Gender Dysphoria, Hypertrophic Scar, Mastectomy
Conditions
Keywords
Gender-affirming, Gender-affirming care, Gender-affirming mastectomy, Hypertrophic scarring
Brief summary
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
DEVICEBrijjit® 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.
OTHERControl: Standard of care and normal wound dressing
The control chest side will receive only standard of care and normal wound dressing.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
While study participants cannot be blinded to the intervention, the operating surgeon will remain blinded to the patient's assignment until final skin closure at the end of the procedure.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Hypertrophic Scarring | 6 weeks postop | Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome. |
| Scar Characteristics | 6 weeks postop | Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised) |
| Scar characteristics | 3 months postop | Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised) |
| Scar Dimensions | 6 weeks postop | Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Scar | 6 weeks postop | Use the Patient and Observer Scar Assessment Scale (POSAS): A validated, widely used questionnaire consisting of both patient and observer scales regarding scar appearance, physical symptoms (e.g. pain, pruritus), and overall patient satisfaction. This scale allows for scores ranging from 1-10, with higher scores meaning a worse outcome. Patients will be given this survey in clinic, but will be given the option of completing it electronically at home. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREsther A Kim, MD
Study Principal Investigator
Outcome results
None listed