Prophylactic Use of ciNPWT in Gynecologic Laparotomy (NCT07645547) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prophylactic Use of ciNPWT in Gynecologic Laparotomy
30 participantsStarted 2026-07
Plain-language summary
This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing.
Participants will:
* Get ciNPWT or standard dressing after planned laparotomy
* Answer the questionairs about qualite of life
* Will visit the clinic 30 days after surgery to see the final result
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Adult female patients scheduled for planned abdominal surgery for gynecologic or gynecologic-oncologic indications.
Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.
Signed informed consent.
Exclusion Criteria:
* Failure to provide informed consent.
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.
1This trial is testing whether a special wound dressing that uses gentle suction — called closed incision negative pressure wound therapy, or ciNPWT — is practical to use after gynecologic abdominal surgery to help prevent infections and wound problems; could you explain how this device works and whether my type of surgery would be relevant to what the trial is studying?
2Since this trial hasn't started recruiting yet and is in a feasibility phase rather than a full effectiveness trial, what does that mean for how much is already known about whether this wound dressing actually reduces my risk of infections, seromas, or wound separation compared to a standard dressing?
3The trial is focused on preventing surgical site complications like infection, hematoma, and wound breakdown after gynecologic laparotomy — are any of these complications a realistic concern for my specific procedure, and is this trial something worth revisiting once it opens to enrollment?
4Because this study is measuring feasibility — meaning it's largely figuring out whether the approach is practical to run — rather than directly proving the wound device works better, how would I weigh participating in a feasibility study against simply receiving whatever wound care your team currently recommends as standard practice?
5Given that the trial isn't recruiting yet, are there similar studies already completed or currently open that are looking at ciNPWT for wound complication prevention after abdominal gynecologic surgery that we could look into now?
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.