International Journal of Surgery 81 (2020) 140–146

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International Journal of Surgery

journal homepage: www.elsevier.com/locate/ijsu

Randomised Controlled Trial

A randomized controlled trial on irrigation of open appendectomy wound

with gentamicin- saline solution versus saline solution for prevention of
surgical site infection
Sameh Hany Emile *, Ahmed Hossam Elfallal , Mohamed Anwar Abdel-Razik , Mohamed El-Said ,
Ayman Elshobaky
General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt

A R T I C L E I N F O A B S T R A C T

Keywords: Background: Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The
Mesh terms): therapeutic irrigation present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical
Surgical wound infection antibiotics in prevention of SSI.
Appendectomy
Methods: This was a double-blind randomized trial on patients with acute appendicitis who underwent open
Gentamicins
Saline solution
appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound
Randomized controlled trial irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III
received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical
site occurrence (SSO), other complications, operation time, postoperative pain, and patients’ satisfaction.
Results: 205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain
scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs
2.9%; Vs 17.4%, p = 0.005) and SSO (24.6% Vs 13.4% Vs 43.5%; p = 0.0003) as compared to group III. Groups I
and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and
dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.
Conclusions: Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO
significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve
the outcome and did not decrease rates of SSI or other complications.

1. Introduction (6.7% vs 4.5%), whereas the incidence of organ/space SSI in both

groups was similar (3%). Another observational study [5] found higher
Acute appendicitis is one of the most common surgical emergencies rates of superficial SSI after open appendectomy (9%) as compared to
in the world with an annual incidence of 10 cases per 100,000 popula­ laparoscopic appendectomy (5%).
tion [1]. While appendicitis complicated with mass or abscess is usually Attempts have been made to reduce the incidence of SSI after ap­
treated conservatively or with ultrasound-guided closed drainage, ap­ pendectomy, one of which was intracavity and wound irrigation with
pendectomy remains the gold standard treatment for acute uncompli­ various solutions. A recent Cochrane review [6] analyzed 59 random­
cated appendicitis [2]. Appendectomy can be performed by the ized controlled trials on different types of surgical wounds, including
traditional open approach or laparoscopically. Complications of ap­ clean, clean contaminated, and contaminated wounds. The trials
pendectomy include surgical site infection (SSI), wound dehiscence, assessed comparisons between irrigation and no irrigation and the irri­
bowel obstruction, abdominal/pelvic abscess, and, stump appendicitis gation groups comprised irrigation with different antibiotics, antisep­
[3]. tics, and non-antibacterial agents. The review concluded that the
A recent study [4] revealed that open appendectomy had higher “evidence base for intracavity lavage and wound irrigation is generally
incidence of overall and incisional SSI than laparoscopic appendectomy of low certainty”.

* Corresponding author. Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.
E-mail addresses: [email protected] (S.H. Emile), [email protected] (A.H. Elfallal), [email protected] (M.A. Abdel-Razik),
[email protected] (M. El-Said), [email protected] (A. Elshobaky).

https://doi.org/10.1016/j.ijsu.2020.07.057
Received 15 June 2020; Received in revised form 3 July 2020; Accepted 21 July 2020
Available online 13 August 2020
1743-9191/© 2020 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
S.H. Emile et al. International Journal of Surgery 81 (2020) 140–146

