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

January 2, 2026 updated by: Abdallah Ali Abdallah Hussein, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Linear Closure Arm
Patients undergo stoma reversal surgery with skin wound closed using conventional linear technique: simple interrupted Prolene sutures after standard internal layer closure. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up.
Procedure: Conventional linear skin closure
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.
Active Comparator: Purse-String Closure Arm
Patients undergo stoma reversal surgery with skin wound closed using purse-string technique: internal layers closed standardly, subcutaneous layer with Vicryl purse-string, skin with Prolene purse-string. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up.
Procedure: Purse-string skin closure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Minimum 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • wound closure in children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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