[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prophylactic-mastectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prophylactic-mastectomy":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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","AmnioFix","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":22,"type":23},30,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30,31,32,33],"Mastectomy","Gender Affirmation Surgery","Nipple Sparing Mastectomy","Prophylactic Mastectomy","Benign Breast Condition",[35,36],"nipple sparing mastectomy","gender affirming surgery","NOT_YET_RECRUITING","2026-04-24",{"date":40,"type":41},"2026-04-30","ACTUAL",{"date":43,"type":23},"2026-06-01",{"date":45,"type":23},"2026-09",{"name":47,"class":48},"Stanford University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":49},"100451759","prophylactic-mastectomy-prospective-evaluation-of-the-correlation-between-skin-flap-thickness-residual-glandular-tissue-and-skin-necrosis-by-imaging-and-clinical-examination-100451759","NCT05162677","Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination","Inclusion Criteria:\n\n* Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.\n* Age between 18-74 years\n\nExclusion Criteria:\n\n* Women undergoing mastectomy due to cancer.\n* Age \\\u003C 18 years or \\> 74 years.","FEMALE","18 Years","74 Years",{"count":60,"type":23},45,"OBSERVATIONAL","Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1\u002F2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1\u002F2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1\u002F2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.",[32],"RECRUITING","2024-05-06",{"date":67,"type":41},"2024-05-08",{"date":69,"type":41},"2022-08-25",{"date":71,"type":23},"2027-12-31",{"name":73,"class":48},"Umeå University"]