medicine (Oxford CEBM). Literature search as of 31 December 2015
Evidence Therapy / Prevention, Risks / Side-Effects Number (%)
Level
1a Systematic review (with homogeneity) of RCTs 6 (0.2%)
1b Individual RCT (with narrow confidence interval, group size > 20 pts) 38 (1.2%)
1c All or none* 0
2a Systematic review (with homogeneity) of cohort studies 7 (0.2%)
2b Individual cohort study (incl. low quality RCT, e.g. follow-up < 80%) 78 (2.4%)
2c ‘Outcomes’ research, ecological study 0
3a Systematic review (with homogeneity) of case-control studies 55 (1.7%)
3b Individual case-control studies 13 (0.4%)
4 Case series (and poor-quality cohort studies and poor case-control studies), retrospective 73 (2.2%)
studies, historical comparison
4/5 Expert opinion without explicit critical appraisal, or based on physiology, bench research or 2778 (84.5%)
‘first principles’
.- . Technical reports, research articles 239 (7.3)
Adapted to the Classification by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin
Dawes (March 2009)1; *e.g. when all patients died before the therapy became available, but some now survive on it, or when
some patients died, but none now die on it.
Appendix 6. Flow chart (papers identified n=3287, RCTs with clearly defined endpoints
n=27)
NPWT literature (n=3287)

(as of 31 Dec 2015)
Minus: (n=3016)
• Systematic reviews
• Case reports/ case series
• Technical reports, research articles, editorials, expert opinions
Comparing studies (n=271)
Minus: (n=195)
• Individual cohort studies
• Case-control studies
• Poor-quality cohort studies
• Retrospective comparisons, historical comparisons
Randomised controlled trials (RCT) studies (n=76)
Minus: (n=48)
• Trials comparing NPWT modifications (n=11)
• Trials comparing viNPT and convention therapy (n=8)
• Double ‘use’ of identical patient groups (n=6)
• Focus on non relevant endpoints (n=23)
Randomised controlled trials (RCT) studies

with relevant primary endpoints (n=27)
Split thickness skin graft, STSG (n=6)

Endpoint: Graft take rate, graft quality
Pilonidal sinus disease, PSD (n=2)
Endpoint: Time to definitive wound closure
Diabetic foot ulver, DFU (n=5)
Endpoint: Time to definitive wound closure, time to
prepare for wound closure
Lower Leg Ulcer, LLU (n=1)
Endpoint: Time to complete wound healing
Closure open abdomen, COA (n=4)
Endpoint: Delayed primary fascial closure, mortality
Wound bed preparation, WBP (n=1)
Endpoint: Graft take rate
All wounds, ALL (n=4)
Endpoint: Time to definitive wound closure, time to
prepare for wound closure
Postoperative groin infection, PGI (n=1)
Endpoint: Time to complete wound healing
Traumatic extremity wounds, TEW (n=2)
Endpoint: SSI, time to closure
Skin substitute fixation, SSF (n=1)
Endpoint: Integra take rate
Appendix 7. Number of articles published on (closed incisional negative pressure
treatment (ciNPT) und negative pressure wound therapy and instillation (NPWTi) in
peer-reviewed journals in the last two decades (blue columns – number per year for
ciNPT literature (bright blue portion of comparing trials in absolute numbers, blue line =
trendline), the red columns – number per year for NPWTi literature (bright red portion
of comparing trials in absolute numbers, red line = trendline). Based on literature
research as of 31 December 2015
40
35
30
25
20
15
10
0
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
ciNPT-All ciNPT-Studies NPWTi-All NPWTi-Studies
Appendix 8. Development of the spectrum of indications up to 2015. The assigned time
is based on the date of publication
Open fracture
1993–1994 Fasciotomy
Deep soft tissue defect
Acute osteitis
1995–1996 Chronic osteitis
Pressure sore
1997–1998 Mesh-graft fixation
Enterocutaneous fistula Dorsal spondylodesis infection Amputation wound

Degloving injuries Deep sternal wound infection Fournier cangrene
1999–2000 Lymphocutaneous fistula Wound defects face & skull Exposed tendon
Flap donor site defect Hidradenitis suppurativa Diab foot syndrome
Venomous bite injury V. Saphena donor-site complication TKA wound dehiscence
Abdominoplasty WHC Defects after musculoskeletal sarcoma resection Open abdomen

Open trauma abdomen Covering exposed orthopaedics hardware Integra fixation
2001–2002 Covering exposed bone Vascular bypass site infection Giant omphalocele
Early infection THA Rectal anastromotic leakage
Nonvenomous bite injury Salvage of mash after ventral hernia repair
Cervicofascial or Neck NF Renal transplantation WD Sinus pilonidalis

Intrapleural bronchus SI Prelaminating of flaps Abdominal WD
2003–2004 Open abdomen in Neonates & toddler Vaginal construction Ablatio oculi
Intensified local radiation treatment Necrotizing faszitis Ulcus cruris
Gynecologic oncology WD Paget’s disease Burn injury
Intraoral application (mandibular ceratocyst) Perineal oncology WD Chest wall defect
Abdominal compartment sydrome Open abomen in pregnancy Pleural empyema
Wound defects neck wounds Penoscrotal elephantiasis Peristomal WD
2005–2006 Soft tissue defect in neonates Pyoderma gangrenosum Gastroschisis
Incisional wound - prevention Vesicocutaneous fistula Penile wound
Pallation (malignant wound) Tuberculous abscess War wounds
Descending necrotizing mediastinitis Pediatric post-sternotomy mediastinitis
Pacemaker pocket infection Oro-/pharyngocutaneous fistula
2007–2008 Necrotising pancreatitis Intrathoracic GE anastomotic leakage
Salvage of free flap Tissue engineering
Frostbite
Auricular recontruction
Primary lymphedema
2009–2010 Bronchopleual fistula
Urinary fistula
Maxillofacial reconstruction
Laryngectomy wound dehiscence Anterior tracheal necrosis Candidal mediastinitis

Ulcerative necrobiosis lipoidica Abdominal dermolipectomy Scrotal lymphangiomatosis
2011–2012 Abdominal compartment sydrome Esophageal leakage Scleroderma
Neonates with complex gastroschisis Vulvectomy Martorell ulcer
Dermatofibrosarcoma protuberans Dura mater defects

Chylous fistula management Intractable auricular defects
2013–2014 Orocutaneous fistula Penile reconstruction vesicocutaneous
Vaginoplasty fistula
Episiotomy dehiscence Esophagotracheal fistula

