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

What this Trial Is About

Researchers are evaluating the use of Brijjit4 Force-Modulating Tissue Bridge devices to reduce the occurrence of hypertrophic scars in individuals undergoing gender-affirming bilateral double incision mastectomies. This randomized, self-controlled trial compares one side of the chest treated with Brijjit4 to the other side receiving standard wound care, aiming to improve scar appearance and quality. The study also assesses patient perceptions of their scars using the Patient and Observer Scar Assessment Scale (POSAS). Participants will have Brijjit4 applied during surgery across the entire incision length on one chest side, randomly assigned. The device typically lasts 2-4 weeks and will be replaced if it falls off before 6 weeks post-operation, with patients taught how to reapply it at home. The treated side receives this intervention until 6 weeks post-op, while the control side receives standard wound dressing and care. After 6 weeks, all Brijjit4 devices are removed, and participants can begin recommended scar care on both sides. During the study, participants will attend follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operation for scar assessments. Researchers will evaluate scar presence, characteristics, and dimensions at these intervals, along with patient-reported scar perception. The study involves monitoring scar development and wound healing progress over time to understand the effects of Brijjit4 compared to standard care.

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