Force‑modulating tissue bridge to prevent hypertrophic scars after gender‑affirming double‑incision mastectomy
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial
This study will test whether Brijjit force‑modulating devices applied to one side of the chest after double‑incision gender‑affirming mastectomy reduce hypertrophic scarring compared with standard wound care on the other side.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07147166 on ClinicalTrials.gov |
What this trial studies
This is a randomized, prospective interventional trial at a single institution and single surgeon where each participant serves as their own control (one side receives the device, the other side receives standard care). The intervention uses Brijjit® force‑modulating tissue bridge devices applied to incisions, while consistent silicone‑based tape is encouraged on the control side. Primary endpoints are scar appearance and quality, and secondary endpoints include patient perception measured by the Patient and Observer Scar Assessment Scale (POSAS). Patients are taught how to reapply Brijjit at home if units fall off before six weeks postoperatively.
Who should consider this trial
Good fit: Adults aged 19 or older undergoing double‑incision gender‑affirming mastectomy who can follow device instructions and attend scheduled follow‑up visits are ideal candidates.
Not a fit: Patients with prior chest surgery or radiation, a history of keloids, active smoking, certain medications or medical conditions that impair wound healing, or inability to comply with device use are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could reduce hypertrophic scarring after gender‑affirming mastectomy, improving scar appearance and patient satisfaction while reducing the need for additional scar treatments.
How similar studies have performed: Some prior studies of tension‑reduction devices and silicone‑based therapies have reported improved scar outcomes, but device‑specific evidence for Brijjit/FMTBs is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 19 2. Undergoing double incision gender affirming mastectomy 3. Ability to adhere to Brijjit therapy after surgery 4. Willing to return for follow-up visits and undergo study evaluations Exclusion Criteria: 1. History of keloid formation 2. Radiation therapy history 3. Prior surgeries of the chest or breast 4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids 5. Active smoker 6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes) 7. Any other condition determined by PI to preclude subject from joining study
Where this trial is running
San Francisco, California
- UCSF Department of Plastic & Reconstructive Surgery — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Esther A Kim, MD — Study Principal Investigator
- Study coordinator: Lindsay A Tao, BS
- Email: lindsay.tao@ucsf.edu
- Phone: 4082755270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.