A large retrospective study [7] compared wound irrigation with • Group I had layer by layer irrigation of the surgical wound with
antiseptic solution, with antimicrobial agent, and with normal saline in gentamicin-saline solution.
patients undergoing open appendectomy and concluded an evident su­ • Group II had layer by layer wound irrigation with normal saline 0.9%
periority of antibiotic wound irrigation over both normal saline and solution.
antiseptic solution. • Group III (Control group) did not receive wound irrigation.
The present trial aimed to assess the efficacy of layer-by-layer wound
irrigation with gentamicin-saline solution versus normal saline solution Simple randomization was achieved by online computer software
in prevention of incisional SSI after open appendectomy for acute (www.randomization.com). Allocation concealment was done by sealed
appendicitis. There were two hypotheses for this trial which are: 1) envelope method as randomly generated treatment allocations were
wound irrigation with saline solution would decrease SSI rates; 2) placed within sealed opaque envelopes. After obtaining patient’s con­
adding topical gentamicin to the irrigation solution would further sent to participate in the trial, an envelope was opened intraoperatively
reduce SSI rates more than simple saline irrigation. and the patient was assigned to the allocated treatment group.
The study was double-blinded since the patients were aware of the
2. Patients and methods nature of the study but not to the group to which they were allocated and
also the outcome assessors were unaware of the treatment groups and
2.1. Study design and setting nature of the study. Conversely, the operating surgeons were aware to
the nature of the study and the allocation of patients to each group since
This was a prospective, double-blinded, randomized controlled trial they performed the irrigation.
on patients with acute appendicitis who were treated with open ap­
pendectomy in the General Surgery Department of our institution in the 2.5. Surgical procedure
period of January 2019 through March 2020. The study took place in
Mansoura University Hospital, which is a tertiary referral center. The After obtaining written informed consents to participate in the trial,
protocol of the study was approved by the Institutional Review Board of the procedures were conducted under general or spinal anesthesia with
our institution. The trial was registered in clinicaltrials.gov registry patients lying in the supine position. Two grams of cefotaxime and 500
under identifier NCT04332809. This study has been reported in line mg of metronidazole were given on induction as antibiotic prophylaxis
with the Consolidated Standards of Reporting Trials (CONSORT) in accordance with Surgical Care Improvement Project protocol. All
Guidelines. procedures were done by the open approach by three surgical residents
with similar level of experience under supervision of consultants of
general surgery.
2.2. Eligibility criteria After preparation of the skin with povidone iodine solution, a clas­
sical grid iron incision was made and the external oblique aponeurosis
The study included patients of either gender aged between 16 and 65 was divided along its fibers, followed by splitting of the internal oblique
years who presented to the emergency department with acute appen­ and transversus abdominis muscles and opening of the peritoneum. The
dicitis. Acute appendicitis was diagnosed by clinical examination and appendix was delivered through the incision and ligation and division of
intraoperative findings and the diagnosis was confirmed by histopath­ the mesoappendix was done. Next, the base of the appendix was crushed
ologic examination of the removed appendix. by a Kocher forceps and double ligatures were placed to secure the base
We excluded patients with appendicular mass, appendicular abscess, of the appendix followed by division and removal of the appendix.
appendicitis associated with generalized peritonitis, acute abdomen due Peritoneal toilet was performed using dry gauze then the peritoneum
to other causes as revealed intraoperatively, patients with normal ap­ was closed with running polyglactin 3/0 sutures.
pendix as revealed intraoperatively and after histopathologic examina­ In group I, upon closure of the peritoneum gentamicin-saline solu­
tion, patients taking long course of steroid therapy or tion (160 mg of gentamicin in 400 ml of normal saline 0.9%) was used
immunosuppressive treatment, and patients unwilling to participate in by a 20-cm syringe for irrigation of every layer of the wound before its
the trial. closure. The first layer was between the peritoneal membrane and the
internal oblique muscles, the second layer was between the approxi­
mated internal oblique muscles and the external oblique aponeurosis,
2.3. Preoperative assessment
and finally the third layer (the subcutaneous space) after closure of the
external oblique aponeurosis (Fig. 1). In group II, layer by layer irriga­
Detailed history was taken from the patients with regards to the
tion of the wound with normal saline solution was performed in a similar
onset and duration of the complaint, previous investigations and treat­
manner. In group III, layer-by-layer closure of the surgical wound with
ments received, medical comorbidities, and previous surgeries. Thor­
polyglactin 2/0 sutures took place without irrigation. All patients in the
ough clinical examination was undertaken including vital sign
three groups had layer-by-layer wound closure in a standardized manner
assessment, abdominal examination to confirm clinical signs of acute
to avoid the risk of bias. In the case of heavy wound contamination, the
appendicitis and exclude any palpable masses. Complete blood count,
fascial and muscle layers only were closed and delayed closure of the
urine analysis, and abdominal ultrasonography were performed. In
skin was undertaken after a few days.
addition, pregnancy test was ordered for female patients in the child-
bearing period. CT scanning was requested in select patients to
exclude presence of appendicular mass/abscess or other abdominal
pathologies. The general condition of the patients was assessed using the
American Society of Anesthesiologists (ASA) status classification system
[8].

2.4. Generation of the random sequence and blinding

Randomization was carried out at the time of surgery just before

closure of the peritoneum. Patients were randomly allocated to one of
three equal groups: Fig. 1. Diagram demonstrating layer-by-layer irrigation of the surgical wound.

