Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT06725459
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06725459
Study Brief:
Protocol Section:
NCT06725459