Randomised Controlled Trial: HaemoCerTM Versus no HaemoCerTM in Breast Cancer Surgery to Reduce Postoperative Drainage Output
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Number of days until drain removal (n)
研究概览
简要总结
HaemoCer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. There is however no adequate data available on the efficacy of HaemoCer regarding seroma formation or drainage output. The objective of this study is to investigate whether the intraoperative application of haemostatic powder (HaemoCer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer undergoing breast-conserving surgery
- •No previous breast-conserving surgery on the same site
- •≥ 18 years age
- •no current pregnancy
- •Informed consent
排除标准
- •Patients with previous breast-conserving surgery on the same site
结局指标
主要结局
Number of days until drain removal (n)
时间窗: 7 days
Total volume of postoperative drained fluid (per breast)
时间窗: 7 days
次要结局
- Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection)(7 days)
- Rate of immediate postoperative infection on the breast surgery site(7 days)
研究者
Christian Singer
Univ.-Prof. Dr.med.univ. MPH
Medical University of Vienna