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2.6. Postoperative care at 5%. In order to compensate for loss to follow-up and drop-outs, a total
of 204 patients were required to be recruited.
Patients were monitored in the general ward. Vitals signs and output
of drain (if present) were assessed regularly. One gram of cefotaxime 2.10. Statistical analysis
was administered intravenously within 12 h after closure of the incision.
Proper analgesia was achieved by diclofenac sodium I.V. 50 mg on pa­ Data were analyzed by SPSS version 23 (IBM corp; Chicago, USA).
tients’ demand. The normality of data distribution was examined by the Kolmogorov-
Smirnov (K–S) test. Continuous data were expressed as mean (stan­
2.7. Follow-up dard deviation (SD)) or median and range. Categorical variables were
expressed as number and proportions. Student t-test or Anova one-way
Follow-up of patients was conducted in the surgery outpatient clinic was used to process continuous data and Fisher exact test or Chi
at 1, 2, 4, and 6 weeks after surgery. Assessment of the outcome of square test was used for processing categorical variables. A per protocol
surgery was made by a surgical resident and consultant of general sur­ approach was used for data analysis.
gery who both were not involved in the study and were unaware to the Post-hoc test for Anova analysis was used if a statistically significant
group allocation. At each visit, wound healing was assessed, and wound difference in the continuous variables was detected between the three
complications were recorded, including SSI, wound collection (seroma), groups. Post-hoc test for Chi-Square test was used if a statistically sig­
hematoma, cellulitis, necrosis, fistula, and dehiscence. In the case SSI nificant difference in the categorical variables was detected between the
was detected, wound swab and culture were taken to identify the three groups.
causative organism and determine the most effective antibiotic against P values less than 0.05 were considered significant. Reporting of
which. significant p values was as follows: when p was larger than 0.01 it was
Pain at the site of the incision was evaluated at one week with visual reported with two decimal places, when p was between 0.01 and 0.001 it
analogue scale (VAS) from 0 to 10 where zero implies absence of pain was reported with three decimal places, and when p was less than 0.001
and 10 indicates the worse severe pain. Patients’ satisfaction with the it was reported as <0.001.
procedure was evaluated by a simple questionnaire at six weeks after
surgery. Patients were asked if they were completely satisfied, partly 3. Results
satisfied, or unsatisfied with the outcome of their surgery and the causes
of dissatisfaction were inquired. The outcome assessment was made by 3.1. Characteristics of the entire cohort
independent surgeons who were unaware of the nature of the study and
group allocations. After initial screening of 261 patients with acute appendicitis, 36
patients did not meet the study criteria and were excluded whereas 225
2.8. Outcomes of the study patients were recruited to the study. We excluded 10 patients who were
found to have normal appendix or other diagnoses intraoperatively
The primary outcome of the study was the incidence of incisional SSI (normal appendix = 5, complicated ovarian cyst = 3, Meckel’s diver­
in both groups. SSI was defined according to the standard criteria ticulitis = 1, pelvic inflammatory disease = 1). Among 215 patients who
devised by the center for disease and control (CDC) [9]. Purulent underwent the intervention, 10 were lost to follow-up, thus 205 patients
drainage from the wound, cellulitis requiring antibiotics, or the opening were ultimately analyzed. The process of patients’ recruitment and
of a closed wound were considered criteria of Incisional SSI. exclusion is illustrated in the Consort flow chart (Fig. 2).
Secondary outcomes included. Patients were 113 (55.1%) female and 92 (44.9%) male. The mean
age of patients was 27.9 (SD 8.7) (range, 16–58) years. Eight (3.9%)
• Surgical site occurrence (SSO) which comprised SSI, cellulitis, ne­ patients had medical comorbidities (Diabetes mellitus = 4, hyperten­
crosis, chronic and/or non-healing wound, serous or purulent sion = 3, chronic liver disease = 1). All patients had ASA I status, except
drainage, seroma (pocket of sterile clear serous fluid at the site of the seven (3.4%) patients who had ASA II status.
incision), hematoma (collection of blood or clots in the surgical The average preoperative temperature was 37.6 (SD 0.95) (range,
wound), wound dehiscence, or fistula at the surgical site [10]. 36.5–40) Celsius and the mean total leucocyte count (TLC) was 13.4 (SD
• Other complications including intra-abdominal abscess, ileus, bowel 7.3) (range, 4–22.5). Forty-eight (23.4%) patients had a minimal
obstruction, intestinal fistula, and adverse effects related to the sys­ amount of free fluid in the pelvis. CT scanning was performed in 32
temic absorption of gentamicin. An intra-abdominal abscess was (15.6%) patients. Fifteen (7.3%) patients presented with gangrenous
defined as an intra-abdominal fluid collection that contained puru­ appendicitis. According to the classification of wound contamination,
lent material [7]. 143 (69.8%) patients had class II wounds and 62 (30.2%) had class III
• Operation time in minutes. wound.
• Hospital stay in days. Sixty-nine patients were allocated to group I (irrigation with
• Visual analogue pain score. gentamicin-saline), 67 were allocated to group II (irrigation with saline),
• Patients’ satisfaction. and 69 were allocated to group III (no irrigation). There were no sig­
nificant differences between the three groups in regards patients’ de­
2.9. Sample size calculation mographics, ASA status, preoperative temperature, TLC,
ultrasonographic findings, and wound class as shown in Table 1. None of
The sample size for this trial was based on the primary endpoint of the patients in either groups required delayed skin closure.
the study (incidence of incisional SSI within 6 weeks postoperatively). A
systematic review [11] revealed that the pooled, weighted rate of SSI 3.2. Outcome of both groups
after appendectomy performed in low and middle human development
index (HDI) countries is 17.9% (95%CI: 10.4–25.3%). We assumed that The average operation time was significantly (p < 0.001) longer in
the rate of SSI after wound irrigation with gentamicin-saline solution group I [55.1 (SD 8.7)] and group II [55.6 (SD 8.2)] as compared to
will be 5% versus 18% after closure of the wound without irrigation. group III [50.2 (SD 8.2)] minutes. The mean duration of hospital stay
Using sample size calculation software (https://clincalc.com/stat was comparable between the three groups [1.1 (SD 0.26) Vs 1.05 (SD
s/samplesize.aspx) a minimum of 186 patients, equally divided on the 0.24) Vs 1.14 (SD 0.3)] days; p = 0.18).
three groups, was needed to achieve a study power of 80% with alpha set Groups I and II had significantly lower rates of incisional SSI than did

