RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09-20
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07147166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 19
  2. 2. Undergoing double incision gender affirming mastectomy
  3. 3. Ability to adhere to Brijjit therapy after surgery
  4. 4. Willing to return for follow-up visits and undergo study evaluations
  1. 1. History of keloid formation
  2. 2. Radiation therapy history
  3. 3. Prior surgeries of the chest or breast
  4. 4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
  5. 5. Active smoker
  6. 6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
  7. 7. Any other condition determined by PI to preclude subject from joining study

Contacts and Locations

Study Contact

Lindsay A Tao, BS
CONTACT
4082755270
lindsay.tao@ucsf.edu
Carolyn Cafro, BS
CONTACT
7603300915
carolyn.cafro@ucsf.edu

Principal Investigator

Esther A Kim, MD
PRINCIPAL_INVESTIGATOR
Study Principal Investigator

Study Locations (Sites)

UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, 94131
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Esther A Kim, MD, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-20
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2025-09-20
Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

  • Gender-affirming
  • Gender-affirming care
  • Gender-affirming mastectomy
  • Hypertrophic scarring

Additional Relevant MeSH Terms

  • Gender Dysphoria
  • Mastectomy
  • Hypertrophic Scar