Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
研究概览
简要总结
The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.
详细描述
The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires a chronic indwelling Foley catheter for at least 3 days.
- •Catheters will not remain indwelling greater than 30 days at a time
- •Patient is more than 18 years of age
- •Patient is able to give informed consent
- •Patient is able to attend follow-up sessions
排除标准
- •Patient is less than 18 years of age
- •Patient is pregnant
- •Patient with a known allergy to silicone
- •Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
- •Patient unable to accommodate the catheter
- •Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.
- •Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
- •Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
- •Patient is unable to feel and/or communicate their symptoms
- •Informed consent is unable to be obtained
- •Patient is unable or unwilling to comply with the study follow-up schedule
- •Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
- •Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study
研究组 & 干预措施
Group A: Sharklet Catheter
Patient requiring indwelling urinary catheter will be randomised into Group A or Group B
干预措施: Sharklet Catheter insertion (Device)
Group B: Silicone Foley Catheter
Patient requiring indwelling urinary catheter will be randomised into Group A or Group B
干预措施: Silicone Foley Catheter insertion (Device)
结局指标
主要结局
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
时间窗: 12 weeks
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture.
时间窗: 12 weeks
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
次要结局
- Incidence of bacteremia(12 weeks)
- Incidence of Crustation(12 weeks)
- Incidence of Discomfort(12 weeks)
- Surface analysis of the type of bacteria found on each catheter(12 weeks)
- Surface analysis of the amount of encrustation(12 weeks)
- Surface analysis of the biofilm formation(12 weeks)
研究者
Prof. Peter Tenke
Director, Department of Urology
Jahn Ferenc South Pest Teaching Hospital