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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with divided stomas .

Patients who will lost to follow-up.

Patients who will develop anastomotic leakage, organ/space SSI.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Purse-string skin closure

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Conventional Linear Closure ArmExperimental treatment 1 intervention
Group B: Purse-String Closure ArmActive comparator 1 intervention

Trial outcomes

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.

Time frame
Up to 30 days post-surgery

Secondary outcomes

1

Scar Cosmesis by Manchester Scar Scale

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

Time frame
Minimum 3 months post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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