Surgery 174 (2023) 291e295

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Surgery
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Negative pressure wound therapy versus standard care for incisional

laparotomy subcutaneous wounds in gastrointestinal perforations:
A randomized controlled study
Harjeet Singh, MCha,*, Mohanasundaram Avudaiappan, MCha, Jyoti Kharel, MSa,
Santosh Irrinki, MSb, Hemant Kumar, MChc, Ajay Savlania, MChb, Vishal Sharma, DMd,
Vikas Gupta, MCha, Thakur Deen Yadav, MSa, Rajesh Gupta, MCha
a
Department of Surgical Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
b
Department of General Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India
c
Department of Surgical Gastroenterology, Manipal Hospital, Bangalore, India
d
Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India

a r t i c l e i n f o a b s t r a c t

Article history: Background: Surgical site infections after gastrointestinal perforation with peritonitis have significant
Accepted 9 April 2023 morbidity, increased hospital stays, and cost of treatment. The appropriate management of these wounds
Available online 12 May 2023 is still debatable.
Methods: Patients undergoing surgery for gastrointestinal perforation with peritonitis via midline inci-
sion were screened for inclusion. After the closure of the midline fascia, patients were randomized into
an open negative pressure wound therapy group (application of negative pressure wound therapy and
attempted delayed closure at day 4) or a standard care group (no negative pressure wound therapy and
attempted delayed closure at day 4). Postoperative outcomes, including surgical site infection till 30 days,
were compared between the groups. This was assessed by an independent assessor not involved in the
study for delayed closure. Although a priori sample size was calculated, an interim analysis was per-
formed due to slow recruitment during the COVID pandemic. After interim analysis, a continuation of the
trial was deemed unethical and terminated.
Results: Ninety-six patients were assessed, and 69 were randomized (34 in the negative pressure wound
therapy group and 31 in the standard care group). The age, body mass index, comorbidities, blood loss,
operative time, and stoma formation were comparable. The surgical site infection was significantly lower
in the negative pressure wound therapy group compared to the standard care group (6 [18%] vs 19 [61%],
P < .01). The number needed to prevent 1 surgical site infection was 2.3. In a subgroup analysis, the use of
negative pressure wound therapy also significantly decreased the rate of surgical site infection in stoma
patients (4 [30.7%] vs 9 [69.3%], P ¼ .03).
Conclusion: Open negative pressure wound therapy significantly decreases the incisional surgical site
infection rate in patients with a dirty wound secondary to gastrointestinal perforation with peritonitis.
© 2023 Elsevier Inc. All rights reserved.

Introduction viscus GIP are classified as class IV (dirty wound) surgical sites
according to Centers for Disease Control and Prevention guide-
Wound infection after abdominal laparotomy for gastrointes- lines.2 These wounds are at an increased risk of complications due
tinal perforation with peritonitis (GIP) significantly impacts health to the patients' high bacterial load and associated poor functional
resources and the cost of care.1 The surgical wounds of hollow and nutritional status. The incidence of surgical site infections (SSI)
in these wounds is high, reported to be 40% to 50%.3,4
Various methods have been described for the closure of these
* Reprint requests: Harjeet Singh, Associate Professor, Department of Surgical
types of wounds to decrease SSI. Closure by secondary intention
Gastroenterology, Post Graduate Institute of Medical Education and Research,
Chandigarh 160012, India. improves SSI but comes at the cost of increased morbidity and
E-mail address: harjeetsingh1982@[Link] (H. Singh); hospital stay. Delayed primary closure (DPC) is used in contami-
Twitter: @harjeetsinghpgi nated wounds with an increased risk of SSI. Such wounds are left

