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

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.

NCT Number	NCT07147166
Lead Sponsor	University of California, San Francisco
Conditions	Gender Dysphoria, Mastectomy, Hypertrophic Scar
Enrollment	78 participants
Start Date	2025-02-03
Primary Completion	2032-06-01 (estimated)
Study Completion	2032-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-04