[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586881":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":38,"responsibleParty":55,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":23,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":23,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":23,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sylk Wound Dressing","EXPERIMENTAL","Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond\u002FPrineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.",[13],"Device: Sylk Wound Dressing",{"label":15,"type":10,"description":11,"interventionNames":16},"Dermabond\u002FPrineo Dressing",[17],"Device: Dermabond\u002FPrineo Dressing",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond\u002FPrineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.",[9],null,{"type":20,"name":15,"description":21,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"affiliation":5,"role":29},"Ivan Hadad, MD","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":23,"email":34},"CONTACT","(317) 944-5000","ihadad@iu.edu",{"name":36,"role":32,"phone":33,"phoneExt":23,"email":37},"Parhom Towfighi, MD","ptowfigh@iu.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Indiana University Health","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-86.15804,39.76838,{"lat":51,"lon":50},[54],{"name":28,"role":32,"phone":33,"phoneExt":23,"email":34},{"type":29,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ivan Hadad","Assistant Professor of Clinical Surgery","100586881","silk-bioprotein-as-a-wound-dressing-for-double-incision-mastectomy-100586881",false,"NCT06921148","Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy","The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy","Inclusion Criteria:\n\n* Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.\n* Physicians will be plastic surgeons in the IU Health system\n\nExclusion Criteria:\n\n* Patients with a history of breast cancer.\n* Patients with prior history of breast surgery.\n* Patients with a prior history of radiation to the chest wall\u002Fbreast.\n* Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).\n* Patients with a history of documented allergic reaction to Dermabond\u002FPrineo or Silk Bioprotein dressing, or any of the constituents that make up these dressings.\n* Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.\n* Physicians not in the IU Health system will not be included.","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.",[75],"Wound Healing","2026-06-05",{"date":78,"type":79},"2026-06-09","ACTUAL",{"date":81,"type":79},"2025-04-30",{"date":83,"type":69},"2028-06-14",{"name":5,"class":6},1]