Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06725459

NPWT Reduction Mammaplasty

Led by Medstar Health Research Institute · Updated on 2025-10-27

92

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

Sponsors

M

Medstar Health Research Institute

Lead Sponsor

3

3M

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

NPWT Reduction Mammaplasty

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Medstar Georgetown University Hospital

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

Actively Recruiting

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Research Team

R

Ryan P Lin, MD

CONTACT

K

Kenneth L Fan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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