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COMPLETED
NCT07258134
NA

Compare Stoma Reversal Wound Outcomes Between NPWT and Secondary Intention Healing

Sponsor: Maryam Arbab

View on ClinicalTrials.gov

Summary

This was a single-center, parallel-group randomized controlled trial conducted in 2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. The study compared negative pressure wound therapy (NPWT) with healing by secondary intention (SIH) for patients undergoing stoma reversal surgery.

Official title: Negative Pressure Wound Therapy Versus Secondary Intention Healing in Stoma Reversal: A Randomized Controlled Trial Evaluating Surgical Site Infection and Wound Outcomes

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-02-24

Completion Date

2025-08-30

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

PROCEDURE

Negative Pressure Wound Therapy

In the NPWT (negative pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, NPWT dressing was reapplied. On postoperative day 6, final wound assessment was conducted and further management was carried out as per departmental protocol.

Locations (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, Pakistan