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

Recruiting now · Not applicable

Conditions studied: Gender Dysphoria, Mastectomy, Hypertrophic Scar

In brief

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.

Key facts

Study ID

NCT07147166

Run by

University of California, San Francisco

People needed

78

Starts

2025-02-03

Expected to finish

2032-06-01

Last updated by the study team

2026-06-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Department of Plastic & Reconstructive Surgery — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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