Using negative pressure therapy to improve healing in obese patients after breast reconstruction surgery
A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04003038 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are unable to provide consent, pregnant, or have known allergies to topical adhesives may not benefit from this study.
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 performed: Previous studies have shown promising results with negative pressure wound therapy in various surgical settings, suggesting potential benefits in this context as well.
Eligibility criteria
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 this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Edward H Chang — M.D. Anderson Cancer Center
- Study coordinator: Edward H Chang
- Email: eichang@mdanderson.org
- Phone: 713-794-1247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.