2015–2016 Preseptal orbital cellulitis Pediatric frostbite
Reconstruction of scrotal sac Cervical esophageal perforation
2017–2018
2019–2020
Appendix 9. Comparitive studies ‘standard wound therapy’ versus NPWTi and NPWT
versus NPWTi
Year Author / Country / Study/Evidence- Group size Modus of instillation
Journal level
2008 Gabriel et al. / US / Int Retrospective control 15 NPWTi + 15 Polyhexanide
Wound J group - low quality / 4 (standard moist wound-
care therapy)
2009 Timmers et al. / Retrospective case- 30+94 (implantation Irrigation through the tubes
Netherlands / Wound control cohort study / 4 of gentamicin three times a day with a
Repair Regen polymethylmethacrylate polyhexanide antiseptic
beads and long-term solution
intravenous antibiotics)
2012 Goss et al. / US / J Am Prospective pilot study n=8: Sharp surgical NPWTi with quarter strength
Coll Clin Wound Spec - Cohort study - low debridement followed bleach solution
quality / 4 by NPWTi
versus
n=8: Standard algorithm
(sharp surgical
debridement followed
by NPWT)
2014 Gabriel et al. / US / Retrospective analysis 34 (NPWT) +48 Fluid: saline or polyhexanide
Eplasty cohort study / 3b; (NPWTi)
hypothetical economic
model using cost
assumptions
2014 Kim et al. / US / Plast Retrospective, historical, NPWT: n = 74; NPWTi: With and without instillation
Reconstr Surg cohort-control study - n = 34, dwell time 6 min,
low quality / 4 n=33, dwell time n=20
minutes
Wounds Endpoints Results/conclusions
Complex, infected Days of treatment, NPWT-instillation group required fewer days of treatment (36.5±13.1 versus
wounds Reduction of infection, 9.9±4.3 days, p<0.001), cleared of clinical infection earlier (25.9 +/- 6.6 versus
wound closure, 6.0±1.5 days, p<0.001), had wounds close earlier (29.6±6.5 versus 13.2±6.8
inhospital stay days, p<0.001) and had fewer in-hospital stay days (39.2±12.1 versus 14.7±9.2
days, p<0.001).
CONCLUSION: ‘The use of NPWT instillation may reduce cost and decrease
inpatient care requirements for these complex, infected wounds.’
Posttraumatic Time to wound NPWTi: Rate of recurrence of infection was 3/30 (10%), 55/93 (58.5%) of the
osteomyelitis closure, number of controls had a recurrence (p<0.0001). NPWTi: Total duration of hospital stay
after surgical surgical procedures, was shorter and number of surgical procedures smaller as compared with the
debridement recurrence of controls (all p<0.0001). CONCLUSION: ‘... in posttraumatic osteomyelitis negative
infection pressure instillation therapy reduces the need for repeated surgical interventions in
comparison with the present standard approach.’
Contaminated Efficacy of wound bed The mean CFU/gram tissue culture was statistically greater - 3.7x106 (±4 x
chronic lower leg preparation, CFU/ 106) in the NPWTi group, while in the standard group (NPWT) the mean was
and foot wounds gram tissue culture 1.8x 106 (±2.36 x 106) CFU/gram tissue culture (p=0.016). The mean absolute
reduction in bacteria for the NPWTi group was 10.6x106 bacteria per gram
of tissue while there was a mean absolute increase in bacteria for the NPWT
group of 28.7x106 bacteria per gram of tissue, therefore there was a statistically
significant reduction in the absolute bioburden in those wounds treated with
NPWTi (p=0.016). CONCLUSION: ‘Wounds treated with NPWTi (in this case with
quarter strength bleach instillation solution) had a statistically significant reduction in
bioburden, while wounds treated with NPWT had an increase in bioburden over the
7 days.’
Extremity and Clinical outcomes, RESULTS showed significant differences (p<0.0001) between NPWTi-d
trunk wounds cost-differences and NPWT patients, respectively, for the following: mean operating room
debridements (2.0 versus 4.4), mean hospital stay (8.1 versus 27.4 days), mean
length of therapy (4.1 versus 20.9 days), and mean time to wound closure (4.1
versus 20.9 days). Hypothetical economic model showed potential average
reduction of $8143 for operating room debridements between NPWTi-d
($6786) and NPWT ($14,929) patients. CONCLUSION: ‘... NPWTi-d appeared to
assist in wound cleansing and exudate removal, which may have allowed for earlier
wound closure compared to NPWT. Hypothetical economic model findings illustrate
potential cost-effectiveness of NPWTi-d compared to NPWT.’
Acutely and Time to final surgical Number of operative visits was significantly lower for the 6- and 20-minute
chronically infected procedure, hospital dwell time groups (2.4±0.9 and 2.6±0.9, respectively) compared with the
wounds stay, number of no-instillation group (3.0±0.9) (p≤0.05). Hospital stay was significantly shorter
operative visits for the 20-minute dwell time group (11.4±5.1 days) compared with the no-
instillation group (14.92±9.23 days) (p≤0.05). Time to final surgical procedure
was significantly shorter for the 6- and 20-minute dwell time groups (7.8±5.2
and 7.5±3.1 days, respectively) compared with the no-instillation group
(9.23±5.2 days) (p≤0.05). Percentage of wounds closed before discharge and
culture improvement for Gram-positive bacteria was significantly higher for the
6-minute dwell time group (94 and 90%, respectively) compared with the no-
instillation group (62 and 63%, respectively) (p≤0.05). CONCLUSION: ‘NPWTi (6-
or 20-minute dwell time) is more beneficial than standard NPWT for the adjunctive
treatment of acutely and chronically infected wounds ...’
2014 Tao et al. / China / Retrospective cohort NPWT mesh-mediated nD
Gastroenterol Res Pract study - low quality / 4 fascial traction and
(n=73). NPWTi: n=61
2015 Kim et al. / US / Plast Prospektive randomized n= 123 Comparing 0.9% normal saline
Reconstr Surg controlled trial / 2b versus 0.1% polyhexanide plus
0.1% betaine
2015 Sun et al. / China / Prospektive randomized NPWT (A, n = 11) Comparing 0.9% normal saline
Zhongguo Xiu Fu Chong controlled trial / 2b NPWTi + saline (B, n = versus insulin solution
Jian Wai Ke Za Zhi 11) , NPWTi + unsulin
solution (C, n = 12)
2015 Wen et al. / China / Prospektive randomized NPWT (A, n=11) Comparing 0.9% normal saline
Zhonghua Shao Shang controlled trial / 2b NPWTi + saline (B, n = versus oxygen loaded fluid
Za Zhi 11) , NPWTi + oxygen
loaded fluid irrigation (C,
n = 12)
Open Septic Rate of delayed The DPFC rate in the instillation group was significantly increased (63% versus
Abdomen primary fascial closure 41%, p=0.011). The mortality with OA was similar (24.6% versus 23%, p=0.817)
(DPFC) between the two groups. However, time to DPFC (p= 0.003) and length of
stay in hospital (p=0.022) of the survivals were significantly decreased in the
instillation group. In addition, NPWT-instillation (OR: 1.453, 95%CI: 1.222-4.927,
p=0.011) was an independent influencing factor related to successful DPFC.
CONCLUSION: ‘VAWCM-instillation could improve the DPFC rate but could not
decrease the mortality in the patients with open septic abdomen.’
Infected wounds Number of There was no statistically significant difference in the surrogate outcomes with
that required operative visits, the exception of the time to final surgical procedure favoring normal saline (p=
hospital admission length of hospital 0.038). CONCLUSION: ‘0.9% normal saline may be as effective as an antiseptic
and operative stay, time to final (0.1% polyhexanide plus 0.1% betaine) for negative-pressure wound therapy with
debridement. surgical procedure, instillation for the adjunctive inpatient management of infected wounds.’
proportion of closed
or covered wounds,
and proportion of
wounds that remained
closed or covered at
the 30-day follow-up
Chronic diabetic Concentration of HE staining: few new microvessels and fibroblasts in group A after treatment;
lower limb ulcer insulin growth factor more new microvessels and fibroblasts were observed in group B; and many
1 (IGF-1), tumor new microvessels and fibroblasts were found in group C. Coverage rate /
growth factor a (TNF- thickness of granulation tissue and clearance rate of bacteria in group C were
alpha), nitric oxide significantly higher (p<0.05). IGF-1 and NO significantly increased and TNF-
(NO) in necrotic alpha significantly decreased in group C when compared with those in group A
tissue. Coverage (p<0.05). Compared with group B, IGF-1 and NO contents were significantly
rate, thickness of increased at 3-6 days and at 2-6 days respectively, and TNF-alpha content was
granulation tissue, significantly decreased at 3-6 days in group C (p<0.05). Time second stage
clearance rate of operation in group C was significantly shorter than that in groups A and B
bacteria, histology of (p<0.05. Survival rate of grafted skin or flap in group C was significantly higher
granulation tissue (HE than that in groups A and B (p<0.05). CONCLUSION: ‘Treatment of diabetic
staining) after 6 days lower limb ulcers with … irrigation of insulin solution combined with NPWTi can
of treatment reduce inflammatory reaction effectively, promote development of granulation tissue,
improve recovery function of tissue, increase the rate and speed of wound healing
obviously, but it has no effect on blood glucose levels.’
Chronic venous leg Granulation tissue Granulation tissue coverage rate of wounds in patients of group C was higher
ulcer coverage rate, than that of group A or B (p<0.05 or p<0.01). HE staining: more abundant new
amount new born born microvessels and fibroblasts in group C; Masson staining: more abundant
microvessels and fresh collagen distributed orderly. pO2 skin around the wounds in patients of
fibroblasts, fresh group C significant higher (p < 0.01). Expression of VECF in the wounds of
collagen, pO2 skin, patients in group C was higher than that in group A or B (p<0.05 or p<0.01).
Expression of VECF, On PTD 7, the number of type I macrophages in granulation tissue of patients
number of type I + was respectively 14.3 +/- 2.3, 11.5±3.0, and 10.7±2.3 per 400 times vision field
II macrophages in in groups A , B, and C (F=25.14, p<0.01), while the number in group C was
granulation tissue less than that in group A or B (p<0.05 or p<0.01). On PTD 7, the number of
type II macrophages in granulation tissue of patients was respectively 32.7±3.2,
35.1±3.3 , and 41.3±3.2 per 400 times vision field in groups A, B, and C
(F=81.10, p<0.01), and the number in group C was lager than that in group A
or B (p<0. 01). CONCLUSIONS: ‘NPWT combined with irrigation of oxygen
loaded fluid can raise the pO2-skin around the wounds effectively, promoting
the transition of macrophages from type I to type II, thus it may promote the
growth of granulation tissue, resulting in a better recipient for skin grafting or
epithelisation.’
Appendix 10. Overview of all published randomised controlled trials and meta-analyses
dealing with ciNPT in all surgical fields
Year Author / journal EBM-Level* Number of patients/study design
2015 Scalise et al. / Italy / 1a (systematic review, 1 biomedical engineering study, 2 animal studies, 15 human
Int Wound J meta-analysis of RCT’s, studies for a total of 6 randomized controlled trials, 5 prospective
other comparative cohort studies, 7 retrospective analyses, were included
studies)
2015 Semsarzadeh et al. / 1a (systematic review, n=8 studies implemented (based on a search for experimental
USA / Plast Reconstr meta-analysis of RCT’s, and epidemiological study designs, including randomized
Surg other comparative controlled trials, pseudo-randomized trials, quasi-experimental
studies) studies, before and after studies, prospective and retrospective
cohort studies, case control studies, and analytical cross sectional
studies
2015 Sandy-Hodgetts et 1a (systematic review, n=8 studies implemented (based on a search for experimental
al. / Australia / JBI meta-analysis of RCT’s, and epidemiological study designs, including randomized
Database System Rev other comparative controlled trials, pseudo-randomized trials, quasi-experimental
Implement Rep studies) studies, before and after studies, prospective and retrospective
cohort studies, case control studies, and analytical cross sectional
studies
2015 Gillespie et al. / 1b (nonmasked, Group A: ciNPT, n=35

