Clinical trial NCT06725459: NPWT Reduction Mammaplasty
Official title: Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Macromastia
Negative Pressure Therapy
Mammaplasty
Wound Healing
Keywords: mammaplasty
macromastia
breast reduction
negative pressure therapy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2024-12-10
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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: 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)

Primary outcomes:
measure: Incidence of Postoperative Wound Complications
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Patient-Reported Pain (VAS)
timeFrame: Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively
measure: Scar Quality (POSAS)
timeFrame: 1 month and 3 months postoperatively
measure: Patient Satisfaction with Breasts (BREAST-Q)
timeFrame: Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively
measure: Cost Differential: Dressing-Related Costs
timeFrame: Through study completion, an average of 6 months
measure: Cost Differential: Healthcare Resource Use
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Kenneth L Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: