NPWT Reduction Mammaplasty
Purpose
In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.
Conditions
- Healthy
- Macromastia
- Negative Pressure Therapy
- Mammaplasty
- Wound Healing
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The Prevena Restor Bella Form™ wound vacuum will be applied to the reduction mammaplasty incision as directed for up to 7 days postoperatively. Prevena Restor Bella Form™ is a ciNPWT management system. ciNPWT management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prophylactic ciNPWT |
Participants in this arm will receive the prophylactic closed incision negative pressure wound therapy (ciNPWT) on one breast following reduction mammaplasty. The ciNPWT will be applied for up to 7 days postoperatively to promote wound healing and prevent complications. |
|
|
Active Comparator Standard Adhesive Dressing |
Participants in this arm will receive the standard adhesive strip dressing (Prineo Ethicon NJ) on the other breast following reduction mammaplasty. The standard dressing will be used as a control to compare postoperative outcomes against the ciNPWT. |
|
Recruiting Locations
Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute