Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acellular Dermal Matrix (SureDerm BCS), Standard Breast-Conserving Surgery.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Mastectomy, Segmental. Basic parameters: 20 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery
Overview
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
Interventions
- 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. - 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.
Primary outcome measures
- Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q [Time frame: Baseline, 1 month after surgery, and 12 months after surgery]
Secondary outcome measures (3)
- Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm [Time frame: 1 month after surgery, and 12 months after surgery]
- Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction [Time frame: 1 month and 12 months after surgery]
- Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale [Time frame: 1 month and 12 months after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Seoul
Publications
- Kwon J, Byon JH, Ko BK, Kim JS, Bang M. Clinical progression following acellular dermal matrix use for volume replacement after breast-conserving surgery. BMC Surg. 2025 Mar 5;25(1):91. doi: 10.1186/s12893-025-02821-z. PMID 40045324
- Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807. PMID 19644246
Identifiers
NCT: NCT07345026 · XC25EIDV0042