跳至主要内容
临床试验/CTRI/2021/05/033310
CTRI/2021/05/033310尚未招募不适用

Bactriguard catheter versus Foleys catheter in reduction of UTI among Urethroplasty patients, at AIIMS, BBSR Randomized controlled trial

ICMR1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2021年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
178
试验地点
1
主要终点
Rates of post-op UTI

研究概览

简要总结

The risk of CAUTI increases with the number of days of catheterization and if the patients´s immune system is weak. Groups at risk of CAUTI  include the critically ill and patients with urological  obstruction ,malignancies and neurological diseases.

BIP Foley Catheter has been shown to reduce CAUTI in a cost effective way. Several health economic evaluations have been conducted in Europe and USA. In one of these, a large, prospective, randomized study of almost 28 000 patients, Bactiguard coated catheters were shown to offer significant annual cost savings when considering the excess cost of CAUTI. In another 2-year prospective surveillance study of 10 patient care units, the introduction of a Bactiguard coated urinary catheter was associated with a significant decline in CAUTI and led to reduced costs. The costs savings were present in a wide variety of reimbursement systems.

Bactiguard coated products have been used in a large number of clinical studies and evaluations (1986–2015) involving over 100,000 patients. In peer-reviewed studies looking specific on the  reduction of  CAUTI. In another 2-year prospective surveillance study of 10 patient care units, the introduction of a Bactiguard coated urinary catheter was associated with a significant decline in CAUTI and led to reduced costs.

The costs savings were present in a wide variety of reimbursement at the incidence of symptomatic CAUTIs in patients with >2 days of catheterization (in line with current standards), the weighted average reduction of infection was 35%. In certain studies a much larger reduction, of up to 70%, was observed. In addition to that use of  Bactriguard coated catheter demonstration shown decreased bacterial adhesion ,which in turn prevents biofilm formation and subsequent infection.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • •undergone Urethro plasty surgery and -willing to participate -available at the time of Data collection period -patient requires long term indwelling urinary catheterization minimum 28 days.

排除标准

  • •catheterized through Suprapubical puncture site -long term critically ill & admitted in ICU setting.
  • •immunoCompromised Patients – HIV & receiving Immuno compromised Drugs.

结局指标

主要结局

Rates of post-op UTI

时间窗: 3rd day and 28th day after the catheter insertion.

次要结局

未报告次要终点

研究者

发起方
ICMR
申办方类型
Government medical college

研究点 (1)

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