Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brijjit® BP100-6 and BP-75, Control: Standard of care and normal wound dressing.
- Who it may be relevant to
- Registry conditions: Gender Dysphoria, Mastectomy, Hypertrophic Scar. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial
Overview
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.
Detailed description
The hypothesis of this study is that the use of Brijjit® Force-Modulating Tissue Bridge devices will reduce the incidence of hypertrophic scarring as measured by objective and subjective factors compared to no intervention following gender-affirming double incision mastectomy. Patients will serve as self-controls (one side of the chest will receive the intervention, the other will not). Consistent use of silicone-based tape, the current gold standard for wound care, will be encouraged on the control side of the chest.
We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing. Should our hypotheses be proven, this study will provide a compelling reason to implement Brijjit therapy into standard clinical practice as a non-invasive preventative measure to improve scar outcomes.
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.
Primary outcome measures
- Presence of Hypertrophic Scarring [Time frame: 6 weeks postop]
- Presence of Hypertrophic Scarring [Time frame: 3 months postop]
- Presence of Hypertrophic Scarring [Time frame: 6 months postop]
- Presence of Hypertrophic Scarring [Time frame: 1 year postop]
- Scar Characteristics [Time frame: 6 weeks postop]
- Scar characteristics [Time frame: 3 months postop]
- Scar Characteristics [Time frame: 6 months postop]
- Scar Characteristics [Time frame: 1 year postop]
- Scar Dimensions [Time frame: 6 weeks postop]
- Scar Dimensions [Time frame: 3 months postop]
Secondary outcome measures (4)
- Patient Perception of Scar [Time frame: 6 weeks postop]
- Patient Perception of Scar [Time frame: 3 months postop]
- Patient Perception of Scar [Time frame: 6 months postop]
- Patient Perception of Scar [Time frame: 1 year postop]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Active smoker
- Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
- Any other condition determined by PI to preclude subject from joining study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UCSF Department of Plastic & Reconstructive Surgery — San Francisco
Publications
- Panton J, Vingan N, Barillas J, Akgul Y, Lazzarini A, Coroneos CJ, Amirlak B, Kenkel J, Culver A. Postoperative Mechanomodulation Decreases T-Junction Dehiscence After Reduction Mammaplasty: Early Scar Analysis From a Randomized Controlled Trial. Aesthet Surg J. 2023 Nov 16;43(12):NP1033-NP1048. doi: 10.1093/asj/sjad269. PMID 37606245
- Cao G, Ye M, Wang H, Liu Y, Li M. The Role of Biomechanical Forces in the Formation and Treatment of Pathological Scars. Clin Cosmet Investig Dermatol. 2024 Nov 13;17:2565-2571. doi: 10.2147/CCID.S496253. eCollection 2024. PMID 39559183
Identifiers
NCT: NCT07147166 · 24-43094