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临床试验/NCT04825314
NCT04825314Unknown不适用

Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study

Alexandria University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Urinary tract infection

研究概览

简要总结

Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock.

This study will be conducted up on 100 patients (50 per each group) with long term catheterization to assess efficacy of noble metal alloy coated catheter in reducing CAUTI.

详细描述

This prospective controlled randomized study conducted upon 100 patients at Alexandria University hospital from 21 May 2020 to 21 December 2020. Patients enrolled will be divided into two equal groups according to the urethral catheter inserted

The institutional ethics committee for research approved the study. Written informed consent was obtained from all participants. In addition to taking the patients' medical history and completing general and physical examinations, physicians will choose proper catheter size all perform catheterization using aseptic technique according to guidelines of proper aseptic catheterization. Urologist ensures comparable catheter size and amount of balloon inflation.

An aseptic non-touch technique (ANTT) must be used to obtain catheter specimen urine following these steps:

  • After catheterization apply clamp 10 cm distal to meatus then after few minutes clean the drainage port with alcohol and allow to dry then insert the syringe tip into the drainage port.
  • Three to five ml of urine collected in sterile disposable plastic cup at day zero (within 2 hours of catheterization), day ten and day twenty post catheterization.
  • The urine subjected to routine urine analysis, urine culture and sensitivity.

Appropriate statistical tests will be used to indicate the frequency and type of CAUTI as well as to assess catheter tolerance in each arm, followed by a comparison to conclude the results.

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 (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.

排除标准

  • Patients with current or recent symptomatic urinary tract infection.
  • Antibiotic use currently or within 7 days prior to inclusion.
  • Known hypersensitivity to latex, silver salts or hydrogel.
  • Patients with recent surgical intervention in the urinary tract.
  • Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.)
  • Uncontrolled DM. Patients on corticosteroid treatment. Immunosuppressed patients. Patients received pelvic irradiation.

结局指标

主要结局

Urinary tract infection

时间窗: 14 days

incidence of culture documented symotomatic urinary tract infection

次要结局

  • Catheter tolerance(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Abou Youssif

Associate Professor

Alexandria University

研究点 (2)

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