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NCT Number: NCT07147166

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy

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.

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Key information

Conditions

Gender Dysphoria Cicatrix Cicatrix, Hypertrophic Fibrosis Hypertrophic Scar Mastectomy Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Dysfunctions, Psychological

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Department of Plastic & Reconstructive Surgery

San Francisco, California, 94131, United States

Location status: Recruiting

Location contact

Esther A Kim, MD

CONTACT

[email protected]

(415) 353-4201

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brijjit® BP100-6 and BP-75

Device

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 dressing

Other

The control chest side will receive only standard of care and normal wound dressing.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Scar Characteristics

    Time frame: 6 weeks postop

    Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)

  6. Scar characteristics

    Time frame: 3 months postop

    Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)

  7. Scar Characteristics

    Time frame: 6 months postop

    Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)

  8. Scar Characteristics

    Time frame: 1 year postop

    Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Patient Perception of Scar

    Time frame: 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.

  2. Patient Perception of Scar

    Time frame: 3 months 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.

  3. Patient Perception of Scar

    Time frame: 6 months 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.

  4. Patient Perception of Scar

    Time frame: 1 year 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay A Tao, BS

CONTACT

[email protected]

7603300915

Nathan S Ramrakhiani, BS

CONTACT

[email protected]

6507760834

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial

Acronym: FMTB Brij

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Aug 28, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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