[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619469":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":46,"responsibleParty":60,"collaborators":35,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":35,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":35,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":88,"whyStopped":35,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Seoul St. Mary's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast-Conserving Surgery With SureDerm","EXPERIMENTAL","Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.",[13],"Device: Acellular Dermal Matrix (SureDerm BCS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Breast-Conserving Surgery Without SureDerm","ACTIVE_COMPARATOR","Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.",[19],"Procedure: Standard Breast-Conserving Surgery",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Acellular Dermal Matrix (SureDerm BCS)","Participants in this arm will undergo breast-conserving surgery with placement of an acellular dermal matrix (SureDerm BCS). The device is implanted during surgery to provide soft tissue support and improve cosmetic outcomes. All participants will also receive standard postoperative radiotherapy.",[9],[27],"Acellular Dermal Matrix",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Standard Breast-Conserving Surgery","Participants in this arm will undergo standard breast-conserving surgery without the use of acellular dermal matrix. This procedure involves removal of the breast tumor with preservation of most of the breast tissue. All participants will also receive standard postoperative radiotherapy.",[15],[34],"Lumpectomy",null,[37,42],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Chang Ik Yoon, MD, PhD","CONTACT","+82-2-2258-6109","fayn03@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":35,"email":45},"Jin Ah Lee, MD","+82-2-2258-6333","jinah8908@gmail.com",[47],{"facility":48,"status":35,"city":49,"state":49,"zip":50,"country":51,"countryCode":35,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea","Seoul","06591","South Korea",{"type":53,"coordinates":54},"Point",[55,56],126.9784,37.566,{"lat":56,"lon":55},[59],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Chang-Ik Yoon","Assistant Professor","100619469","acellular-dermal-matrixsurederm-bcs-in-breast-conserving-surgery-for-breast-cancer-patients-100619469",false,"NCT07345026","Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients","Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery","Inclusion Criteria:\n\n* Female patients aged 20 to 75 years\n* Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery\n* Agreed to the use of acellular dermal matrix (ADM) during surgery\n* Histologically confirmed primary breast cancer\n* Patients who received neoadjuvant chemotherapy are eligible\n* Planned to receive standard postoperative treatment, including adjuvant radiotherapy\n* Voluntarily decided to participate in the study and provided written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding\u002Fcoagulation disorders\n* Known adverse reactions to all first-line antibiotics\n* Suspected inflammatory infection of the breast prior to surgery\n* Pregnant women at the time of enrollment\n* Definite contraindications to the use of acellular dermal matrix\n* Contraindications to radiotherapy\n* Male patients\n* History of another malignancy diagnosed within the past 5 years\n* Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator\n* Patients unable to understand or complete the study questionnaires","FEMALE","20 Years","75 Years",{"count":75,"type":76},116,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery.\n\nThe main questions it aims to answer are:\n\n1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?\n2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm?\n\nResearchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups.\n\nParticipants will:\n\n* Undergo breast-conserving surgery, with or without SureDerm (assigned randomly)\n* Receive standard postoperative radiotherapy\n* Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery\n* Be followed for complications and cosmetic assessments by physicians",[82,83],"Breast Neoplasms","Mastectomy, Segmental",[85,86,27,87],"Breast Cancer","Breast-Conserving Surgery","Oncoplastic Surgery","NOT_YET_RECRUITING","2026-01-07",{"date":91,"type":92},"2026-01-15","ACTUAL",{"date":94,"type":76},"2026-01-08",{"date":96,"type":76},"2028-04-30",{"name":5,"class":6},1]