Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- infection rates
研究概览
简要总结
This is a Randomized controlled trial evaluating the effects of the use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery
The trial will randomize 60 patients into an experimental group with HemaClear or Active comparator group with Pneumatic Tourniquet.
The outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ankle and foot surgery
排除标准
- •Infection
- •Open fracture
- •Varicose veins
研究组 & 干预措施
Pneumatic Tourniquet
干预措施: Pneumatic Tourniquet (Device)
HemaClear
干预措施: HemaClear (Device)
结局指标
主要结局
infection rates
时间窗: after 3 months
infection rates
Deep vein thrombosis
时间窗: after 3 months
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
infection rates
时间窗: after 1 week
infection rates
Deep vein thrombosis
时间窗: after 1 week
Deep vein thrombosis (Clinical assessment and Doppler ultrasound)
次要结局
- local pain(after 3 months)
- local pain(after 1 week)