[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604257":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":21,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":21,"enrollmentInfo":74,"targetDuration":21,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nThe control chest side will receive only standard of care and normal wound dressing.",[13,14],"Device: Brijjit® BP100-6 and BP-75","Other: Control: Standard of care and normal wound dressing",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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.",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Control: Standard of care and normal wound dressing","The control chest side will receive only standard of care and normal wound dressing.",[9],[27],{"name":28,"affiliation":29,"role":30},"Esther A Kim, MD","Study Principal Investigator","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Nathan S Ramrakhiani, BS","CONTACT","6507760834","nathan.ramrakhiani@ucsf.edu",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Lindsay A Tao, BS","7603300915","lindsay.tao@ucsf.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"UCSF Department of Plastic & Reconstructive Surgery","RECRUITING","San Francisco","California","94131","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-122.41942,37.77493,{"lat":54,"lon":53},[57],{"name":28,"role":34,"phone":58,"phoneExt":21,"email":59},"(415) 353-4201","Esther.kim@ucsf.edu",{"type":30,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Esther Kim, MD","Esther A. Kim, MD","100604257","evaluating-the-efficacy-of-force-modulating-tissue-bridge-device-in-preventing-hypertrophic-scars-following-gender-affirming-mastectomy-100604257",false,"NCT07147166","Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy","Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial","FMTB Brij","Inclusion Criteria:\n\n1. Age ≥ 19\n2. Undergoing double incision gender affirming mastectomy\n3. Ability to adhere to Brijjit therapy after surgery\n4. Willing to return for follow-up visits and undergo study evaluations\n\nExclusion Criteria:\n\n1. History of keloid formation\n2. Radiation therapy history\n3. Prior surgeries of the chest or breast\n4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids\n5. Active smoker\n6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)\n7. Any other condition determined by PI to preclude subject from joining study",true,"ALL","19 Years",{"count":75,"type":76},78,"ESTIMATED","INTERVENTIONAL",[79],"NA","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).\n\nParticipants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.",[82,83,84],"Gender Dysphoria","Mastectomy","Hypertrophic Scar",[86,87,88,89],"Gender-affirming","Gender-affirming care","Gender-affirming mastectomy","Hypertrophic scarring","2026-06-02",{"date":92,"type":93},"2026-06-04","ACTUAL",{"date":95,"type":93},"2025-02-03",{"date":97,"type":76},"2032-06-01",{"name":5,"class":6},1]