NPWT Reduction Mammaplasty

Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Wound Healing; Mammaplasty; Macromastia; Negative Pressure Therapy
• Intervention / Treatment: Device: Prophylactic ciNPWT; Other: Standard Adhesive Dressing

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth L Fan, MD; Phone Number: 1 (202) 444-8751; Email: kenneth.l.fan@medstar.net
• Study Contact Backup: Name: Ryan P Lin, MD; Phone Number: 1 2407787804; Email: Ryan.Lin@medstar.net

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Principal Investigator: Kenneth L Fan, MD
      • Contact: Kenneth L Fan, MD; Phone Number: 202-444-8751; Email: kenneth.l.fan@medstar.net
      • Contact: Ryan P Lin, MD; Phone Number: 1 2407787804; Email: Ryan.Lin@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic ciNPWT; 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.	Device: Prophylactic ciNPWT; 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.
Active Comparator: Standard Adhesive Dressing; 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.	Other: Standard Adhesive Dressing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Wound Complications	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).	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Pain (VAS)	Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain).	Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively
Scar Quality (POSAS)	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).	1 month and 3 months postoperatively
Patient Satisfaction with Breasts (BREAST-Q)	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.	Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively
Cost Differential: Dressing-Related Costs	Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal.	Through study completion, an average of 6 months
Cost Differential: Healthcare Resource Use	Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: 3M
• Investigators: Principal Investigator: Kenneth L Fan, MD, MedStar Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: mammaplasty; breast reduction; negative pressure therapy; macromastia
• Additional Relevant MeSH Terms: Gigantomastia
• Other Study ID Numbers: STUDY00007266

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes