Comparing wound healing methods in breast reduction surgery
Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
This study is testing if a special type of wound treatment helps women heal better after breast reduction surgery compared to regular bandages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06725459 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of prophylactic closed incision negative pressure wound therapy (ciNPWT) compared to standard adhesive dressing in female patients undergoing bilateral reduction mammaplasty. It is a prospective, randomized, split-body control trial that will assess complications, patient-reported outcomes, and cost differentials associated with each method. Participants will be monitored for their recovery and satisfaction following the surgical procedure. The study is being conducted at MedStar Georgetown University Hospital and MedStar Good Samaritan Hospital.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 years or older scheduled for bilateral reduction mammaplasty with specific incision patterns.
Not a fit: Patients who are biologically male, younger than 18, or have a history of breast cancer or other significant medical conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing breast reduction surgery.
How similar studies have performed: Other 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: * Female patients * Age 18 years or older * Scheduled to undergo bilateral reduction mammaplasty with a Wise pattern (anchor) incision and a superomedial, inferior, or central mound pedicle at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital * Able to comply with study procedures and follow-up visits Exclusion Criteria: * Younger than 18 years of age * Biologically male patients * Scheduled to undergo unilateral breast mammaplasty * Currently pregnant or lactating * Use of steroids or other immune modulators known to affect wound healing * Current smokers who have not paused for a minimum of 4 weeks prior to surgery * History of breast cancer * History of oncologic or reconstructive breast surgery * History of radiation to the breast * History of chemotherapy or hormone therapy * Tattoos in the area of skin incision * Skin conditions known to affect wound healing or scarring of the breast (e.g., cutis laxa) * Significant history of scar problems (e.g., hypertrophic scarring or keloids) post-surgical incisions with active bleeding * Exposure of blood vessels, organs, bone, or tendon at the base of the reference wound * Known allergies to product components (e.g., medical or NPWT tape) * Unable to comply with NPWT requirements, including those unable to present for postoperative follow-up * Lactating at the time of surgery * Require deviation from standard operative or closure techniques (e.g., staples, free nipple grafts) * Considered part of a vulnerable population (adults unable to consent, infants, children, teenagers, pregnant women, prisoners) * Experience intraoperative complications due to surgical complications not related to the NPWT instrumentation (e.g., expanding hematoma)
Where this trial is running
Washington D.C., District of Columbia
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth L Fan, MD — MedStar Georgetown University Hospital
- Study coordinator: Ryan P Lin, MD
- Email: Ryan.Lin@medstar.net
- Phone: 2407787804
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.