Gender DysphoriaFMTB BrijNCT07147166
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
A study testing Brijjit® BP100-6 and BP-75 in people with Gender Dysphoria and Mastectomy, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria, Mastectomy, Hypertrophic Scar
- What is being tested?
- Brijjit® BP100-6 and BP-75
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, 94131
About this study
Official title: Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled 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.
Read the 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.
- Conditions
- Gender Dysphoria, Mastectomy, Hypertrophic Scar
- Being tested
- Brijjit® BP100-6 and BP-75, Control: Standard of care and normal wound dressing
- Keywords
- Gender-affirming, Gender-affirming care, Gender-affirming mastectomy, Hypertrophic scarring
- Medical subject headings
- Gender Dysphoria, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brijjit® BP100-6 and BP-75Device
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.
Control: Standard of care and normal wound dressingOther
The control chest side will receive only standard of care and normal wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| Self-control Brijjit Application and Control | Experimental | The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides.
The control chest side will receive only standard of care and normal wound dressing. Receives: Device: Brijjit® BP100-6 and BP-75; Other: Control: Standard of care and normal wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Hypertrophic Scarring
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.
Measured: 6 weeks postop
Presence of Hypertrophic Scarring
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.
Measured: 3 months postop
Presence of Hypertrophic Scarring
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.
Measured: 6 months postop
Presence of Hypertrophic Scarring
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.
Measured: 1 year postop
Scar Characteristics
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Measured: 6 weeks postop
Scar characteristics
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Measured: 3 months postop
Scar Characteristics
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Measured: 6 months postop
Scar Characteristics
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Measured: 1 year postop
Scar Dimensions
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.
Measured: 6 weeks postop
Scar Dimensions
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.
Measured: 3 months postop
Scar Dimensions
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.
Measured: 6 months postop
Scar Dimensions
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.
Measured: 1 year postop
Secondary outcomes (4)
Patient Perception of Scar
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.
Measured: 6 weeks postop
Patient Perception of Scar
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.
Measured: 3 months postop
Patient Perception of Scar
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.
Measured: 6 months postop
Patient Perception of Scar
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.
Measured: 1 year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Feb 2025
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Why it stopped: Insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Kim, MD, University of California, San Francisco
- Investigators
- Esther A Kim, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147166
- Sponsor's protocol ID
- 24-43094
- Acronym
- FMTB Brij
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 37606245Cao 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.
PubMed 39559183
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial
- ClinicalTrials.gov ID
- NCT07147166
- Acronym / sponsor ID
- FMTB Brij / 24-43094
- Conditions
- Gender Dysphoria, Mastectomy, Hypertrophic Scar
- Keywords
- Gender-affirming, Gender-affirming care, Gender-affirming mastectomy, Hypertrophic scarring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-control Brijjit Application and Control | Experimental | Device: Brijjit® BP100-6 and BP-75, Other: Control: Standard of care and normal wound dressingThe side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides. The control chest side will receive only standard of care and normal wound dressing. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brijjit® BP100-6 and BP-75Brijjit® 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. | Device | Self-control Brijjit Application and Control |
| Control: Standard of care and normal wound dressingThe control chest side will receive only standard of care and normal wound dressing. | Other | Self-control Brijjit Application and Control |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 37606245Panton 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.
- Background: PubMed 39559183Cao 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.
- Tension Reduction With Force Modulating Tissue Bridges Reduces Wound Formation in Elective Breast SurgeryLink provided by the sponsor.
- Mechanomodulation of Wound Healing: Current Perspectives and Future DirectionsLink provided by the sponsor.
- Silicone in Scar Prevention and Treatment: A Review of Current EvidenceLink provided by the sponsor.
- Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar FormationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther A Kim, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brijjit® BP100-6 and BP-75 in people with Gender Dysphoria and Mastectomy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Hypertrophic Scarring (time frame: 6 weeks postop). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.