University of California, San Francisco
The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
The hypothesis of this study is that the use of Brijjit® Force-Modulating Tissue Bridge devices will reduce the incidence of hypertrophic scarring as measured by objective and subjective factors compared to no intervention following gender-affirming double incision mastectomy. Patients will serve as self-controls (one side of the chest will receive the intervention, the other will not). Consistent use of silicone-based tape, the current gold standard for wound care, will be encouraged on the control side of the chest. We hypothesize that applying FMTBs to surgical incisions will improve scar…
Inclusion Criteria: 1. Age ≥ 19 2. Undergoing double incision gender affirming mastectomy 3. Ability to adhere to Brijjit therapy after surgery 4. Willing to return for follow-up visits and undergo study evaluations Exclusion Criteria: 1. History of keloid formation 2. Radiation therapy history 3. Prior surgeries of the chest or breast 4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids 5. Active smoker 6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes) 7. Any other cond…
Brijjit® BP-100 and BP-75 are a non-invasive, flexible devices that acts as a force modulating tissue bridge (FMTB) to aid in wound healing. BP-100 and BP-75 simply refer to different sizes of the Brijjit device.
The control chest side will receive only standard of care and normal wound dressing.
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