NCT07147166 · University of California, San Francisco
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
(FMTB Brij)
What this study is about
The goal of this randomly assigned, forward-looking, 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).
View original scientific description
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.
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 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.
Presence of Hypertrophic Scarring
Time frame: 3 months 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.
Presence of Hypertrophic Scarring
Time frame: 6 months 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.
Presence of Hypertrophic Scarring
Time frame: 1 year 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
Time frame: 6 weeks postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar characteristics
Time frame: 3 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Characteristics
Time frame: 6 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Characteristics
Time frame: 1 year postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Dimensions
Time frame: 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.
Scar Dimensions
Time frame: 3 months 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.
Scar Dimensions
Time frame: 6 months 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.
Scar Dimensions
Time frame: 1 year 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations