NPWT Reduction Mammaplasty
Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
Medstar Health Research Institute
92 participants
Dec 17, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria20
- 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)
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Interventions
The prophylactic closed incision negative pressure wound therapy (ciNPWT) will be applied to one breast for up to 7 days postoperatively to promote wound healing and prevent complications.
The standard adhesive strip dressing will be applied to one breast immediately after surgery. It provides a protective covering for the wound during the initial healing phase and is the standard of care for incision management.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06725459