Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q
研究概览
简要总结
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:
- Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Breast-Conserving Surgery With SureDerm
Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.
干预措施: Acellular Dermal Matrix (SureDerm BCS) (Device)
Breast-Conserving Surgery Without SureDerm
Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.
干预措施: Standard Breast-Conserving Surgery (Procedure)
结局指标
主要结局
Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q
时间窗: Baseline, 1 month after surgery, and 12 months after surgery
Patient-reported cosmetic satisfaction will be assessed using the validated Breast-Q (Breast-Conserving Therapy Module) questionnaire at baseline (before surgery), 1 month after surgery, and 12 months after surgery. Scores will be reported as transformed scale scores ranging from 0 to 100, with higher scores indicating greater satisfaction. The change in scores over time will be analyzed.
次要结局
- Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm(1 month after surgery, and 12 months after surgery)
- Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction(1 month and 12 months after surgery)
- Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale(1 month and 12 months after surgery)
研究者
Chang-Ik Yoon
Assistant Professor
Seoul St. Mary's Hospital