Recruiting

NPWT Reduction

Sponsor:

Medstar Health Research Institute

Code:

NCT06725459

Conditions

Healthy

Macromastia

Negative Pressure Therapy

Mammaplasty

Wound Healing

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic ciNPWT

Standard Adhesive Dressing

Study Details

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

Study ID

NCT06725459

Start date

Dec 17, 2024

Status verified date

Oct, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Incidence of Postoperative Wound Complications [ Time Frame: 30 days postoperatively ]

Central Contacts and Locations

Central contacts

Ryan P Lin, MD

2407787804Ryan.Lin@medstar.net

Kenneth L Fan, MD

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

Locations

Medstar Georgetown University Hospital

Recruiting

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

Contacts

Kenneth L Fan, MD

202-444-8751kenneth.l.fan@medstar.net

Ryan P Lin, MD

2407787804Ryan.Lin@medstar.net

Principal Investigator:

Kenneth L Fan, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

  • mammaplasty
  • macromastia
  • breast reduction
  • negative pressure therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-10-27.