NCT06456554招募中不适用
Acellular Dermal Matrix Investigation in Breast Reconstruction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- RTI Surgical
- 入组人数
- 467
- 试验地点
- 11
- 主要终点
- Health related quality of life
研究概览
简要总结
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Genetic female
- •Age 22 or older at time of consent
- •Undergoing immediate breast reconstruction
- •2 stage breast reconstruction using pre pectoral technique
- •Nipple or skin sparing mastectomy
- •Willing and capable of providing informed consent
- •Able to comply with study requirements
排除标准
- •Planned concurrent reconstruction with pedicled flaps or free tissue
- •Pregnant or breast feeding
- •Investigator has determined tissue is unsuitable for two-stage breast reconstruction
- •History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
- •Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
- •Vulnerable subject populations
- •Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
- •Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
- •Active abscess or infection in the intended reconstruction site
- •Residual gross tumor at the intended reconstruction site
- •Active use of any tobacco/nicotine products
- •Has body mass index (BMI) >35
- •Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
- •Is currently taking medications including systemic steroids
研究组 & 干预措施
no Acellular Dermal Matrix
No Intervention
Breast reconstruction only with no ADM
Acellular Dermal Matrix
Experimental
Breast reconstruction with Cortiva Tissue Matrix
干预措施: Acellular Dermal Matrix (Cortiva Tissue Matrix) (Device)
结局指标
主要结局
Health related quality of life
时间窗: 12 months
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Rate of major adverse events
时间窗: 12 months
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
次要结局
- Histopathology assessment(stage 2 procedure)
- Investigational device related adverse events(3 months, 1 year and 2 years)
- Change in quality of life(1 year and 2 years)
- Procedure related adverse events(3 months, 1 year and 2 years)
研究者
研究点 (11)
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