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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07147166
Status
Recruiting
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Conditions

  • Gender Dysphoria
  • Hypertrophic Scar
  • Mastectomy

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Brijjit® BP100-6 and BP-75 — DEVICE
    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.
  • Control: Standard of care and normal wound dressing — OTHER
    The control chest side will receive only standard of care and normal wound dressing.

Study Details

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 Dates

Start date
Feb 3, 2025
Status verified
Jun 2026
Primary completion
Jun 1, 2032
Completion
Jun 1, 2032

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Self-control Brijjit Application and Control
    The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides. The control chest side will receive only standard of care and normal wound dressing.

Primary Outcome Measure

Presence of Hypertrophic Scarring [ Time Frame: 6 weeks postop ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Department of Plastic & Reconstructive SurgerySan FranciscoCalifornia94131
Esther A Kim, MD
[email protected]
(415) 353-4201

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UCSF Department of Plastic & Reconstructive Surgery· San Francisco, CA

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