Status:
RECRUITING
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
Lead Sponsor:
University of California, San Francisco
Conditions:
Gender Dysphoria
Mastectomy
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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...
Detailed 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 compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07147166
Start Date
September 20 2025
End Date
June 1 2027
Last Update
August 28 2025
Active Locations (1)
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1
UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, United States, 94131