Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
Recruiting
N/A
Interventional Study
Gender Dysphoria
Mastectomy
Hypertrophic Scar
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 78 (estimated)
- Sponsor
- University of California, San Francisco · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 19
2. Undergoing double incision gender affirming mastectomy
3. Ability to adhere to Brijjit therapy after surgery
4. Willing to return for follow-up visits and undergo study evaluations
Exclusion Criteria:
1. History of keloid formation
2. Radiation therapy history
3…
Contacts