NCT07147166

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
72mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2025Jun 2032

Study Start

First participant enrolled

February 3, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

7.3 years

First QC Date

July 29, 2025

Last Update Submit

June 2, 2026

Conditions

Hypertrophic ScarMastectomyGender Dysphoria

Keywords

Gender-affirmingGender-affirming careGender-affirming mastectomyHypertrophic scarring

Outcome Measures

Primary Outcomes (12)

  • 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.

    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.

    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.

    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.

    1 year postop

  • Scar Characteristics

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

    6 weeks postop

  • Scar characteristics

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

    3 months postop

  • Scar Characteristics

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

    6 months postop

  • Scar Characteristics

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

    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.

    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.

    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.

    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.

    1 year postop

Secondary Outcomes (4)

  • Patient Perception of Scar

    6 weeks postop

  • Patient Perception of Scar

    3 months postop

  • Patient Perception of Scar

    6 months postop

  • Patient Perception of Scar

    1 year postop

Study Arms (1)

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.

Device: Brijjit® BP100-6 and BP-75Other: Control: Standard of care and normal wound dressing

Interventions

Control: Standard of care and normal wound dressingOTHER

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

Self-control Brijjit Application and Control
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.

Self-control Brijjit Application and Control

Eligibility Criteria

Age19 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentifying as transgender, gender expansive, or non-binary
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Department of Plastic & Reconstructive Surgery

San Francisco, California, 94131, United States

RECRUITING

Related Publications (2)

  • 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: 37606245BACKGROUND

  • 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: 39559183BACKGROUND

Related Links

MeSH Terms

Conditions

Gender DysphoriaCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental DisordersCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Esther A Kim, MD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan S Ramrakhiani, BS

CONTACT

6507760834nathan.ramrakhiani@ucsf.edu

Lindsay A Tao, BS

CONTACT

7603300915lindsay.tao@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Esther A. Kim, MD

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 28, 2025

Study Start

February 3, 2025

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2032

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)