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Fig. 2. Consort flow chart.

Table 1
Perioperative patients’ characteristics in the three groups.
Variable Gentamicin-saline (N = 69) Saline (N = 67) No irrigation (N = 69) P value

Mean age in years 26.9 (SD 7.7) 29.6 (SD 9.9) 26.9 (SD 8.4) 0.09
Male/Female 28/41 30/37 34/35 0.57
Medical comorbidities Diabetes Mellitus (%) 1 (1.4) 3 (4.5) 0 0.12
Hypertension (%) 2 (2.8) 1 (1.5) 0 0.54
Chronic liver disease (%) 0 0 1 0.99
ASA status I (%) 68 (98.5) 64 (95.5) 66 (95.6) 0.63
II (%) 1 (1.5) 3 (5.5) 3 (4.3)
Mean temperature in Celsius 37.5 (SD 0.6) 37.4 (SD 1.4) 37.7 (SD 0.7) 0.29
Mean total leucocyte count (x 109/L) 12.9 (SD 3.8) 12.2 (SD 3.4) 13.6 (SD 3.7) 0.07
Free fluid in ultrasound 18 (20.1) 10 (14.9) 20 (28.9) 0.11
Patients with gangrenous appendicitis (%) 4 (5.8) 6 (8.9) 5 (7.2) 0.71
Class of wound contamination I (%) 0 0 0 0.19
II (%) 47 (68.1) 52 (77.6) 44 (63.7)
III (%) 22 (31.9) 15 (22.4) 25 (36.3)
IV (%) 0 0 0

group III (4.3% Vs 2.9% vs 17.4%; p = 0.005). On subgroup analysis, group III (24.6%Vs 43.5%, p = 0.03). Similarly, group II was followed by
group I had a significantly lower SSI rate than group III (4.3% Vs 17.4%, a significantly lower SSO rate than group III (13.4% Vs 43.5%, p =
p = 0.02) and group II had significantly lower SSI rate than group III 0.0002). Group I and group II had comparable rates of SSO with no
(2.9% vs 17.4%, p = 0.009). Both groups I and II had comparable rates of significant difference (p = 0.15). The three groups had similar rates of
SSI (4.3% Vs 2.9%) with no significant difference (p = 0.99). wound seroma (17.4% Vs 8.9% vs 21.7%; p = 0.11), hematoma (2.8%
Groups I and II were followed with significantly lower rates of SSO Vs 1.5%; vs 1.4%; p = 0.84), and dehiscence (0% Vs 0% Vs 2.8%; p =
than did group III (24.6% Vs 13.4% Vs 43.5%; p < 0.001). On subgroup 0.22) (Table 2).
analysis, group I was followed by a significantly lower SSO rate than Other complications were recorded in six patients; two in group I

