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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2027
  • participants needed
    78
  • sponsor
    University of California, San Francisco
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Updated on 28 August 2025
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Summary

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.

Description

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.

Details
Condition Acne
Age 19years or above
Clinical Study IdentifierNCT07147166
SponsorUniversity of California, San Francisco
Last Modified on28 August 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥ 19
Undergoing double incision gender affirming mastectomy
Ability to adhere to Brijjit therapy after surgery
Willing to return for follow-up visits and undergo study evaluations

Exclusion Criteria

History of keloid formation
Radiation therapy history
Prior surgeries of the chest or breast
History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
Active smoker
Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
Any other condition determined by PI to preclude subject from joining study
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