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NCT06725459NARecruiting

NPWT Reduction Mammaplasty

Medstar Health Research Institute

Start Date

12/17/2024

Completion Date

11/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DEVICE

Prophylactic ciNPWT

OTHER

Standard Adhesive Dressing

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Conditions

HealthyMacromastiaNegative Pressure TherapyMammaplastyWound Healing

Locations

Medstar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States