Actively Recruiting
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
Led by University of California, San Francisco · Updated on 2026-01-22
78
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Undergoing double incision gender-affirming mastectomy
- Able to adhere to Brijjit therapy after surgery
- Willing to return for follow-up visits and undergo study evaluations
You will not qualify if you...
- History of keloid formation
- History of radiation therapy
- Prior chest or breast surgeries
- Use of Accutane within the past year
- Use of chronic systemic steroids
- Active smoker
- Disorders negatively affecting wound healing (autoimmune, connective tissue disease, uncontrolled diabetes)
- Any other condition deemed by the principal investigator to prevent study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, United States, 94131
Actively Recruiting
Research Team
L
Lindsay A Tao, BS
CONTACT
C
Carolyn Cafro, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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