NPWT Reduction Mammaplasty

Description

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

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Study Overview

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Study Details

Study overview

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.

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

NPWT Reduction Mammaplasty

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Washington

Medstar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medstar Health Research Institute,

Kenneth L Fan, MD, PRINCIPAL_INVESTIGATOR, MedStar Georgetown University Hospital

Study Record Dates

2025-11-01