NPWT Reduction Mammaplasty

MedStar Health

Status: Enrolling

Conditions: Healthy; Mammaplasty; Wound Healing; Negative Pressure Therapy; Macromastia

Treatments: Device: Prophylactic ciNPWT; Other: Standard Adhesive Dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06725459

STUDY00007266

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Prophylactic ciNPWT

Experimental group

Description:

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.

Treatment:

Device: Prophylactic ciNPWT

Standard Adhesive Dressing

Active Comparator group

Description:

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.

Treatment:

Other: Standard Adhesive Dressing