[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521762":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":59,"collaborators":32,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":89,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Assess dHACM viability","EXPERIMENTAL","Implantation of dHACM in patients during Nipple Sparing Mastectomy; test arm. The device will be implanted in one breast per patient during bilateral nipple sparing mastectomy.",[13],"Device: AmnioFix dehydrated Human Amnion\u002FChorion Membrane Allograft",{"label":15,"type":16,"description":17,"interventionNames":18},"Assess dHACM effectiveness against control device","ACTIVE_COMPARATOR","Implantation of control device in patients during Nipple Sparing Mastectomy; control arm. The device will be implanted in one breast per patient during bilateral nipple sparing mastectomy.",[19],"Device: Control Device",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","AmnioFix dehydrated Human Amnion\u002FChorion Membrane Allograft","Dehydrated human amnion\u002Fchorion membrane (dHACMs) allografts have recently been identified as an easy-to-use treatment alternative for management of chronic wounds. These commercially available allografts contain concentrated cytokines and growth factors known to promote wound healing. Preclinical studies suggest that dHACM allografts provide a complex, biologically-driven mechanism to promote soft tissue repair and regeneration, including stimulation of mesenchymal stem cell migration and dermal fibroblast proliferation, establishment of a supportive inflammatory environment, and restoration of extracellular matrix integrity with positive tissue architecture remodeling. Clinically, dHACM allografts have been shown to improve healing time and wound closure rates in chronic wound patients. However, no study to date has evaluated the impact of dHACM allografts on nipple necrosis following NSM.",[9],[27],"AmnioFix",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Control Device","Control device will be applied to non-experimental breast. Each patient will serve as their own control.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Dung Nguyen, MD, PharmD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Kassandra Carrion","CONTACT","650-498-6004","kcarrion@stanford.edu",{"name":35,"role":40,"phone":32,"phoneExt":32,"email":44},"nguyendh@stanford.edu",[46],{"facility":47,"status":32,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":32},"Division of Plastic & Reconstructive Surgery","Palo Alto","California","94304","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.14302,37.44188,{"lat":57,"lon":56},{"type":36,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Dung Nguyen","Clinical Professor, Director of Breast Reconstruction, Director of Adult Plastics and Reconstructive Clinic, Associate Director of Microsurgery","100521762","the-role-of-amnion-membrane-allografts-in-nipple-preservation-100521762",false,"NCT06073808","The Role of Amnion Membrane Allografts in Nipple Preservation","The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.\n* Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.\n\nExclusion Criteria:\n\n* Current steroid use\n* Known connective tissue disorder\n* Known neuropathy\n* Known history of breast cancer\n* History of breast radiotherapy\n* Pregnant or nursing",true,"ALL","15 Years","75 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion\u002Fchorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.",[81,82,83,84,85],"Mastectomy","Gender Affirmation Surgery","Nipple Sparing Mastectomy","Prophylactic Mastectomy","Benign Breast Condition",[87,88],"nipple sparing mastectomy","gender affirming surgery","NOT_YET_RECRUITING","2026-04-24",{"date":92,"type":93},"2026-04-30","ACTUAL",{"date":95,"type":75},"2026-06-01",{"date":97,"type":75},"2026-09",{"name":5,"class":6},1]