Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial
University of California, San Francisco
78 participants
Feb 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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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Interventions
Brijjit® BP-100 and BP-75 are a non-invasive, flexible devices that acts as a force modulating tissue bridge (FMTB) to aid in wound healing. BP-100 and BP-75 simply refer to different sizes of the Brijjit device.
The control chest side will receive only standard of care and normal wound dressing.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07147166