Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- DOF Inc.
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
研究概览
简要总结
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.
详细描述
Outline:
The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.
The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.
The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.
After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prospective Subjects (Test Group):
- •Female patients aged 19 to 79 years
- •Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
- •Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits
- •Retrospective Medical Record Collection (Control Group):
- •Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
- •Availability of medical records between March 1, 2021, and March 31, 2024
排除标准
- •Prospective Subjects (Test Group):
- •- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)
- •Retrospective Medical Record Collection (Control Group):
- •- Patients with no recorded follow-up visits after application of the acellular dermal matrix
研究组 & 干预措施
Test Group
A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology.
干预措施: Acellular Dermal Matrix(ADM) (Other)
Control Group
A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents.
干预措施: Acellular Dermal Matrix(ADM) (Other)
结局指标
主要结局
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
时间窗: From the day of operation of breast reconstruction to 12weeks
The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).
次要结局
未报告次要终点