[Link]
0039-6060/© 2023 Elsevier Inc. All rights reserved.
292 H. Singh et al. / Surgery 174 (2023) 291e295

open for a few days and planned for closure at a later date once leakage from the NPWT dressing was changed or corrected
deemed fit. Delayed primary closure can reduce SSI over early immediately. After 4 days of NPWT, the dressing was removed and
primary closure. A study by Cohn et al demonstrated a wound replaced by an ordinary sterile gauze dressing.
infection rate of 12% in delayed primary closure compared to 48% in In group 2 (the standard care group), routine wound care was
the primary closure group.4 However, few other studies failed to provided in accordance with local institute standards. This included
demonstrate the advantage of DPC over primary closure.5,6 There is washing the wound with normal saline and dressing using sterile
no unanimity in managing these types of complex wounds. gauze daily. The first dressing change was done after 24 hours and
The literature on negative pressure wound therapy (NPWT) in then once daily or more frequently, depending on the condition of
surgical wounds other than abdominal wounds is abundant. Sig- the wound.
nificant improvement in wound healing and a lower SSI rate with In both groups, dressing changes were performed at the bedside
NPWT have been shown.7e9 The benefit of NPWT has been of inpatient wards or the intensive care unit and were not per-
demonstrated for GIP wounds in a few observational studies.10,11 formed under sedation or anesthesia. Moreover, before this study,
Because of the lack of direct comparison vis- a-vis standard care, our institute did not routinely use routine NPWT dressings for GIP
we conducted a randomized study to assess the efficacy of NPWT in wounds.
the laparotomy wounds of patients with GIP in decreasing wound
infections and earlier closure of the wound.
Outcome assessment
Methods
The study's primary endpoint was the development of the
incisional SSI within 30 days of surgery. An independent clinician
Study design
blinded to the study groups and not involved in these patients'
surgery and routine care assessed the wound in both arms for DPC
We conducted a parallel arm single-center randomized control
on postoperative day 4. The NPWT dressing was removed and
trial with a 1:1 allocation ratio. The study was conducted at the
replaced with standard dressing before showing it to the inde-
Department of Surgical Gastroenterology in a tertiary care institute
pendent clinician. The suturing was done immediately if the wound
in northern India between July 2018 and July 2021. The institutional
was suitable for closure or if the closure was delayed for unsuitable
ethical committee approved the study, and it was registered pro-
wounds, and the wounds were assessed daily for closure by the
spectively with the clinical trial registry of India (CTRI/2018/08/
same clinician. The outcome assessors involved in the wound
015489). The study was conducted in line with the Declaration of
assessment for wound closure were experienced clinicians who
Helsinki and Indian Council of Medical Research guidance. Written
were given standard criteria and instructions for wound closure (no
informed consent was obtained before inclusion. Consecutive adult
evidence of purulent discharge, spreading cellulitis, and intact
patients with GIP planned for surgery via midline incision were
facia). The delayed primary closure was done under local anesthesia
screened for inclusion in the study. Patients with prior laparotomy,
using 2-0 polyamide sutures with aseptic precautions. The wound
perforation with a localized collection, patients on inotropic sup-
was inspected daily in the wards for admitted patients and in the
port or mechanical ventilation even after resuscitation before sur-
outpatient department if the patient had come for follow-up. The
gery, and those denying consent were excluded.
patients were observed for SSI after delayed primary closure. Su-
perficial SSI (skin and subcutaneous) and deep SSI (fascia and
Study protocol
muscle layer) were defined as infection during hospitalization or
within 30 days of surgery with at least 1 of the following: purulent
Preoperative care and surgical methods
drainage from the surgical wound; signs and symptoms of infection
All patients were resuscitated and optimized with intravenous
(pain, redness, swelling) requiring the opening of the surgical
fluids and broad-spectrum antibiotics before surgery. Clinico-
wound; wound dehiscence; or an abscess involving the deep inci-
demographic variables and preoperative laboratory parameters
sion.12 If there was any wound infection after secondary closure, the
were recorded.
wound was opened and managed with daily dressing in both
All patients were operated under general anesthesia. Skin
groups. The secondary outcomes were duration of wound closure
preparation was done by clipping at the time of surgery. Chlor-
from surgery, complete wound healing time (either by primary
hexidine solution will be used as a disinfectant before incision. The
intention or secondary intention), fascial dehiscence, and total
choice of procedure (primary repair, resection, anastomosis, or
hospital stay. All patients were followed for at least 90 days after
stoma formation) for disease pathology was at the surgeon’s
surgical intervention in the outpatient department.
discretion based on clinical indication. After source control, thor-
ough peritoneal lavage with warm normal saline was performed
until the effluent was clear. Peritoneal drains were placed according
to the surgeon’s preference. The midline fascia was closed with Allocation concealment and randomization
monofilament polydioxanone suture material. All patients’ skin The patients were randomized and assigned (1:1) to the NPWT
wounds were washed thoroughly with normal saline and a 5% (group 1) and standard care (group 2) groups using a computer-
povidone-iodine solution. The skin and subcutaneous tissue were based randomization program. The random permuted block
left open. design was used for randomization with computer-generated
random numbers. Randomization was done after the closure of
Intervention the midline fascia. The allocation concealment was ensured using
Randomization was conducted after the closure of the midline serially numbered opaque sealed envelopes. Personnel not
fascia. The NPWT (KCI [Link] Negative Pressure Wound Therapy involved in the conduct of the study generated randomization
System) was applied to group 1 immediately after the completion sequence and allocation concealment. The envelopes were kept
of surgery. The edges of the dressing were reinforced with self- locked and opened only just before the laparotomy closure after a
adherent tape to ensure an airtight seal. At this stage, the vacuum decision to randomize had been made. Blinding was not done
unit was attached to create negative pressure. The NPWT group for the participant, surgeon, and care provider, but the outcome
maintained continuous pressure of 120 mm Hg for 4 days. Any assessors were masked.
 H. Singh et al. / Surgery 174 (2023) 291e295 293

