Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mastectomy, Segmental | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular Dermal Matrix (SureDerm BCS) | Device | — | UNRESOLVED |
| Standard Breast-Conserving Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast-Conserving Surgery With SureDerm
- description
- Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.
- interventionNames
- Device: Acellular Dermal Matrix (SureDerm BCS)
- type
- ACTIVE_COMPARATOR
- label
- Breast-Conserving Surgery Without SureDerm
- description
- Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.
- interventionNames
- Procedure: Standard Breast-Conserving Surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTKwon 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
- RESULTPusic 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