Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- DOF Inc.
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of occurrences of pre-determined expected adverse events and complications
研究概览
简要总结
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.
详细描述
The total number of study subjects is 100, with 50 people recruited prospectively into the test group and 50 people retrospectively into the control group.
The test group will consist of 50 patients aged 20 to 80 who have undergone total mastectomy for breast cancer and are scheduled to undergo immediate breast reconstruction using implants. These subjects will receive SC Derm (ADM processed by DOF Inc.) during the implant-based breast reconstruction surgery.
The control group will consist of 50 patients who will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between June 1, 2021, and November 9, 2021.
Patients who fall into the following categories cannot participate in this clinical study because they meet the exclusion criteria:
- Patients who have received an organ transplant and are taking any immunosuppressants.
- Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.
- Individuals who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- Patients for whom the investigator determines participation in the study is not appropriate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
排除标准
- •Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.
- •Patients who have received an organ transplant and are taking any immunosuppressant.
- •Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
- •People who are unable to complete the survey conducted in this clinical study.
- •Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- •If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
结局指标
主要结局
The number of occurrences of pre-determined expected adverse events and complications
时间窗: From the day of operation of breast reconstruction to 12 months
The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group.
次要结局
- Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey(From the day of operation of breast reconstruction to 12 months)