After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- DOF Inc.
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale
研究概览
简要总结
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.
详细描述
In South Korea, breast reconstruction using implants or autologous abdominal tissue is commonly performed to address the aesthetic and psychological needs of patients who have undergone total mastectomy for breast cancer. In such procedures, acellular dermal matrix (ADM) is used to compensate for soft tissue and skin deficits resulting from tumor resection.
This clinical study is designed to evaluate differences in clinical efficacy, aesthetic outcomes, and safety between ADM processed using supercritical carbon dioxide technology and conventional ADM products in breast reconstruction surgery.
The test group will prospectively enroll 60 patients undergoing breast reconstruction using SC Derm (an investigational ADM processed with supercritical carbon dioxide technology). The control group will retrospectively include 60 patients who underwent breast reconstruction using other ADM products, based on medical records from 2022.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 20 to 69 scheduled for total mastectomy
- •Patients who are willing to undergo immediate breast reconstruction using implants.
排除标准
- •Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
- •Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
- •Patients who have participated in another clinical trial within 120 days prior to screening.
- •Any other cases where the investigator deems the patient unsuitable for this clinical study.
研究组 & 干预措施
Test Group
Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology).
干预措施: Transplant acellular dermal matrix(ADM) (Biological)
Control Group
The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022.
Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study.
For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study.
干预措施: Transplant acellular dermal matrix(ADM) (Biological)
结局指标
主要结局
Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale
时间窗: 6 months after surgery
Cosmetic outcomes will be independently assessed by two qualified specialists based on standardized breast photographs taken preoperatively and at 6 months postoperatively. The evaluation will include breast shape, volume, symmetry, nipple-areolar complex, and scar. Each item will be scored using a 5-point Likert scale (1-5), where higher scores indicate better cosmetic outcomes: 1. = Very dissatisfied 2. = Dissatisfied 3. = Neutral 4. = Satisfied 5. = Very satisfied The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes.
次要结局
- Complication Assessment(from the operation day to 6 months after surgery)
- Baker's grade of capsular contracture(6 months after surgery)
- Subject's Satisfaction Assessment(Beaseline to 6 months)