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Table 2 Table 3
Outcome of the three groups. Patient-reported outcomes of the three groups.
Variable Gentamicin- Saline No irrigation P value Variable Gentamicin- Saline No P value
saline (N = 69) (N = 67) (N = 69) saline (N = (N = irrigation
69) 67) (N = 69)
Mean operation 55.1 (SD 8.7) 55.6 (SD 50.2 (SD 8.4) <0.001
Pain visual analogue score 4.04 (SD 1.4) 3.68 4.13 (SD 0.83
time in minutes 8.2)
(SD 1.6)
Surgical site 3 (4.3) 2 (2.9) 12 (17.4) 0.005
1.2)
infection (%)
Satisfaction Satisfied 52 (75.3) 59 (88) 41 (59.4) <0.001
Seroma (%) 12 (17.4) 6 (8.9) 15 (21.7) 0.11
(%)
Hematoma (%) 2 (2.8) 1 (1.5) 1 (1.4) 0.84
Partly 12 (17.4) 6 (9) 13 (18.8)
Wound dehiscence 0 0 2 (2.8) 0.22
satisfied
(%)
(%)
Total surgical site 17 (24.6) 9 (13.4) 30 (43.5) <0.001
Unsatisfied 5 (7.2) 2 (3) 15 (21.7)
occurrence (%)
(%)
Other 2 (2.8) 3 (4.4) 1 (1.4) 0.45
complications (%)
Mean hospital stay 1.1 (SD 0.26) 1.05 (SD 1.14 (SD 0.3) 0.18
in days 0.24)
4. Discussion

SSI is one of the common complications of surgery and remains a

(urine retention = 1, ileus = 1), three in group II (urine retention = 2 and significant healthcare problem despite the recent advances in surgical
ileus = 1), and one in group III (urine retention = 1) with no significant technology and antibiotic development. Every effort should be made to
difference between the three groups (p = 0.45). None of the patients reduce the incidence of SSI after surgery as it is usually associated with
developed intra-abdominal abscess, bowel obstruction, or intestinal additional morbidity to the patients and higher costs [12].
fistula postoperatively. No adverse effects related to the use of genta­ In the present trial we investigated the efficacy of layer-by-layer
micin were recorded. irrigation of open appendectomy wound in the prevention of inci­
sional SSI. Although laparoscopic appendectomy has become the stan­
3.3. Post-hoc analysis of study outcomes dard of care for acute appendicitis in numerous centers and hospitals
around the world, open appendectomy still has its place in the resource-
Using post-hoc test for Anova analysis of the mean operation time of limited communities where access to minimally invasive surgery in the
the three groups, the F Statistic was 8.44, with significant p value < emergency setting may not be feasible. This has been affirmed in a
0.001. On running post-hoc Tukey HSD test to establish the difference recent multicenter study that found open appendectomy accounts for
between each two groups, Group I had longer operation time than group more than 90% of total appendectomies performed in low- and middle-
III (p = 0.002), Group II had longer operation time than group III (p = income countries [13].
0.001), whereas groups I and II had similar operation time (p = 0.89). We hypothesized that each layer of the surgical wound may be prone
We ran a post-hoc test for Chi-square analysis of the rates of SSI in the to bacterial contamination during delivery of the appendix through the
three groups. The Bonferroni correction was set at default P value/ McBurney’s incision. Hence, we suggested that irrigation of each layer of
number of comparisons (0.05/3 = 0.017). Hence, the significance level the wound separately with antibiotic-saline solution or saline solution
of the post-hoc test was set at p < 0.017. The Chi-Square statistics of the may eradicate any potential contamination of each layer, thus reduce
post-hoc test was 11.4 with significant p value of 0.003. Subgroup the incidence of superficial and deep incisional SSI.
analysis revealed that group I had lower SSI rate than group III yet In order to test this hypothesis, we conducted this randomized trial
without reaching statistical significance according to the Bonferroni which compared patients who received irrigation of the wound with
adjustment (p = 0.02). Conversely, group II had significantly lower SSI either gentamicin-saline or normal saline solution and patients who did
rate than group III (p = 0.01). Both groups I and II had similar rates of not have irrigation. We chose gentamicin as the antibiotic used for
SSI (p = 0.67). irrigation because it is an Aminoglycoside antibiotic that is particularly
potent against bacteria of the Enterobacteriaceae family, including
3.4. Management of wound-related complications Escherichia coli and Enterococcus, which are the most common organ­
isms causing SSI after appendectomy [14–16]. As compared to other
Overall, 17 patients experienced incisional SSI (superficial = 15, antibiotics covering the same group of organisms, gentamicin is readily
deep = 2), all patients were treated with antibiotics based on the results available at a lower cost. Furthermore, gentamicin has documented
of culture and sensitivity tests. In addition, five (29.4%) patients benefits in reducing the volume of drainage and wound contamination
required drainage of the infected surgical wound. in other wounds such as axillary dissection and episiotomy wounds [17,
Patients who developed wound seroma (n = 33) and wound hema­ 18].
toma (n = 4) were treated with removal of one stitch and evacuation of The results of this trial asserted our assumption as less than 5% of
the collected fluid under antibiotic coverage. Two patients developed patients who received wound irrigation developed incisional SSI,
superficial wound dehiscence secondary to SSI and were treated with significantly less than the non-irrigation group in which almost 18% of
daily dressing until complete healing by secondary intention was the patients experienced SSI. While the rate of incisional SSI in the non-
achieved. irrigation group may seem exceedingly high as compared to the Western
literature, it should be highlighted that the rates of SSI after open ap­
pendectomy may differ substantially between low and middle-income
3.5. Patient-reported outcomes
and high-income countries. A recent systematic review reported a
pooled SSI rate of 17.9% after open appendectomy in low and middle-
The three groups had comparable postoperative pain scores [4.04
HDI countries, close to the SSI rate recorded in the non-irrigation
(SD 1.4) Vs 3.86 (SD 1.2) Vs 4.13 (SD 1.6); p = 0.83]. Overall, 92.8% of
group of this study. This was replicated in another large multicenter
group I patients and 97% of group II patients were completely or partly
study [19] that reported the incidence of SSI after gastrointestinal
satisfied with the outcome of their procedure, significantly (p < 0.001)
resection, including appendectomy, to be 9.4%, 14%, and 23.2% in
higher than group III patients (78.2%) (Table 3). Patients’ dissatisfaction
high, middle, and low HDI countries.
was mainly attributed to postoperative wound-related complications
On comparing irrigation with gentamicin-saline and with saline
and related interventions.

