Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
Starting soon · Not applicable
Conditions studied: Breast Neoplasms, Mastectomy, Segmental
In brief
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. The main questions it aims to answer are: 1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery? 2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm? Researchers 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. Participants will: * Undergo breast-conserving surgery, with or without SureDerm (assigned randomly) * Receive standard postoperative radiotherapy * Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery * Be followed for complications and cosmetic assessments by physicians
Key facts
- Study ID
- NCT07345026
- Run by
- Seoul St. Mary's Hospital
- People needed
- 116
- Starts
- 2026-01-08
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2026-01-15
Who can join
Age: 20 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female patients aged 20 to 75 years
- Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery
- Agreed to the use of acellular dermal matrix (ADM) during surgery
- Histologically confirmed primary breast cancer
- Patients who received neoadjuvant chemotherapy are eligible
- Planned to receive standard postoperative treatment, including adjuvant radiotherapy
- Voluntarily decided to participate in the study and provided written informed consent
You may not qualify if…
- Evidence of distant metastasis
- Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding/coagulation disorders
- Known adverse reactions to all first-line antibiotics
- Suspected inflammatory infection of the breast prior to surgery
- Pregnant women at the time of enrollment
- Definite contraindications to the use of acellular dermal matrix
- Contraindications to radiotherapy
- Male patients
- History of another malignancy diagnosed within the past 5 years
- Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator
- Patients unable to understand or complete the study questionnaires
Where it is running
- Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Seoul, Seoul, South Korea
Full record on ClinicalTrials.gov
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