Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal

This randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Fifty patients (25 per group) will be randomized at Assiut University Pediatric Surgery Department to determine if purse-string closure reduces infections and improves scarring.

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Key information

Conditions

Purse-String Suture Conventional Wound Closure Pediatric Surgery Stoma Reversal Procedure Wound Closure Technique

Age range

0 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Stoma reversal surgery is commonly performed in pediatric patients, but complications including surgical site infection (SSI), poor scarring, anastomotic leak, paralytic ileus, adhesive intestinal obstruction, bleeding, and incisional hernia remain concerns. The frequency of SSI and scar formation is directly related to the wound closure technique employed.

Skin wounds in stoma reversal are typically closed using conventional linear closure technique; however, this method carries a higher risk of surgical site infections. Studies in adults have demonstrated that purse-string wound closure technique achieves better cosmetic outcomes and reduced risk of SSI compared to conventional linear closure. However, high-quality data comparing these techniques in pediatric populations undergoing stoma reversal is lacking.

This randomized controlled trial will enroll 50 pediatric patients (aged 1 month to 18 years) undergoing stoma reversal at the Pediatric Surgery Department, Assiut University Hospitals. Participants will be randomized using a lottery method in a 1:1 ratio to receive either conventional linear closure (Group A) using simple interrupted Prolene sutures or purse-string closure (Group B) using Vicryl for subcutaneous layers and Prolene for skin in a purse-string technique.

All patients will undergo standard stoma reversal procedures and receive postoperative care per departmental protocols. Wounds will be evaluated after the first dressing change, at hospital discharge, during stitch removal, and at follow-up visits continuing for 3-4 months. Surgical site infection will be assessed using CDC criteria. Scar cosmesis will be evaluated at a minimum of 3 months post-surgery using the Manchester scar scale by three independent assessors.

The study aims to compare the frequency of surgical site infections and cosmetic outcomes between the two closure techniques, providing evidence-based guidance for optimal wound closure in pediatric stoma reversal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 1 month to 18 years undergoing stoma reversal after informed consent obtained from parents.

Exclusion criteria

Patients with divided stomas .
Patients who will lost to follow-up.
Patients who will develop anastomotic leakage, organ/space SSI.

Treatment and study plan

Purse-string skin closure

Procedure

During stoma reversal, internal layers closed standardly; subcutaneous tissue closed with continuous Vicryl purse-string suture, skin with Prolene purse-string suture. Distinguishes from linear closure by circular tightening technique to reduce SSI risk and improve cosmesis in pediatric patients.

Conventional linear skin closure

Procedure

During stoma reversal, skin wound closed with simple interrupted 3-0 Prolene sutures after standard internal and subcutaneous closure. Serves as active comparator to purse-string method; standard technique associated with higher SSI rates.

Primary outcomes

Surgical Site Infection (SSI)

Time frame: Up to 30 days post-surgery

Occurrence of SSI at stoma reversal site, defined per CDC criteria (purulent drainage, positive culture, or signs/symptoms of infection treated with antibiotics), assessed by surgeon at dressing changes, discharge, stitch removal, and patient-reported symptoms.

Secondary outcomes

Scar Cosmesis by Manchester Scar Scale

Time frame: Minimum 3 months post-surgery

Scar assessed using Manchester Scar Scale (vascularity, pigmentation, contour, texture; score 0-24, lower better) by average of three independent blinded assessors.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Outcomes of Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal : Ramdomized Controlled Trial(RCT).

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 13, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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