Compare Stoma Reversal Wound Outcomes Between NPWT and Secondary Intention Healing (NCT07258134) | Clinical Trial Compass
CompletedNot Applicable
Compare Stoma Reversal Wound Outcomes Between NPWT and Secondary Intention Healing
Pakistan72 participantsStarted 2025-02-24
Plain-language summary
This was a single-center, parallel-group randomized controlled trial conducted in 2024 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Highest Postoperative Asepsis Score for SSI assessment
Timeframe: Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)
Trial details
NCT IDNCT07258134
SponsorSindh Institute of Urology and Transplantation