Figure 1. Consort flow diagram.

Sample size 2 patients, perforation was not identified. Finally, 69 were ran-
The sample size was calculated with a 2-sided significance and a domized. After randomization, 4 patients were excluded from the
power of 80%. The expected incidence of wound infection was 20% final analysis. Two patients from the standard care group and 1
in the control group and 3% in the study group. The expected patient from the NPWT group expired before the first assessment.
attrition rate was 15%. Based on this, the required sample size was One patient from the standard care group required re-exploration
calculated to be 154. However, due to the COVID-19 pandemic, the before the first assessment (Figure). Of the 65 remaining patients
recruitment of patients was slow; by April 2021, 69 patients had in the final analysis, 34 were in the NPWT, and 31 were in the
been randomized. An interim analysis showed that the intervention standard care group. The mean age of the study population was 35
arm (NPWT) fared much better and that it would be unethical to ± 16 years. Fifty-two (80%) patients were male; the mean body
continue randomizing patients; thus, the trial was halted. mass index (BMI) was 22.7± 3.8 kg/m2. Twenty-two (34%) patients
were smokers. The site of perforation was small bowel in 29
Statistical analysis (44.6%), peptic ulcer perforation in 29 (44.6%), colon 5 (7.7%), and
appendix 2 (3.1%). The median operating time was 150 (IQR 60)
Statistical analysis was performed using IBM SPSS, version 25 minutes. Twenty (31%) patients required stoma as part of their
(IBM SPSS, Inc, Armonk, NY). We did an intention-to-treat analysis. procedure. (Supplementary Table S1). The demographic, preoper-
Continuous variables were reported as a mean and SD or median ative, and operative characteristics were similar between the 2
and IQR, as deemed appropriate, and the categorical variable was groups (Table I).
expressed as frequency and percentage. Mann- Whitney U test was
employed to compare a continuous variable between 2 indepen- Postoperative complications and outcomes
dent groups at a particular time. For comparing categorical vari-
ables at a particular time, the c2 analysis was employed if the Primary outcome
expected value in all cells inside the contingency table was >5; Overall, 25 patients (38.5%) developed incisional SSI (19 in the
otherwise, the Fisher exact test was employed. The odds ratio and no NPWT group and 6 in the NPWT group). The incidence of su-
95% CI were computed for the categorical variables. In addition, the perficial and deep SSI in the no NPWT group was 25.8% and 35.5%,
number needed to treat was computed for the primary outcome respectively, and in the NPWT group, it was 8.8% each (Table II). The
variable. rate of SSI was significantly higher in the no NPWT group compared
to the NPWT group (19 [61%] vs 6 [18%], P < .01). The number
Results needed to treat to prevent 1 SSI was 2.3.

