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 range18 Years – 70 Years

SexFEMALE

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.

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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