Australia / Surg Innov randomized controlled Group B: Control, n=35, standard care hydrocolloid & 2
pilot trial) absorbent dressings; Follow up: 6 weeks
2014 Webster et al. / 1a (meta-analysis Meta-analysis

Australia / Cochrane of RCT’s, other
Database Syst Rev comparative studies)
2013 Ingargiola et al. / USA 1a (databases from Meta-analysis

/ Eplasty 2006 to 2012 for
published articles (meta-
analysis of RCT’s, other
comparative studies)
Type of wounds Primary outcome/results Conclusion/comment
All type of wounds Decrease in the incidence of infection, sero- Because of limited studies, it is difficult to
haematoma formation and of the re-operation rates make any assertions on the other variables,
when using ciNPT. Lower level of evidence was found suggesting a requirement for further studies
on dehiscence: decreased in some studies. for proper recommendations on iNPWT.
All type of wounds The overall weighted average rates of SSI in the ciNPT is a potentially effective method for
ciNPT and control groups were 6.61% and 9.36%, reducing SSI. It also appears that ciNPT may
respectively. This reflects a relative reduction in be associated with a decreased incidence of
SSI rate of 29.4 %. A decreased likelihood of SSI dehiscence, but the published data available
was evident in the ciNPT group compared with were too heterogeneous to perform meta-
the control group across all studies, and across all analysis.
four incision location subgroups. Overall rates of
dehiscence in ciNPT and control groups were 5.32%
and 10.68 %, respectively.
Trauma, Endpoints: Occurrence of SSI or dehiscence as Demonstrated association between the use
cardiothoracic, measured by the following: SSI - superficial and deep; of ciNPT and reduction in SSI.
orthopedic, surgical wound dehiscence; wound pain; wound
abdominal, or vascular seroma; wound hematoma.
surgery Statistically significant difference in favor of the use of
ciNPT as compared to standard surgical dressings was
found for SSI.
Elective hip Endpoints: Postoperative complications (SSI, length ‘A reduction of 3% in SSI incidence suggests
arthroplasty of stay, readmission) and skin complications (bruising, that a definitive trial requires approximately
seroma, hematoma, dehiscence) 900 patients per group. Yet there is
SSI incidence was 2/35 in group A, 3/35 in group uncertainty around the benefit of NPWT
B [RR = 0.67; 95% CI: 0.12–3.7; p=0.65]. ciNPT after elective hip arthroplasty.’
patients experienced more postoperative wound
complications [RR: 1.6; 95% CI: 1.0–2.5; p=0.04].
3 trials involved skin Evidence for the effects of ciNPT for reducing SSI and Urgent need for suitably powered, high-
grafts, 4 included wound dehiscence remains unclear, as does the effect quality trials to evaluate the effects ciNPT.
orthopaedic patients of ciNPT on time to complete healing. Such trials should focus initially on wounds
and 2 included that may be difficult to heal, such as sternal
general surgery wounds or incisions on obese patients.
and trauma surgery
patients
All type of wounds Literature shows a significant decrease in rates of Possible evidence of a decrease in the
infection when using ciNPT. Results inconsistent incidence of infection with application of
to formulate a clear statement. Because of limited ciNPT. Looking at other variables such as
studies, it is difficult to make any assertions on seroma, dehiscence, seroma, hematoma, and skin
hematoma, and skin necrosis. necrosis show no consistent data and
suggest further studies in order for proper
recommendations for ciNPT.
2012 Stannard et al. / USA / 1b (Prospective Group A: ciNPT, n=141
J Orthop Trauma randomized multicenter Group B: Control, n=122, standard postoperative dressings;
clinical trial) Follow up 6 weeks
2012 Masden et al. / USA / 1b (randomized Group A: ciNPT, n=44

