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临床试验/NCT02412891
NCT02412891撤回不适用

Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

HaEmek Medical Center, Israel0 个研究点开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
side effects and complications of urinary catheter usage

研究概览

简要总结

Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.

The use of urinary catheters is a common medical practice in the perioperative setting.

As such, it exposes the patient to certain comorbidities, including urinary tract infections.

The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.

Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

排除标准

  • Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
  • patients with a urinary tract infection in the past year.
  • Patients with a urinary tract infection when inserting a catheter.
  • pregnant women.
  • Patients under the age of
  • without judgment.

结局指标

主要结局

side effects and complications of urinary catheter usage

时间窗: One Year

the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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