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NCT Number: NCT06725459

NPWT 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.

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Key information

Conditions

Healthy Gigantomastia Macromastia Mammaplasty Negative Pressure Therapy Wound Healing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medstar Georgetown University Hospital

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Postoperative Wound Complications

    Time frame: 30 days postoperatively

    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).

Secondary outcomes

  1. Patient-Reported Pain (VAS)

    Time frame: Immediate postoperative period, 1 week postoperatively, and 3 months postoperatively

    Patient-reported pain will be assessed using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (maximal imaginable pain).

  2. Scar Quality (POSAS)

    Time frame: 1 month and 3 months postoperatively

    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).

  3. Patient Satisfaction with Breasts (BREAST-Q)

    Time frame: Preoperative baseline, 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, and 6 months postoperatively

    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.

  4. Cost Differential: Dressing-Related Costs

    Time frame: Through study completion, an average of 6 months

    Costs associated with dressings will include the unit price of ciNPWT and standard adhesive dressings and healthcare professional time for application and removal.

  5. Cost Differential: Healthcare Resource Use

    Time frame: Through study completion, an average of 6 months

    Healthcare resource use will include hospital stay durations, additional procedures for managing complications, and any unplanned follow-up visits.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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