Ann Surg controlled trial) Group B: Control, n=37, standard postoperative dressings;
Average follow-up was 113 days
2011 Howell et al. / USA / 1b (randomized Group A: ciNPT, n=24

Current Orthopaedic controlled trial) Group B: Control, n=36, sterile gauze;
Practice Average follow-up was 113 days
2009 Stannard et al. / USA / 1b (randomized Group A: ciNPT, n=35

J Orthop Trauma controlled trial) Group B: Control, n=23, fine mesh gauze dressing;
Average follow-up was 113 days
*Classification produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes
(March 2009);1 Wound healing problems–wound dehiscence, eschar, or drainage over three weeks post surgery; ‡Significant
wound complications = wound complications that require surgical intervention; BMI–body mass index; ciNPT–closed incision
negative pressure therapy; OR–odds ratio; CI–confidence interval; ciNPT:–closed incision negative pressure therapy; SSI–Sugical
site infection
Blunt trauma patients There were a total of 23 infections in Group B and 14 There have been no studies evaluating ciNPT
with one of three in Group A, which represented a significant difference as a prophylactic treatment to prevent SSI
high-risk fracture in favor of ciNPT (p=0.049). The relative risk of and wound dehiscence of high-risk surgical
types (tibial plateau, developing an SSI was 1.9 times higher in control incisions up to 2012. ciNPT should be
pilon, calcaneus) patients than in patients treated with ciNPT (95% CI: considered for high-risk wounds after severe
requiring surgical 1.03–3.55). Decreased incidence of wound dehiscence skeletal trauma.
stabilization and SSI after high-risk fractures when patients have
ciNPT.
Mostly lower 6.8% of the ciNPT group and 13.5% of the dry No difference in the incidence of SSI or
extremity wound dressing group developed SSI - not statistically dehiscence between the ciNPT and dry
closure significant (p=0.46). No difference in time to develop dressing group.
infection. No statistical difference in dehiscence
between ciNPT and dry dressing group (36.4% versus
29.7%; p=0.54) or mean time to dehiscence (p=0.45).
Overall, 35% of the dry dressing group and 40% of
the ciNPT group had a SSI, dehiscence, or both. Of
these, 9 in the ciNPT group (21%) and 8 in the dry
dressing group (22%) required reoperation.
Total Knee No significant difference of days to a dry wound (4.3 ciNPT did not appear to hasten wound
Replacement days ciNPT, 4.1 days sterile gauze). There were 2 SSI, closure and was associated with blisters.
procedures & BMI one in each arm of the study. Study was stopped There does not appear to be a benefit to
> 30 prematurely when 15 of 24 knees (63%) treated with the routine use of ciNPT in the immediate
ciNPT developed skin blisters. postoperative TKA period.
Severe open fractures Control patients developed 2 SSI (8%) and 5 delayed ciNPT represents a promising new therapy
infections (20%), for a total of 7 deep infections for severe open fractures after high-energy
(28%), whereas ciNPT patients developed 0 acute trauma suggesting that patients treated with
infections, 2 delayed infections (5.4%), for a total of 2 ciNPT were only one-fifth as likely to have an
deep infections (5.4%). Significant difference between infection compared with patients randomized
groups for total infections (p=0.024). The relative risk to the control group.
ratio is 0.199 (95% confidence interval: 0.045-0.874).
Appendix 11. Reimbursement situation in selected EU countries (2016 data)
Country Reimbursement Bought/leased

FRANCE No specific reimbursement No specific reimbursement
No specific funding (DRG funding) All acquisition or leasing are part of the DRG
Private health insurance are not funding either. funding.
However, companies are implementing free leasing
with higher consumable prices.
GERMANY Yes Both

Within the hospital setting
ITALY No reimbursement Both

It is considered part of other procedures. This is up Although not reimbursed, where used it gets a fee
to a single hospital budget per day /dressing change reimbursement
SPAIN No Both
No national reimbursement. Both public and private NWPT devices are leased (customer buys just the
settings acquire NPWT products through direct fungibles), except single use devices (everything
purchasing. bought).
In the public sector, if purchases are above 18K €/ Some private hospitals and insurance companies
year per code of product, they normally proceed prefer to pay a forfeit (cost per day), to get the
through Public Tender (at a Hospital Level service on demand.
normally; still rarely at Regional level due to lack of
homogeneity in the use/demand)
UK Yes Both
In hospital - NPWT is paid for by NHS (devices and Hospitals choose the best business model to suit
consumables). The amount or time that NPWT is their needs and budgets.
provided for depends on the individual hospital and
the budget they have available. An NPWT tarriff
does exist for reimbursement but is rarely used.
Home care Training Protocols
No specific reimbursement Yes Yes
NPWT is restricted to hospital and A specific training is required by the But no national protocol, except a part
Home care through Hospitalization at HAS recommendations for NPWT within the recommendations of the
Home (HAD). The company and the hospitals are HAS underlining the place of NPWT in
The reimbursement however is providing training, (company provide the strategy (firs-second line).
not specific to NPWT and may be training to hospital, hospital provide Regional and local protocols may be
considered similar to DRG. training to patient) available, and developed according to
Community care is not considered as the situation
an indication in the recommendations The company provides protocols based
of the HAS on the cicatrisation step
No Yes No
Not in general reimbursed, just on a Provided by company No protocols exists
case by case decision depending on the
SHI company
Yes/no Yes Yes
Some exceptions are considered in Always by company In some areas: Emilia and Tuscany.
Piemonte, Siciliy, Tuscany and Lumbardy Protocols are provided by specific
for home care /outpatient treatments experts/clinicians chosen by regional
healthcare administrations
Yes/No Yes Yes
Not very often, but it occurs in some Almost always provided by companies At hospital level, but not always: it
hospitals, mainly through portable or (mainly in hospital, but also during depends on each one´s requirements.
single use devices. conferences) There is not a clear consensus nor
The limitation for this use is not strictly assumption of the use at a national
due to budget constrictions, but to the level yet , so it is not a must to having
lack of penetration of the use of NWPT a protocol to use NPWT (big part of
in Spain, compared to conventional the use remains on individual decisions,
wound dressings case by case). Protocols are normally
provided by companies in first instance
(based in evidence/consensus), and
afterwards adopted and adapted
by customers in regards to their
characteristics/needs.
Yes/no Yes Yes
Consumables are reimbursed via UK Training is provided by expert clinicians Lead clinicians in each individual facility
Drug Tarriff but Multi patient use devices as well as the company. Not reimbursed. decide and put in place local protocols.
are not.
Single patient use NPWT is reimbursed
on UK Drug Tariff.
Appendix 12. Comparative studies–health economics
Author Year Country Type of study Study population Intervention
Apelqvist, J., 2008 USA (and RCT 162 patients Patients with post-amputation
et al. Sweden) wounds due to diabetic foot
treated with VAC and standard
MWT
Aydin, U., 2015 Turkey Cohort 21 patients Various treatments for lymphocele
et al. or lymphorrhea
Baharestani, 2008 USA Cohort 562 patients Early vs. late initiation of NPWT
M. M., et al. in treating pressure ulcers and
surgical wounds
Braakenburg 2006 The RCT 65 patients VAC and conventional therapy

