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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of California, San Francisco

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 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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Brijjit® BP100-6 and BP-75
  • Control: Standard of care and normal wound dressing

Treatment groups

78 Participants
are divided into 1 treatment group