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New wound dressing could speed healing after breast reduction

NCT ID NCT06725459

Symptom relief Sponsor: Medstar Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a closed incision negative pressure wound therapy (ciNPWT) device can reduce wound complications after breast reduction surgery. 92 women will have one breast treated with the device and the other with standard adhesive strips. The goal is to see if the device leads to fewer infections, less pain, and better scar quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Closed incision negative pressure wound therapy (ciNPWT) device
What this could lead to
If it works, this could mean fewer wound problems and better healing after breast reduction surgery.
What could go wrong
This is a small, early-stage trial with only 92 participants, so results may not apply to everyone. The device is used for just 7 days, and long-term benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

familial juvenile hypertrophy of the breast hypertrophy of breast injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Macromastia Mammaplasty Negative pressure therapy Wound healing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medstar Georgetown University Hospital

    RECRUITING

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.