Background: Perforation peritonitis is a serious surgical emergency due to heavy intra-abdominal contamination and a high incidence of postoperative surgical site infections (SSIs). Conventional primary closure of such contaminated laparotomy wounds often entraps bacteria, resulting in wound disruption.
Objectives: To compare clinical efficacy of NPWT with delayed wound closure and primary wound closure on SSI rates and healing in patients undergoing surgery for perforation peritonitis.
Material and Methods: A prospective randomized controlled trial was performed on 60 patients (30 in each arm) who developed perforation peritonitis and presented for emergency laparotomy. After source control, the NPWT cohort were managed with continuous sub-atmospheric pressure (-125 mmHg) for three days followed by standard dressings, and the control cohort underwent immediate primary closure. Primary end points were SSI incidence, epithelialization time, and infection relative risk.
Results: The baseline demographic and operative parameters were similar between groups. NPWT group had a significantly lower rate of surgical site infection (SSI) than conventional primary closure group (13.3% vs 43.3%, p = 0.010). In addition, NPWT effectively obstructed superficial SSIs and promoted rapid epithelialization (p = 0.019). The relative risk of developing an SSI in the NPWT cohort was 0.308 (95% CI: 0.113–0.836, p = 0.022) indicating a decrease of 69% in the probability to experience an infection.
Conclusion: NPWT with delayed closure was found to be a very effective, safe alternative of Primary Closure in Perforation peritonitis. It greatly reduces SSI risk and improves tissue healing without increasing the rate of other wound complications.
Perforation peritonitis has, unfortunately, remained a major and common surgical emergency most often due to hollow viscus perforation leading to massive gastrointestinal spillage in the peritoneal cavity. Despite modern advances in critical care and effective antimicrobial therapy, this condition is associated with significant morbidity that is particularly influenced by postoperative wound complications.1 Emergency laparotomy incisions in these circumstances are inherently categorized as contaminated or dirty, placing the surgical site at risk for high bacterial inoculums and severe systemic inflammatory responses. As a result, surgical site infections (SSIs) occur in 30% to 60% of these patients and cause delayed healing, fascial dehiscence, and prolonged hospital stays.2
The conventional standard of care entails closure of the wound primarily after the laparotomy; however, sealing a contaminated surgical field inevitably locks in place necrotic debris and bacterial organisms within a hypoxic environment that actively favours ongoing microbial growth and purulent exudate generation.3 In order to overcome these negative physiological conditions, Negative Pressure Wound Therapy (NPWT) or vacuum-assisted closure, has evolved as a dynamic wound modulation therapy. NPWT continuously evacuated infected exudates by control of sub-atmospheric pressure, decreased interstitial oedema, and mechanically stimulated local microcirculation to form robust granulation tissue.4 Although the use of prophylactic NPWT has demonstrated benefits in clean-contaminated surgeries, its effects on perforation peritonitis highly septic environment have not been specifically assayed. This study is a randomized controlled trial designed to determine whether NPWT followed by delayed closure provides improved wound healing and reduced relative risk for SSI compared to conventional primary closure in a tertiary care setting.
MATERIALS AND METHODS
Study Design and Setting:
This prospective randomized controlled trial was carried out over a period of one year at the Department of Surgery, M.G.M. Medical College and M.Y. Hospital, Indore, a high-volume tertiary care teaching institution. The study followed the institutional ethical guidelines and was approved formally.
Study Population:
Sample size calculation was based upon the expected differences in event proportions between the two study arms, using the following formula for comparing two independent proportions: n= (Zα+Z β)2 (P1Q1 + P2Q2)/(P1-P2)2, where Q1=100-P1 and Q2=100-P2, at a 90% statistical power (Zβ = 1.28) at a 95% confidence level (Zα = 1.96), projecting outcomes to be 13.7% (P1) in the NPWT cohort and 50.0% (P2) in the conventional cohort, where Q1=100-P1 and Q2=100-P2. Based on this statistical calculation, a minimum of 29.34 subjects per arm were necessary and thus 30 patients for each cohort were deemed adequate resulting in an overall sample size of 60 subjects.
Thus, the trial randomized 60 adult patients (>18 years old) admitted for emergency abdominal surgery with closed laparotomy wounds. Exclusion criteria included allergies to NPWT dressing materials, history of abdominal surgeries at any site, pre-existing surgical site infection and refusal for informed consent. Eligible patients were prospectively randomized into two equal cohorts of 30 patients each: Group A (NPWT + delayed wound closure) and Group B (Conventional primary wound closure).
Surgical Procedure and Intervention:
All participants had a standard exploratory laparotomy. After adequate intra-abdominal source control and peritoneal lavage, the fascial layer (rectus sheath) was approximated.
Operational Definitions and Follow-up
Patients were closely followed up on postoperative day 14, 21, and 30 endpoints such as presence of surgical site infection (SSI), epithelialization time, wound dehiscence seroma formation and cosmetic scores. Data were entered in Microsoft Excel and statistically analysed through JAMOVI statistical software. Continuous data were presented as mean ± standard deviation or median with interquartile range. Categorical variables were reported as frequencies and percentages. Chi-square test or Fisher’s exact test were used to compare the two study groups for categorical variables. P values less than 0.05 were considered statistically significant.
Figure 1: Wound after application of Negative Pressure Dressing
Figure 2: Showing wound immediately after removing the NPWT dressing at post-operative day 3
RESULTS
The baseline socio-demographic and clinical characteristics of the 60 study participants are illustrated in Table 1. There were no statistically significant variations in mean age, gender demographic, or systemic comorbidities between the Negative Pressure Wound Therapy (NPWT) and traditional primary closure cohorts. Moreover, perforation aetiology and intraoperative peritoneal contamination degree showed a similar distribution within both groups; thus preventing pre-existing physiological and anatomical factors from confounding the post-operative healing outcomes.
Table 2 describes the preoperative laboratory parameters and the mean times of surgical procedures. Despite comparable haemoglobin concentrations, serum albumin levels and total operative times between the two study arms, more patients in the NPWT cohort had significantly higher baseline white blood cell (WBC) counts (p = 0.048). This increased leucocytosis suggests a significantly greater baseline systemic inflammatory and infectious load in the intervention group before source control was achieved surgically.
The incidence and anatomic depth of SSIs in surgeries performed by individual groups are summarized in Table 3 and Figure 3. NPWT resulted in a significant reduction in overall SSI rates (13.3% v 43.3% for the conventional primary closure group) (p = 0.010). Essentially, the NPWT protocol virtually eliminated superficial incisional infections and modulated deep fascial infection spread, signifying an enormous significance in preventing tissue injury at the incision microenvironment level.
The relative risk (RR) analysis for the development of postoperative wound infections is shown in Table 4 and in Figure 4. Statistical analysis yielded an RR of 0.308 (95% CI: 0.113–0.836); p = 0.022. The strong evidence while using this quantitative measure is that sub-atmospheric pressure therapy followed by delayed fascial approximation achieved a remarkable 69% relative reduction in infection risk compared to immediate primary wound closure.
Table 5 illustrates differences in the postoperative healing dynamics, showcasing the time needed for full epithelialization between treatment cohorts. Our study shows that patients treated under the NPWT protocol exhibited a significant increase in epithelialization scores compared to those managed by traditional methods (p = 0.019), indicating that NPWT is more effective and result-getting than conventional management. In light of these data, the perpetuation of a stable wound bed may suggest that controlled negative pressure directly promotes stabilization of any exuding factors that deter cellular proliferation necessary for optimal epidermal repair.
