NCT00758667终止不适用
Chemically Assisted Capsulectomy-A New Clinical Approach
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
研究概览
简要总结
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
详细描述
Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All females undergoing capsulectomy
排除标准
- •All pregnant women and nursing mothers will be exclued
研究组 & 干预措施
Use of Mesna
Experimental
Standard surgical procedure with Mesna
干预措施: Mesna (Drug)
结局指标
主要结局
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
时间窗: one year
次要结局
- Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care(one year)
研究者
R. Bruce Shack
R. Bruce Shack, MD
Vanderbilt University
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