A., et al. Netherlands
De Leon, J. 2009 USA Cohort 51 patients NPWT/RCOF and topical

M., et al. advanced moist healing strategies
(non-NPWT)
Dorafshar, A. 2012 USA RCT 87 patients Patients with acute wounds

H., et al. treated with sealed gauze dressing
and VAC
Direct costs Indirect costs Intangible costs Results
Hospital admissions and N/A N/A Compared to standard moist wound therapy
length of stay, number of (MWT), NPWT shows to be cost-effective
surgical procedures and measured in direct costs. The average total cost to
dressing changes, number achieve healing was $25,954 for NPWT-patients, and
of outpatient treatment $38,806 for MWT-patients.
visits, antibiotic usage,
overall costs.
Hospital length of stay, Infection, Pain, irritability Comparison between patients who where treated
duration of treatment, recurrence VAC therapy as first choice treatment (Gr. 1), and
medical costs patients who where treated with various treatments
before VAC or other treatments alone (Gr. 2). Gr.
1 demonstrated more rapid wound healing, early
drainage control, shorter hospital stay, and mean
hospital medical costs of €1,038 versus €2,137 for
Gr. 2.
Number of treatment- N/A N/A For each day NPWT was delayed, almost a day was
days, duration of added to the total length of stay.
treatment while in home
care, length of stay
Median healing time, Bacterial load Comfort Comparison of VAC and other dressings. VAC
total cost per day, cost represented higher comfort, less time involvement
of labour time (time and costs of nursing staff, but overall costs were
involvement of nursing similar for both groups. As were time to primary
staff), total costs endpoint (except for patients with diabetes and/or
cardiovascular disease), wound surface reduction and
bacterial clearance.
Hospital length of stay, N/A N/A Postsurgical LTAC patients who were treated by
average wound volume NPWT/ROCF had a more accelerated rate of
reduction per day, total wound closure, compared to patients treated with
cost of care, cost per unit, advanced moist wound-healing therapy. Lower cost
cost per cubic centimetre per cubic centimetre volume reduction suggests that
reduction in volume, NPWT/ROCF produces a more favourable cost-
overall costs effective solution.
Wound surface area and N/A Pain GSUC is noninferior to VAC with respect to changes
volume, mean cost per in wound volume and surface area in an acute care
day, time required for setting. In addition, GSUC dressings were easier
dressing change and faster to apply, far less expensive ($4.22/day vs.
$96.51/day for VAC) and less painful.
Dougherty, 2008 USA Modelling study N/A Variuos treatments for full-
E. J. thickness, nonhealing diabetic foot
ulcers
Driver, V. 2014 USA Retrospective 324 patients NPWT versus advanced moist
R. and P. A. analysis of RCT wound therapy in treating diabetic
Blume study foot
Echebiri, N. 2015 USA Literature review N/A Focus on NPWT vs. standard
C., et al. + modelling study postoperative dressing in cesarean
delivery
Flack, S., et al. 2008 USA Modelling study N/A Treatment of diabetic foot ulcers
with VAC therapy or either
traditional or advanced wound
dressings
Gabriel, A., 2014 USA Modelling study 82 patients Patients with extremity or trunk
et al. wounds treated with standard
NPWT (V.A.C. Therapy) or
NPWTi-d (V.A.C. Veraflo Therapy)
Ghatak, P. D. 2015 USA RCT 30 patients Treatment of chronic wounds

with NPWT with and without use
of a WED interface layer in the
dressing
Hampton, J. 2015 Denmark Case-series 9 patients Treatment of slow-healing leg- or
pressure ulcers with NPWT
Average 5-year direct N/A QALYs The average QALYs per modality were highest for
wound care cost treatment with PRP-gel (2.87), but next highest for
NPWT-treatment (2.81). The lowest number of
QALYs per modality was achieved with standard
care and human fibroblast (both 2.65). The average
5-year direct wound cost was lowest for PRP-
gel-treatment ($15,159), next lowest for NPWT
($20,964) and highest for standardcare and human
fibroblast ($40,073 and $40,569, respectively). Thus,
PRP-gel represents a potentially attractive treatment,
with NPWT as runner up.
Wound area reduction, N/A N/A Patients treated with NPWT experienced bigger
total cost, median cost per wound area reduction (85%) than patients treated
1 cm2 of closure, cost of with AMWT (62%). The median cost per 1cm2 of
materials wound closure was $1,227 with NPWT and $1,695
with AMWT; however, in the group of patients
who achieved complete wound closure, the cost of
NPWT excelled the cost of AMWT ($10,172 vs.
$9,505).
Cost per treatment, cost Cost of surgical N/A Among patients with a surgical site infection after
of outpatient management site infection caesarean delivery rate of 14% or less, standard
readmission postoperative dressing was the preferred cost-
beneficial strategy. However, for patients with
an infection rate greater than 14%, the use of
prophylactic NPWT was preferred.
Cost per amputation N/A N/A The model results demonstrate improved healing
avoided, cost per QALY, rates (61% versus 59%), more QALYs (0.54 versus
healing rate, overall cost 0.53) and an overall lower cost of care ($52,830
of care versus $61,757 per person) for patients treated with
VAC therapy compared to advanced dressings.
Hospital length of stay, Surgical N/A The study showed a reduction in hospital length of
length of treatment, daily debridements stay, surgical debridements and LOT using NPWTi-d
cost of therapy (V.A.C. Veraflo Therapy) compared to standard
NPWT (V.A.C. Therapy). The comparative cost-
effectiveness should be further assessed.
Number of dressing Infection Pain Use of WED in conjunction with NPWT decreases
changes, cost per patients the need for dressing changes from thrice to twice
a week, and lowers the cost per patient from $2952
to $2345.
Healing rate, frequency of N/A N/A When introduced in the treatment of hard-to-heal
dressing changes, weekly wounds, 2 weeks of NPWT treatment helped
cost of treatment achieve a reduced wound 10 weeks earlier than
predicted, and healing rate continued after NPWT
stopped. Frequency of dressing changes fell from 4
times weekly under conventional therapy, to 2 times
a week with NPWT. Weekly cost of NPWT was on
average 1.6 times higher than the baseline, but fell
to 3 times less when NPWT stopped, owing to the
reduction in dressing changes. NPWT is therefore
concluded to be a cost-effective treatment for hard-
to-heal wounds.
Hermans, M. 2015 USA Cohort 42 patients Treatment of large wounds with
H. E., et al. either NPWT or hydrokinetic fibre
dressing
Hiskett, G. 2010 United Case-series 20 patients Treatment of a variety of acute

