Comparing wound healing methods in breast reduction surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of prophylactic closed incision negative pressure wound therapy (ciNPWT) compared to standard adhesive dressing in female patients undergoing bilateral reduction mammaplasty. It is a prospective, randomized, split-body control trial that will assess complications, patient-reported outcomes, and cost differentials associated with each method. Participants will be monitored for their recovery and satisfaction following the surgical procedure. The study is being conducted at MedStar Georgetown University Hospital and MedStar Good Samaritan Hospital.

Why it matters

Who can join: the full rules

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)

Where it's running

• Medstar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Kenneth L Fan, MD — MedStar Georgetown University Hospital
• Study coordinator: Ryan P Lin, MD
• Email: Ryan.Lin@medstar.net
• Phone: 2407787804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.