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Completed
NCT07258134
Compare Stoma Reversal Wound Outcomes Between NPWT and Secondary Intention Healing
Conditions: Negative-Pressure Wound Therapy, Wound Heal, Stoma Site Infection, Surgical Site Infection
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Maryam Arbab
Location: Sindh Institute of Urology and Transplantation Karachi Sindh
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.
Eligibility Criteria
Inclusion Criteria:
All patients aged between 18-80 years undergoing stoma reversal surgery were included, following their formal consent for inclusion in the study protocol.
Exclusion Criteria:
* Patients with history of prolonged antibiotic use prior to stoma reversal surgery (\>1months).
* Patients with prior skin condition that required medical treatment (for instance, Plaque Psoriasis).
* Patient with prior history of wound-related complication (like keloids or hypertrophic scars).
Furthermore, after allocation, the patients with the following protocol violations were also excluded:
* Patients who had undergone any other forms of wound closure after stoma reversal, that deviated from the study protocol.
* Patients who were re-operated during the hospital stay for any other reason than surgical site infection.
Source: ClinicalTrials.gov (NCT07258134). StuddyBuddy aggregates publicly available trial information.