[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07147166":3,"trial-entities:NCT07147166":124,"trial-summary:NCT07147166":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":69,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":84,"locations":87,"central_contacts":97,"overall_officials":98,"references":103,"see_also_links":111},"NCT07147166","24-43094","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","TERMINATED","2026-08-18","2026-08","2026-08-25","2025-02-03","University of California, San Francisco","OTHER",false,"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.","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.\n\nWe 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.",[19,20,21],"Gender Dysphoria","Mastectomy","Hypertrophic Scar",[23,24,25,26],"Gender-affirming","Gender-affirming care","Gender-affirming mastectomy","Hypertrophic scarring","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},7,"ACTUAL",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"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.",[40],"Self-control Brijjit Application and Control",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Control: Standard of care and normal wound dressing","The control chest side will receive only standard of care and normal wound dressing.",[40],[46,50,52,54,56,59,61,62,63,66,67,68],{"measure":47,"description":48,"timeFrame":49},"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 \\>\u002F= 1mm. Binary yes or no outcome.","6 weeks postop",{"measure":47,"description":48,"timeFrame":51},"3 months postop",{"measure":47,"description":48,"timeFrame":53},"6 months postop",{"measure":47,"description":48,"timeFrame":55},"1 year postop",{"measure":57,"description":58,"timeFrame":49},"Scar Characteristics","Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)",{"measure":60,"description":58,"timeFrame":51},"Scar characteristics",{"measure":57,"description":58,"timeFrame":53},{"measure":57,"description":58,"timeFrame":55},{"measure":64,"description":65,"timeFrame":49},"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.",{"measure":64,"description":65,"timeFrame":51},{"measure":64,"description":65,"timeFrame":53},{"measure":64,"description":65,"timeFrame":55},[70,73,74,75],{"measure":71,"description":72,"timeFrame":49},"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.",{"measure":71,"description":72,"timeFrame":51},{"measure":71,"description":72,"timeFrame":53},{"measure":71,"description":72,"timeFrame":55},"ALL","19 Years",null,true,{"inclusion":81,"exclusion":82,"raw_text":83},[],[],"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",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"UCSF Department of Plastic & Reconstructive Surgery","San Francisco","California","94131","United States",{"lat":95,"lon":96},37.77493,-122.41942,[],[99],{"name":100,"affiliation":101,"role":102},"Esther A Kim, MD","Study Principal Investigator","PRINCIPAL_INVESTIGATOR",[104,108],{"pmid":105,"type":106,"citation":107},"37606245","BACKGROUND","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\u002Fasj\u002Fsjad269.",{"pmid":109,"type":106,"citation":110},"39559183","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\u002FCCID.S496253. eCollection 2024.",[112,115,118,121],{"label":113,"url":114},"Tension Reduction With Force Modulating Tissue Bridges Reduces Wound Formation in Elective Breast Surgery","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F37652052\u002F",{"label":116,"url":117},"Mechanomodulation of Wound Healing: Current Perspectives and Future Directions","https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jid.2021.10.003",{"label":119,"url":120},"Silicone in Scar Prevention and Treatment: A Review of Current Evidence","https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.bjps.2015.09.013",{"label":122,"url":123},"Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC5792236\u002F",{"nct_id":4,"conditions":125,"biomarkers":126},[19],[],{"nct_id":4,"found":79,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a randomized study involving 78 participants. Each participant will have the Brijjit® device on one side of their chest and standard care on the other side.","completed","Brijjit® Device for Preventing Scars After Gender-Affirming Mastectomy","This study is testing a device called Brijjit® (BP100-6 and BP-75) to see if it can help prevent thick, raised scars (hypertrophic scars) after gender-affirming mastectomy. The Brijjit® device is a flexible, non-invasive tool that helps wounds heal. You could be eligible if you are at least 19 years old, having a double incision gender-affirming mastectomy, and can follow the study instructions and attend follow-up visits. The study will compare how well the Brijjit® device works on one side of your chest versus standard wound care on the other side. Researchers will check for hypertrophic scars at 6 weeks, 3 months, and 6 months after surgery. The goal is to see if Brijjit® can reduce scarring.","Participants will be followed for 6 months after surgery, with scar assessments at 6 weeks, 3 months, and 6 months.",116,"You would need to apply the Brijjit® device after surgery and be willing to return for follow-up visits and study evaluations. You will be taught how to reapply the device at home if needed.","Not stated in the trial record.",[],"v2"]