Table 1: Baseline Socio-demographic and Clinical Characteristics
|
Parameter |
NPWT Cohort (n = 30) |
Conventional Cohort (n = 30) |
p-value |
|
Age (years), Mean ± SD |
52.87 ± 15.43 |
46.30 ± 18.36 |
0.139 |
|
Sex, n (%) |
|
|
|
|
Male |
17 (58.6%) |
12 (41.4%) |
0.196 |
|
Female |
13 (41.9%) |
18 (58.1%) |
|
|
Primary Diagnosis, n (%) |
|
|
|
|
Peptic Perforation |
8 (47.1%) |
9 (52.9%) |
0.985 |
|
Ileal Perforation |
9 (50.0%) |
9 (50.0%) |
|
|
Appendicular Perforation |
7 (50.0%) |
7 (50.0%) |
|
|
Others |
6 (54.5%) |
5 (45.5%) |
|
|
Comorbidities Present, n (%) |
18 (58.1%) |
13 (41.9%) |
0.196 |
|
Contamination Grade, n (%) |
|
|
|
|
Mild |
5 (33.3%) |
10 (66.7%) |
0.286 |
|
Moderate |
12 (60.0%) |
8 (40.0%) |
|
|
Severe |
13 (52.0%) |
12 (48.0%) |
Table 2: Preoperative Laboratory Parameters and Operative Duration
|
Parameter |
NPWT Cohort (Mean ± SD) |
Conventional Cohort (Mean ± SD) |
p-value |
|
Hemoglobin (g/dL) |
11.44 ± 1.67 |
11.72 ± 1.52 |
0.506 |
|
Albumin (g/dL) |
3.66 ± 0.42 |
3.81 ± 0.41 |
0.179 |
|
WBC Count (cells/mm³) |
11,991.47 ± 2,664.67 |
10,611.17 ± 2,627.19 |
0.048 |
|
Operative Time (min) |
118.23 ± 25.16 |
113.03 ± 25.67 |
0.431 |
Table 3: Incidence and Typology of Surgical Site Infection (SSI)
|
SSI Classification |
NPWT Cohort (n = 30) |
Conventional Cohort (n = 30) |
p-value |
|
Overall SSI Incidence, n (%) |
4 (13.3%) |
13 (43.3%) |
0.010 |
|
SSI Typology |
|
|
|
|
No Infection |
26 (86.7%) |
17 (56.7%) |
0.013 |
|
Superficial SSI |
0 (0.0%) |
6 (20.0%) |
|
|
Deep SSI |
4 (13.3%) |
7 (23.3%) |
Figure 3: Incidence and Depth of Surgical Site Infection by Treatment Group
Table 4: Relative Risk Analysis for Surgical Site Infection
|
Measure |
Value |
|
Risk in NPWT Cohort |
0.133 (13.3%) |
|
Risk in Conventional Cohort |
0.433 (43.3%) |
|
Relative Risk (RR) |
0.308 |
|
95% Confidence Interval |
0.113 – 0.836 |
|
p-value |
0.022 |
Figure 4: Forest Plot of Relative Risk for Surgical Site Infection
Table 5: Time to Complete Epithelialization
|
Group |
Mean ± SD (Days/Score) |
p-value |
|
NPWT Cohort |
0.93 ± 0.254 |
0.019 |
|
Conventional Cohort |
0.70 ± 0.466 |
|
NPWT with delayed primary closure is a very effective, safe and biologically superior alternative in perforation peritonitis compared to immediate primary closure. It significantly decreases both the incidence and severity of surgical site infections, actively promotes epithelialization, and markedly lowers relative risk of infection without increasing seroma or dehiscence rates; thus supporting its adoption in emergency surgical protocols.
Recommendations
Surgical units treating high-risk, contaminated laparotomies in a healthcare setting concern NPWT and delay closure protocols as a routine modality to reduce the burden of severe wound morbidity and unify management on infection control.
Strengths and Limitations
The rigorous randomized controlled underpinning affords significant internal validity, but the somewhat limited cohort (n=60 people) from a single tertiary institution may limit wider epidemiological extrapolation.
Relevance of the Study
Provides vital, actionable clinical evidence for customizing wound survivability optimization in mega-lethal emergency general surgery presentations.
Authors’ Contribution
Conceptualization, data collection, statistical analysis and manuscript preparation were conducted by all authors equally.
Ethical Consideration
Institutional Ethics Committee approval; written informed consent was strictly obtained from all participants before enrolment.
Financial Support and Sponsorship
Nil.
Conflicts of Interest
None.
CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP. Centers for disease control and
prevention guideline for the prevention of surgical site infection, 2017. JAMA surgery.
2017 Aug 1;152(8):784-91.
applications of the vacuum-assisted closure (VAC) device: a review. American journal
of clinical dermatology. 2005 Jun;6(3):185-94.
Ginzburg E, Augenstein JS, Byers PM, Sands LR. Prospective randomized trial of two
wound management strategies for dirty abdominal wounds. ANNALS of Surgery. 2001
Mar 1;233(3):409-13.