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