Kingdom and chronic wounds with TNP
in either hospital or home care
settings
Hop M. J., 2014 The RCT 86 patients Treatment of burn wounds with
et al. Netherlands SSG with or without dermal
substitutes (DS), and with or
without TNP.
Hutton, D. 2011 USA Modelling study N/A Modern dressings, powered

W. and P. negative pressure and SNaP
Sheehan Wound Care System
Inhoff, O., 2010 Germany Cohort 52 patients Allogenic fascia lata, artificial skin
et al. substitute or NPWT for soft tissue
reconstrution
Kakagia, D., 2014 Greece RCT 50 patients with 82 leg Treatment of leg fasciotomies
et al. fasciotomy wounds with either VAC or the shoelace
technique
Kaplan, M., 2009 USA Cohort 1058 patients Early versus late initiation of
et al. NPWT in treating trauma wounds
Reduction of wound size, N/A Pain Healing trends were similar for wounds treated with
total cost of materials, hydrokinetic dressing and NPWT. Cost of materials
material cost per day and were substantially higher for wounds treated with
per wound, number of NPWT ($2,301.55 per wound versus $661.46 per
dressing changes wound for hydrokinetic dressings). Hydrokinetic
dressings are therefore considered an effective
substitute for NPWT.
Cost of direct wound N/A N/A The cost of treating patients with TNP at home was
treatment, cost per day, less than the cost of treating patients at the hospital
length of treatment (£45.9 and £259.1 per day, respectively).
Costs of personnel, Readmission days Patient productivity Total costs were highest for patients treated with
equipment, materials loss, post-operative both DS and TNP due to high personnel, equipment
and housing, diagnostic scar elasticity and material costs (€2912). The second most
costs, ICU costs, overall expensive treatments were the treatment with
treatment cost, total cost, DS (€2218), and the treatment with TNP (€2180).
hospital length of stay, Thus, standard SSG treatment was by far the least
expensive (€1703). 12 months post-operatively, scar
elasticity was highest in scars treated with DS and
TNP.
Average daily, monthly and Amputations, N/A When compared to standard care, the SNaP system
bi-monthly costs, including debridements, saves over $9000 per wound treated and more than
material costs, clinic visit skin grafts, doubles the number of patients healed. The SNaP
costs, hospitalisation costs, osteomeylitis system has similar healing time to powered NPWT
device rental and home devices, but saves $2300 in Medicare payments or
health care payments. $2800 for private payers per wound treated. The
Long-term costs, including SNaP system could thus save substantial treatment
cost per patient with costs in addition to allowing patients greater
unhealed wound at end of freedom and mobility.
16 weeks. Fraction healed
Length of stay, cost of N/A Postoperative healing NPWT was the most expensive treatment due to
hospitalization, material rate, cosmetic results, high daily rental rates and frequent, time-consuming
costs, duration of surgery, scar stability dressing changes (mean total cost: €7,521). Artificial
surgical costs, length of skin substitute treatment was €4,557 in mean total
outpationt care, number cost, and the fascia lata group was least costly with a
of dressing changes mean total cost of €4,475.
Wound closure time, Infection, N/A VAC requires longer time to definite wound closing
mean daily cost additional than the shoelace method (19,1 days versus 15,1
treatment with days). Furthermore, VAC is far more expensive per
STSG day of treatment (€135 versus €14).
Number of hospital N/A N/A Early-group patients had fewer hospital inpatient
inpatient-and treatment days (10.6 versus 20.6 days), fewer treatment days
days, length of ICU stay, (5.1 versus 6.0 days), shorter ICU stays (5.3 versus
ICU admission rate, total 12.4 days), and higher ICU admission rates (51.5
and variable costs per versus 44.5%) than the late group. Compared
patient discharge with late-group patients, early-group patients had
lower total and variable costs per patient discharge
($43,956 versus $32,175 and $22,891 vs $15,805,
respectively).
Karr, J. C., 2013 USA Case-control- 20 patients Various wounds treated with
et al. series NPWT using a silver antimicrobial
negative pressure dressing
Lavery, L. A., 2007 USA Modelling study NPWT group: 1135 Diabetic foot ulcer treated with
et al. patients, control group: NPWT or wet-to-moist therapy
586 patients
Law, A., et al. 2015 USA Cohort 13,556 patients Patients with chronic wounds
treated with either VAC therapy
from KCI or other non-KCI
models of NPWT
Lewis, L. S., 2014 USA Modelling study N/A Prophylactic NPWT compared
et al. to routine incision care following
laparotomy for gynaecologic
malignancy
Mody, G. N., 2008 India RCT 48 patients Comparison of locally constructed

