Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial

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 outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing. Should our hypotheses be proven, this study will provide a compelling reason to implement Brijjit therapy into standard clinical practice as a non-invasive preventative measure to improve scar outcomes.

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 condition determined by PI to preclude subject from joining study