Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Total volume in milliliters (ml) of drainage
研究概览
简要总结
Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hemopatch Group:
Hemopatch + suction drainage
干预措施: Hemopatch (Device)
Control group
No sealant (liquid, gel or patch) + suction drain
干预措施: Control group (Other)
结局指标
主要结局
Total volume in milliliters (ml) of drainage
时间窗: In the last 24 hours
Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain.
次要结局
未报告次要终点