NCT07147166View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 20, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2027

Conditions
Gender DysphoriaMastectomyHypertrophic Scar
Interventions
DEVICE

Brijjit® BP100-6 and BP-75

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.

OTHER

Control: Standard of care and normal wound dressing

The control chest side will receive only standard of care and normal wound dressing.

Trial Locations (1)

94131

RECRUITING

UCSF Department of Plastic & Reconstructive Surgery, San Francisco

All Listed Sponsors
lead

University of California, San Francisco

OTHER