NPWT Reduction Mammaplasty

Not Applicable

Recruiting

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

• Registration Number: NCT06725459
• Lead Sponsor: Medstar Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-10
• Study Start: 2024-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-07-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Wound Complications	30 days postoperatively	The primary outcome measure is the incidence of postoperative wound complications within 30 days following reduction mammaplasty. This includes surgical wound dehiscence, delayed wound healing, and surgical site infections (SSIs).

Secondary Outcome Measures

Name	Time	Method
Scar Quality (POSAS)	1 month and 3 months postoperatively	Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) at 1 and 3 months postoperatively. The scale ranges from 6 (normal skin) to 60 (worst imaginable scar).
Patient-Reported Pain (VAS)	Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively	Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain).
Patient Satisfaction with Breasts (BREAST-Q)	Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively	Patient satisfaction with their breasts will be measured using the standardized BREAST-Q 2.0© questionnaire at the preoperative consultation, and at 1 week, 1 month, 3 months, and 6 months postoperatively.
Cost Differential: Healthcare Resource Use	Through study completion, an average of 6 months	Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits.
Cost Differential: Dressing-Related Costs	Through study completion, an average of 6 months	Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal.

Trial Locations

Locations (1)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States