Study population Secondary outcome

Delayed primary closure was achieved in 46 (71%) patients,
Ninety-six patients were assessed for inclusion. Twenty-one which was significantly higher in the NPWT group (31 [91%] vs 15
patients were excluded after preoperative evaluation (17 patients [48%], P < .01]). The median duration from surgery to delayed
were on preoperative inotropic support or mechanical ventilation, primary closure was 4 days in the NPWT group and 5 days in the
2 had previous midline laparotomies, and 2 denied consent). Six standard care group. The fascial dehiscence occurred in 18 patients,
patients were excluded during surgery due to the formation which was significantly higher in the standard care group (15 [48%]
of distal mucus fistula in midline wounds in 4 patients, and in vs 3 [9%], P < .01). The median duration of complete wound healing
294 H. Singh et al. / Surgery 174 (2023) 291e295

Table I
Demographics, comorbidities, and operative details of 2 allocation groups

Total (65) NPWT group (34) Standard care group (31) P value

Age, mean ± SD, y 35 ± 16 37 ± 15 33 ± 17 .37

Sex, male, n (%) 52 (80) 26 (77) 26 (84) .45
BMI, mean ± SD, kg/m2 22.7 ± 3.8 23.2 ± 4.0 22.2 ± 3.6 .29
Hypertension, n (%) 2 (3) 1 (3) 1 (3) .94
Smoking, n (%) 22 (34) 13 (38) 9 (29) .43
Operative time, median (IQR), min 150 (120,180) 150 (120,180) 150 (120,180) .81
Blood loss, median (IQR), mL 100 (100,200) 100 (50,200) 100 (100,150) .83
Stoma formation, n (%) 20 (31) 11 (32) 9 (29) .77
Hemoglobin, mean ± SD, g/dL 12 ± 2.6 12 ± 3.0 12 ± 2.0 .92
Albumin, mean ± SD, g/dL 2.75 ± 0.6 2.8 ± 0.6 2.7 ± 0.7 .32
Site of perforation, n (%)
Peptic ulcer perforation 29(44.6) 17(50) 12(38.7) .46
Small bowel perforation 29(44.6) 15(44.1) 14(45.2)
Colonic perforation 5(7.7) 1(2.9) 4(12.9)
Appendicular perforation 2(3.1) 1(2.9) 1(3.2)

BMI, body mass index; NPWT, negative pressure wound therapy.

Table II
Postoperative outcomes of 2 allocation groups

Total (65) NPWT group (34) Standard care group (31) Odds ratio, 95% CI P value

Incisional SSI, n (%) 25 (38.5) 6 (17.6) 19 (61.3) 7.38 (2.36:23.1) < .01
Superficial SSI 11(16.9) 3(8.8) 8(25.8)
Deep SSI 14(21.5) 3(8.8) 11(35.5)
Fascial dehiscence, n (%) 18 (27) 3 (9) 15 (48) 9.68 (2.44:38.45) < .01
Delayed primary closure, n (%) 46 (71) 31 (91) 15 (48) .09 (0.02:0.36) < .05
Complete wound healing duration, d, median (IQR) 20 (18,37) 19(17,22) 26 (19,120) < .01
Postoperative hospital stays, d, median (IQR) 9 (7,14) 9 (7,12) 10 (7,15) .28
Mortality (30 d), n (%) 5 (8) 2 (6) 3 (9.7) 0.58 (0.09:3.74) .66