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only, no significant difference in the SSI rate was observed. This cor­ income countries where open appendectomy is still prevalent, but also
roborates the notion that irrigation per se may be sufficient to reduce the in high-income countries when conversion to open appendectomy is
rates of SSI after clean-contaminated and contaminated procedures. Our inevitable or when there are contraindications to laparoscopic appen­
findings go in line with a meta-analysis of randomized trials [20] that dectomy such as extensive adhesions, radiation, immunosuppressive
found no significant effect of antibiotic irrigation of the wound on the therapy, severe portal hypertension, coagulopathies, and during the first
rate of incisional SSI as compared to no irrigation or normal saline trimester of pregnancy [29]. Hence, surgeons who have to do open ap­
irrigation. However, this meta-analysis comprised different types of pendectomy either because of lack of resources, presence of contrain­
procedures, including bariatric, vascular, and colorectal procedures dications to laparoscopy, or as a conversion due to technical difficulties
[21–24] whereas our trial exclusively involved clean-contaminated and may benefit of our findings by employing wound irrigation to minimize
contaminated wounds of appendectomy. the rates of SSI.
A randomized controlled trial [25] assessed the role of intrainci­ This trial is not without limitations which include being a single-
sional irrigation with topical cefotaxime in contaminated abdominal center trial with short-follow-up. However, since the primary outcome
surgery and also failed to find a beneficial impact of wound irrigation of the trial (SSI rate) was adequately assessed within the follow-up
with topical antibiotic on reducing the rates of SSI in patients with duration, longer follow-up may not be required. In order to substanti­
peritonitis at the time of abdominal surgery. ate the findings of this trial, further multicenter trials comparing irri­
In contrast, a large retrospective series [7] documented significantly gation with gentamicin-saline solution and irrigation with saline only
lower rate of SSI after wound irrigation with antimicrobial solution are required.
(imipenem) than after irrigation with normal saline and Dakin’s solu­
tion. This goes against the findings of the present trial and can be 5. Conclusions
explained by the retrospective nature of the study, being associated with
selection bias, and also to the difference in the topical antimicrobial Layer-by-layer irrigation of the open appendectomy wound with
agent used. It is worthy to note that while the retrospective study saline solution, whether a topical antibiotic was used or not, effectively
employed intra-abdominal irrigation, the present trial used decreased the rates of incisional SSI and SSO as compared to no irriga­
layer-by-layer irrigation of the surgical incision without intra-cavitary tion. The addition of topical gentamicin to saline solution was useless to
irrigation. improve the outcome as it did not confer any tangible reduction in the
Former studies found irrigation of appendectomy wound with topical rates of SSI and SSO as compared to irrigation with normal saline only.
antimicrobial solution effectively reduced the incidence of SSI. Al-
Shehri et al. [26] concluded that irrigating the appendectomy wound Ethical approval
with topical ampicillin in addition to systemic administration of
gentamicin and metronidazole augmented prophylaxis against SSI in Institutional review board of Mansoura Faculty of Medicine.
acute appendicitis. Similarly, Marti & Moser [27] randomized 162 pa­ Code: R/18.12.357.
tients undergoing appendectomy to either wound irrigation with saline
alone or irrigation with saline and ampicillin/lincomycin and found a Sources of funding
statistically significant smaller incidence of SSI in the antibiotic group
than in the saline only group. None.
The rates of other wound-related complications were similar in the
three groups, with comparable rates of wound seroma, hematoma, and Author contribution
dehiscence. Nonetheless, the overall rates of SSO in the irrigation groups
were significantly lower than the non-irrigation group owing to the Sameh Emile designed the study, shared in data collection and anal­
lower incidence of SSI in the irrigation groups. Again, adding gentamicin ysis and writing the manuscript.
to saline solution did no confer additional benefit over normal saline Ahmed Hossam Elfallal contributed to data collection and analysis
only as both groups had similar rates of SSO. and writing of the manuscript.
While gentamicin solution has been reported to reduce the volume of Mohamed Abdel-Razik contributed to data acquisition and analysis
wound drainage in other wounds such as the axillary dissection bed and revising the manuscript.
[17], it did not reduce the incidence of wound seroma significantly in Mohamed El-Said contributed to data analysis, drafting and critical
this trial. The irrigation with either gentamicin-saline or saline solution revision of the manuscript.
required longer operation time than the non-irrigation group. Although Ayman Elshobaky contributed to data interpretation and analysis and
the difference in the operation time (5 min) was statistically significant, revision of the manuscript.
it may not be clinically relevant as well.
With growing interest in patient-reported outcomes [28] as an Trial registry number
important measure of the success of surgery, we assessed two
patient-centered outcomes: pain and overall satisfaction. While the Registry used: clinicaltrials.gov.
three groups had similar pain scores, the irrigation groups had much Registration ID: NCT04332809.
higher patients’ satisfaction than the non-irrigation group. On querying Hyperlink to specific registration: https://clinicaltrials.gov/ct2/sh
the reasons for dissatisfaction, patients considered the development of ow/NCT04332809.
wound-related complications with the need for additional interventions
such as wound drainage to be the leading cause of their discontent. Guarantor
Although previous studies examined the efficacy of different topical
antibiotics, these antibiotics were mostly imipenem, cefotaxime, and Sameh Emile, M.D.
ampicillin whereas we used gentamicin. Also, we used the layer-by-layer
irrigation technique which is the first time to be described in the liter­ Data statement
ature whereas the previous studies used either intracavitary irrigation or
simple irrigation of the subcutaneous space only. Research data used in the study will be available on request.
Finally, as aforementioned most appendectomies are performed
laparoscopically in the high-income countries. However; our findings
may be relevant not only for surgeons practicing in the low-and middle-

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S.H. Emile et al. International Journal of Surgery 81 (2020) 140–146

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