WithdrawnNot Applicable

NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

Stopped: Study details changed, new Trial Registration process begun for modified protocol

Canada0Started 2023-09

Plain-language summary

The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

Who can participate

Age range

18 Years – 70 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: * Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy * Patients going either unilateral or bilateral reconstruction Exclusion Criteria: * Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. - * Patients who have contraindications to the ciNPT * Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study. * Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.

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

Postoperative Surgical Site Infection (SSI)

Timeframe: 30 days after operation

Trial details

NCT IDNCT05338281

SponsorWestern University, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

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