The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Bacterial Colonization
研究概览
简要总结
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.
详细描述
This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.
Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.
At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The UroShield device actuator will activate and create the hum, which is the only sign of its working even in the active device. While the active device will transmit Surface Acoustic Waves, the sham device will work but will not transmit any acoustic waves.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently being treated with an indwelling urinary catheter for at least 30 days.
- •Ability to sign informed consent or have someone authorized to sign informed consent.
排除标准
- •Currently being treated for an active Urinary Tract infection.
- •Previous treatment with Surface Acoustic Waves.
结局指标
主要结局
Bacterial Colonization
时间窗: 30 days
Number of cultured colonies from both the Urinary Catheter and retained urine
次要结局
未报告次要终点