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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Purse-string skin closure
Procedure/SurgeryDuring 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/SurgeryDuring 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Locations
Sponsors and contacts
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