et al. TNP devices to wet-to-dry gauze
dressings in treating various
wounds
Monsen, C., 2015 Sweden RCT 16 patients NPWT vs. alginate wound
et al. dressings in patients with deep
peri-vascular groin infection
Days to wound closure, N/A N/A Patients treated with NPWT including a silver
wound treatment cost per antimicrobial dressing experienced fewer days to
patient, nursing time per wound closure than patients treated with standard
patient NPWT (50.5 and 61.7 days, respectively). They also
needed fewer hours of nursing time per patient (4.3
versus 15.4) and represented a significantly lower
total cost per patient ($826 versus $5,181).
Successfull treatment N/A N/A A greater proportion of the NPWT-group achieved
endpoint within successful treatment endpoint compared with
timeframe, expected costs wet-to-moist therapy at both 12 weeks (39.5%
of therapy* versus 23.9%) and 20 weeks (46.3% versus 32.8%).
Expected treatment costs were alike for the two
groups if one nursing visit per day for wet-to-moist
patients is assumed, but 42% less for NPWT if two
nursing visits per day are made. Thus, NPWT might
decrease resource use by a given health-care system
compared with standard wet-to-moist therapy.
Inpatient, emergency Comorbidity N/A Patients treated with VAC therapy from KCI had
room and home and scores lower mean total costs ($80,768 versus $111,212
total costs, wound-related measured 12 months after initial NPWT claim),
readmission rates* lower wound-related costs ($20,801 versus $28,647
measured 12 months after initial NPWT claim)
and lower hospital readmission rates than patients
treated with other, non-KCI types of NPWT.
Reduction of cost of N/A N/A The overall cost of incision are was $104 lower for
complication (being the NPWT than for RF. At the lowest cost of NPWT
target of the treatment), ($200), the risk of wound complication must be
cost of treatment, reduced by 33% for NPWT to achieve cost savings.
reduction of cost of re-
hospitalization*
Material costs per Complications Pain The material costs of one TNP dressing change
dressing, total material ($2.27) was app. 5.7 times more expensive than the
cost for reaching materials used for one conventional dressing change
satisfactory closure, ($0.40). Total material costs for reaching satisfactory
duration of treatment closure of two representative pressure ulcers were
$11.35 for TNP treatment and $22 for conventional
treatment. A review of the literature suggests that
outcomes obtained using a locally constructed
TNP device are similar to those obtained using
commercially available devices.
Healing time, number N/A QoL (measured by NPWT therapy in patients with deep peri-vascular
of dressing changes, mobility, self-care, groin infection can be regarded as the dominant
frequency of dressing usual activities, strategy compared to alginate wound dressings, due
changes outside hospital, discomfort and to improved clinical outcome (median 57 and 104
personnel time, total anxiety/depression), days healing time, respectively), with equal cost and
hospitalised care cost, pain QoL-measurements.
cost for wound material,
personnel and policlinical
care
Ozturk, E., 2009 Turkey Cohort 10 patients Patients with Fournier’s gangrene
et al. was treated with conventional
therapy or VAC
Petkar, K. S., 2011 India RCT 40 split-skin grafts on 30 Consecutive burn patients
et al. patients undergoing split-skin grafting
received either conventional
dressing or NPD
Rahmanian- 2011 Germany RCT 42 patients Treatment of acute or chronic
Schwarz, A., wounds with either VAC (KCI) or
et al. an alternative polyurethane foam-
based NPWT system (RENASYS
GO)
Rossi, P. G., 2012 Italy Literature review 17 articles reporting cost NPD versus conventional
et al. analyses treatments in treating various
wounds
Sakellariou, V. 2011 Greece Cohort 32 patients Patients treated for bone and soft-
I., et al. tissue sarcomas and secondary
wound-healing complications with
NPWT or conventional treatment
Tuffaha, H. 2015 Australia Modelling study 92 patients in pilot trial NPWT for reducing SSI for obese
W., et al. including RCT women undergoing caesarean
pilot study delivery
Vaidhya, N., 2013 India RCT 60 patients Treatment of diabetic foot

et al. wounds with either NPWT or
conventional treatment
Vuerstaek, J. 2006 The RCT 60 patients Treatment of chronic leg ulcers

D. D., et al. Netherlands with VAC or conventional wound
and Belgium care techniques
Warner, M., 2010 USA Cohort 24 patients VAC versus antibiotic bead pouch
et al. for the treatment of blast injury of
the extremity
Total cost, length of stay, N/A Pain, need for VAC therapy is superior to conventional therapy
healing success rate, analgesics, mobility, in regards to patient QoL when treating Fournier’s
number of dressing eating habits, ability gangrene. Healing success rate and total costs were
changes, hands-on to shower, patient similar.
treatment time convenience, ease-
of-use
Material costs, graft take Treatment adverse Patient convenience NPT improves graft take in burns patients and can
(healing rate), duration of events, re-grafting be assembled using locally available materials. No
dressing conclusion on total costs.
Median healing time, Adverse events, N/A Material costs were in average 11.7% lower for the
duration of treatment, skin reaction polyurethane foam-based NPWT system than for
number of dressings, total VAC (KCI). There were no significant difference in
and daily material costs healing rates.
Various items included N/A N/A Some clinical and economic benefit of NPT in
from study to study severe chronic and acute wound treatment can be
derived from the literature review.
Length of stay, total costs, Complications e.g. N/A Patients treated with NPWT had a significantly
cost per day infections shorter length of stay than patients undergoing
conventional treatment (mean of 16.5 days versus
25.2 days). Mean total cost for NPWT treatment
was $4,867.3, and $11,680.1 for conventional
treatment. Mean cost per day for NPWT treatment
was $295.1 and $463.6 for conventional treatment.
Total costs, effect and N/A N/A The incremental net monetary benefit of NPWT
EVPI for adopting NPWT was AUD 70, indicating that NPWT is cost-effective
compared with standard dressings. The probability of
NPWT being cost-effective was 65%.
Number of dressings, Worsening Requirements of End point of treatment was achieved in 17.2 days
length of treatment, of condition, analgesics for NPWT group compared to 34.9 days for the
success healing rate, cost requirements of control group, and overall success rate was larger
per dressing, average total antibiotics in NPWT group than in control group (90% versus
cost. In less detail: cost of 76.6%). Number of dressings were 7.46 for NPWT
daily treatment, hospital group and 69.8 for control group, and with a cost
stay and morbidity. per dressing of Rs. 500 and Rs. 200 respectively,
average cost of NPWT was lower than conventional
dressings (Rs. 3,750 versus Rs. 7000).
Time to complete Treatment adverse QoL (measured by VAC should be considered as the treatment of
healing, time for wound events, recurrence mobility, self-care, choice for chronic leg ulcers owing to its significant
bed preparation, total usual activities, advantages in the time to complete healing (29
cost including costs for discomfort and days versus 45 days for conventional methods), its
materials and personnel anxiety/depression), shorter wound bed preparation time (7 days versus
pain 17 days for conventional methods), and the 25–30%
lower total costs.
Total costs, including costs Infections, returns N/A VAC therapy costs in average app. $1000 more per
of materials and cost of to operating room, patient than the antibiotic bed pouch in treating
surgical set-up/charge to more surgeries blast injuries in the extremities.
surgery facility
Webster, J., 2014 Australia Systematic 9 studies NPWT delivered by any mode
et al. literature review compared to any standard
dressing or any advanced dressing,
or comparisons between different
NPWT devices
Whitehead 2011 France Modelling study N/A VAC vs. advanced wound care
S. J., et al. for the treatment of diabetic foot
ulcers
Yang, C. K., 2015 US Case-series + 10 ulcers on 7 patients Treatment of massive chronic

