NPWT Reduction Mammaplasty

NCT06725459 | Recruiting FDA Device

• 1 other identifier: STUDY00007266
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mammaplasty; macromastia; breast reduction; negative pressure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient-Reported Pain (VAS)

  Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively

• Scar Quality (POSAS)

  1 month and 3 months postoperatively

• Patient Satisfaction with Breasts (BREAST-Q)

  Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively

• Cost Differential: Dressing-Related Costs

  Through study completion, an average of 6 months

• Cost Differential: Healthcare Resource Use

  Through study completion, an average of 6 months

Study Arms (2)

Prophylactic ciNPWT

EXPERIMENTAL

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

Standard Adhesive Dressing

ACTIVE COMPARATOR

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

Interventions

Prophylactic ciNPWT DEVICE

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.

Prophylactic ciNPWT

Standard Adhesive Dressing OTHER

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.

Standard Adhesive Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• 3M: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Kenneth L Fan, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan P Lin, MD

CONTACT

2407787804; Ryan.Lin@medstar.net

Kenneth L Fan, MD

CONTACT

(202) 444-8751; kenneth.l.fan@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 10, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)