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

NCT07335835 | Not Yet Recruiting

• 1 other identifier: wound closure in children
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Purse-String Suture; Wound Closure Technique; Conventional Wound Closure; Stoma Reversal; Pediatric surgery

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (SSI)

  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 Outcomes (1)

• Scar Cosmesis by Manchester Scar Scale

  Minimum 3 months post-surgery

Study Arms (2)

Conventional Linear Closure Arm

EXPERIMENTAL

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

Purse-String Closure Arm

ACTIVE COMPARATOR

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

Interventions

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.

Purse-String Closure Arm

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.

Conventional Linear Closure Arm

Eligibility Criteria

• Age: 0 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Pediatric Surgery Department, Assiut University

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01