Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Using negative pressure therapy to improve healing in obese patients after breast reconstruction surgery

Official title: A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients

Run by M.D. Anderson Cancer Center · NCT04003038 · Data updated 2026-11-12

This study is testing if a special type of wound dressing can help obese patients heal better after breast reconstruction surgery compared to standard dressings.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment80 (estimated)
SponsorM.D. Anderson Cancer Center
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedMay 2, 2019
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedOctober 7, 2026
Trial IDNCT04003038 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are obese patients with a body mass index of 30 or greater who are scheduled for free abdominal flap breast reconstruction.

Probably not a fit

Patients who are unable to provide consent, pregnant, or have known allergies to topical adhesives may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of negative pressure wound therapy (NPWT) in enhancing the healing of abdominal incisions in obese patients undergoing free flap breast reconstruction surgery. Participants are randomly assigned to receive either standard dressing or NPWT for a duration of 7 days post-surgery. The primary objective is to assess the impact of NPWT on wound dehiscence rates, with follow-up evaluations conducted at 2 weeks, 1 month, and 3 months to monitor long-term wound healing complications.

Why it matters

Potential benefit: If successful, this approach could significantly improve wound healing outcomes for obese patients undergoing breast reconstruction.

How similar studies have gone: Previous studies have shown promising results with negative pressure wound therapy in various surgical settings, suggesting potential benefits in this context as well.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
* Patients are willing and able to give consent.
* Body mass index (BMI) greater than or equal to 30.0.

Exclusion Criteria:

* Patients who are unable to provide consent.
* Patients who are suspected or known to be pregnant.
* Known allergy to topical adhesives.

Where it's running

  • M D Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.