et al. review of medical venous leg ulcers with NPWT
cost estimators
Yao, M., et al. 2012 US Cohort 342 patients Patients with multiple significant
comorbidities and chronic lower
extremity ulcers treated with both
early, intermediate and late NPWT,
as well as standard care
Zameer, A., 2015 India RCT 60 patients Comparison of custom made VAC
et al. therapy and conventional wound
dressings in treating non-healing
lower limb ulcers
Time to complete healing, Treatment adverse Pain, QoL, life years There are clear cost benefits when non-commercial
costs including treatment events, mortality, gained, QALYs systems are used for NPWT, with no evidence of
costs, cost of health re-operation, worsening of clinical outcome, and with lower pain
practitioner time or visits, infections level ratings for non-commercial systems.
cost of hospital stay
QALYs, healing rate, total Amputation rate N/A Patients treated with VAC therapy experienced
cost of care more QALYs (0.787 versus 0.784 for patients
treated with AWC), improved healing rates (50.2%
versus 48.5%) and a lower total cost of care
(€24,881 versus €28,855).
Length of stay, healing N/A N/A NPWT (with STSG) treatment is more effective
success rate after 6 for closure of massive VLUs at 6 months than that
months, estimated costs reported for standard compression therapy. Further,
the cost of NPWT is comparable with standard
compression therapy (estimated $27,000 and
$28,000, respectively).
Time for wound closure N/A N/A Patients receiving NPWT were 2.63 times more
likely to achieve wound closure than patients
receiving standard care. Compared with late NPWT
users, early and intermediate NPWT users were
3.38 and 2.18 times more likely to achieve wound
healing, respectively.
Wound size reduction, N/A Patient blood sugar The custom made VAC system showed good results
time to wound closure stability (diabetes) in healing rate. The study does not report on costs.
Appendix 13. Non-comparative studies
Author Year Country Type of study Study population Intervention
Chaput, N., 2015 France Case-series 23 patients Treatment of acute or chronic
et al. wounds with a specially designed
inexpensive NPWT called
PROVACUUM
Rozen, W. M., 2007 Australia Case-series 9 patients Treatment of lower limb split-
et al. skin grafting with an alternative
method of negative pressure
dressing comprised by a single
cut fom sheet, a conventional
disposable closed-system suction
drain and an adhesive dressing
Searle, R. and 2010 UK Narrative review N/A NPWT in general
J. Milne
Shalom, A., 2008 Israel Case-series 15 patients Treating complex wounds with a
et al. homemade NPWT system
Trueman, P. 2008 US Literature review N/A VAC therapy in home health

settings
Verhaalen, A., 2010 US Case-series 8 patients Wounds with enteroatmospheric

et al. fistulaes, treated with NPWT
supplemented by a impermeable
tubular structure isolating the
fistula
Direct costs Indirect costs Intangible costs Results
Number of dressing Complications Ease of use, pain Surgeons found that the low-cost alternative
changes, length of NPWT device was similar to commercial NPWT
treatment, average devices.
treatment cost
Treatment cost, rate of Complications Patient toleration The cost of five days of treatment with the
skin graft take, length of alternative method of negative pressure dressing
inpatient stay ($577) was significantly lower than the expected
cost of five days of treatment with commercial
VAC dressing ($2603).
Material costs, cost of N/A N/A Evidence suggests that although the unit cost of
nursing time, resources NPWT may be perceived to be high, there is a
used per dressing change real possibility that materials and rental costs can
be offset by, for example, reduction in length of
stay, lower frequency of dressing change, and a
reduction in complications and further surgical
interventions. Further cost-effectiveness studies
are essential.
Cost per day, material Complications N/A The homemade NPWT system obtained results
costs similar to that could be expected with the VAC
(KCI) system in all parameters. Cost per day
using the homemade system for a 10cm2 wound
is about $1, compared with $22 using the VAC
(KCI) system.
Hospitalisation rate, total N/A N/A One of the reviewed studies showed that
cost per healed wound patients treated with NPWT in home care
settings had significantly less hospitalisations.
The overall conclusion is, that the use of NPWT
outside hospital settings has the potential to
improve the efficacy of wound management and
help reduce the reliance on hospital-based care,
which in turn can reduce the overall cost.
Material costs, hospital N/A N/A The technology was successful in isolating the
dischargement rate fistula. Successful isolation of fistulas when using
NPWT has the potential to lower health care
costs by allowing for earlier hospital discharge.
Appendix 14. Flowchart - health economic studies
Pubmed, CINAHL, Scopus Papers for review of

Manual search:
and Web of Science: title and abstract:
71
199 270
Papers excluded:
Inclusion criteria not met: 176
Duplicates: 31
Papers for review of full text:

63
Articles excluded:
No NPWT-specific results: 6
Scientifically invalid results: 9
Articles included in final

evaluation:
48
1. Levels of Evidence Oxford Centre for Evidence based Medicine2009 [Available from: http://www.cebm.net/oxford-centre-
evidence-based-medicine-levels-evidence-march-2009/.
2. Centre for Evidence-Based Medicine. Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009),
www.cebm.net [serial online] 2014; Available from: Centre for Evidence-Based Medicine. Accessed January 23, 2015. 2009

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Abbreviations6 Development of the range of indications: NPWT

• ACS: Abdominal compartment syndrome • FGF-2: Fibroblast growth factor-2

• ABRA: Abdominal re-approximation anchor system • HR: Hazard ratio

• ADR: Acellular dermal replacement • HIF: Hypoxia-induced factor

• bFGF: Basic fibroblast growth factor • IE: Immediate early

• BMI: Body mass index • IM: Intermittent mode

• Cdc42: Cell division control protein 42 • ICU: Intensive care unit

• DFUs: Diabetic foot ulcers • NPWT: Negative pressure wounds therapy

• ECF: Enterocutaneous fistula • NPWTi: NPWT with instillation

• EPUAP: European Pressure Ulcers Advisory Panel • NO: Nitric oxide

• EWMA: European Wound Management Association • OA: Open abdoman

• ERK: Extracellular signal-regulated kinase • PDGF Platelet derived growth factor

• FDA: US Food and Drug Administaration • PHMB: Polyhexamethylene biguanide

• PU: Pressure ulcer

• PHI: Private Health Insurance

• RCTs: Randomised controlled trials

• RR: Relative risk

• SHI: Statutory health insurance

• SSD Silver sulfadiazine treatment

• SSI: Surgical site infections

• SWD: Surgical wound dehiscence

• SDR: Synthetic dermal replacement

• TAC: Temporary abdominal closure

• VEGF: Vascular endothelial growth factor

• WBP: Wound bed preparation

• VEC: vascular endothelial cell

Aim 2. Uncover controversies and issues related to the

Short history Functional principle of NPWT

Fig 1. Principles of NPWT

Conventional NPWT on open wounds causes a

of action ciNPT tissue perfusion, resulting in angiogenesis and the

• ‘Quality’ of the studies under the criteria of

Development of the range of age), under clinically difficult situations (life-

indications: NPWT 1990–2015 threatening abdominal sepsis) and high-risk

acute burns and scalds of suction between −50 mmHg and −200 mmHg.

A nationwide prospective observational study

• Major complications of NPWT, such as severe Lymphocutaneous fistulas

Pressure ulcers ‘This comprehensive review of current randomised

Methods of action When the third phase—the vacuum phase—

NPWTi versus irrigation-suction drainage • Trauma and orthopaedics: High-energy complex

Literature review: randomised trials The most recent meta-analysis performing an

Lateral tension Haematoma and seroma

NPWT, NPWTi, ciNPT

YES • Temporary wound closure

(achieved endpoint) wound debridement and the definitive closure

Table 1. Recommendations for starting and stopping timepoints of NPWT in

Staff competence Family and friends

Family members themselves may also describe being

Organisation of care Short- and long-term goals

NPWT at different levels • Pain management to achieve a reduction in pain

• Does the patient consent to the treatment and is

Implications of cross-sectional ‘The relatively low interest of wounds for many

NPWT doctors can create problems in term of medico-legal

• Communication between care teams and Off-label use

• Inadequate monitoring and ongoing assessment

• Communication and documentation

Abbreviations6 Development of the range of indications: NPWT