NPWT, negative pressure wound therapy; SSI, surgical wound infection.

was significantly lower in the NPWT group compared to the no angiogenesis and extracellular matrix deposition and improves
standard care group (19 days vs 26 days, P < .01). The median granulation.14 Therefore, patients will likely benefit from NPWT in
postoperative stay was not significantly different between the dirty wounds.
groups (9 days in the NPWT group vs 10 days in the standard care The complications associated with incisional wound infections
group; P ¼ .28). The 30-day mortality was not significantly different are delayed healing, prolonged hospital stay, wound dehiscence,
between the 2 groups (2 in the NPWT group vs 3 in the standard sepsis, incisional hernia, and disfiguring scars. In our study, com-
care group; P ¼ .66). None of the patients required reapplication of plete wound healing time and wound dehiscence were significantly
NPWT, and no adverse event was reported in the NPWT group. In a lower in NPWT groups. A significant number of wound healings
subgroup analysis of stoma patients, the use of NPWT is associated occurred by secondary intention in the standard care group (52% vs
with significantly less risk of SSI (4 [30.7%] vs 9 [69.3%]; P ¼ .03). 9%). These complications have a significant impact on the physical
and psychological health of patients.15e17 The use of NPWT in
Discussion preventing SSI in clean and clean-contaminated wounds is well
studied and shows promising results.7,18 The use of NPWT in the
In this single-center randomized controlled trial, we found that high-risk wounds of pancreaticoduodenectomy patients showed a
the use of NPWT on the surgical incision in patients with GIP significant decrease in the risk of surgical site infection in ran-
significantly reduced the rate of SSI and wound dehiscence. The domized controlled trials.19 Studies on NPWT in dirty abdominal
overall incidence of SSI in the present study was 38.5%. The use of wounds are few.10,11,20 A study by Danno et al10 compared NPWT
NPWT also significantly increased the rate of delayed primary and delayed wound closure with primary wound closure in patients
wound closure and improved wound healing time. with dirty wounds of lower gastrointestinal perforation. The use of
It has been hypothesized that epithelization of the primarily NPWT showed a significantly reduced risk of incisional SSI
closed wounds occurs within 24 to 48 hours. In the presence of compared to primary wound closure. (10.7% vs 63.2%). However, in
bacterial contamination, as would happen in the setting of GIP, this study, the control arm of primary closure was historical control.
these wounds serve as the best medium for bacterial growth. There are few reports on the use of NPWT after the primary
Applying negative pressure would prevent the stagnation of dirty, closure of surgical wounds with equivocal results. However, most
contaminated fluid and exudate at the local site, which is an reports are based on elective abdominal surgery of clean or clean-
important factor in the proliferation of bacteria. The negative contaminated wounds.20,21 In our study, all wounds were grossly
pressure also improves local perfusion at the local wound site, thus contaminated, and we believe that applying NPWT in closed
improving wound healing.13 Creating a hypoxic environment by wounds in this setting is inappropriate. Delayed primary closure
negative pressure dressing upregulates inflammatory cytokines was reported as a standard practice before this study was planned.
and growth factor expression. This results in the stimulation of In previous randomized studies, DPC showed a significant decrease
 H. Singh et al. / Surgery 174 (2023) 291e295 295

in SSI compared to primary wound closure.4,22 In our study, a sig- Supplementary materials
nificant proportion of patients in the standard care group could not
achieve DPC and developed SSI (52% vs 9%). The use of NPWT helps Supplementary materials associated with this article can be
make these wounds more suitable for early closure and signifi- found in the online version 10.1016/[Link].2023.04.018.
cantly decreases SSI.
Similar to other studies,11,23 one important risk factor identified References
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