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Official title NPWT Reduction Mammaplasty
ClinicalTrials.gov ID: NCT06725459
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Able to comply with study procedures and follow-up visits
You likely can't join if
- 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
See the full 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.