Bedside Pulse Lavage Irrigation Project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Leak
研究概览
简要总结
This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how well the water stream is contained by a new containment device.
详细描述
Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. This study evaluates how well the device contains the spray from pulse lavage and how well subjects with intact skin tolerate pulse lavage when awake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy and willing to complete the study procedures.
排除标准
- •Subjects must not have any chronic pain conditions or take any pain medications on a regular basis. Must not have any chronic wounds. Must not have any medical conditions that interfere with pain sensation. Must not have an allergy to skin adhesives. Patients must not be taking any immunosuppressive medications. Patients must not have any chronic infections.
结局指标
主要结局
Leak
时间窗: up to 1 day
After each lavage treatment, leak will be assessed by the presence of moisture outside of the lavage chamber. The time period of evaluation will take place immediately after the lavage. The subject will not be followed after their visit is complete.
次要结局
- Seals(up to 1 day)
研究者
Robert Galiano
Assistant Professor of Surgery
Northwestern University