[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Melodi Health, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100518242","melodi-matrix-in-breast-reconstruction-100518242",false,"NCT06027996","Melodi Matrix™ in Breast Reconstruction","Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)","Inclusion Criteria:\n\n* Female.\n* Age 22 or older at the time of enrollment.\n* Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.\n* Is able to and willing to comply with the study requirements and providing informed consent.\n\nExclusion Criteria:\n\n* Has prior history of neoadjuvant radiotherapy.\n* Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.\n* Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.\n* Has a Body Mass Index (BMI) \\\u003C 14 or \\> 40.\n* Is pregnant or is nursing; or plans to become pregnant during the course of the study.\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease.\n* Has known allergies to study device materials.\n* Is participating in another interventional research study that may interfere with study endpoints.\n* Has limited life expectancy or co-morbid conditions, social\u002Fpsychological problems, or cognitive impairments that precludes participation.\n* Has a medical condition or is taking medications that would result in elevated risk and\u002For affect the validity of the study.\n* Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.","FEMALE","22 Years",{"count":19,"type":20},702,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.",[26],"Breast Reconstruction","RECRUITING","2025-12-05",{"date":30,"type":31},"2025-12-08","ACTUAL",{"date":33,"type":31},"2024-08-09",{"date":35,"type":20},"2028-06",{"name":37,"class":38},"Melodi Health, Inc.","INDUSTRY",10,""]