Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
研究概览
简要总结
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
详细描述
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard 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
- Single (Participant)
盲法说明
Patients are not told which catheter is inserted at which time point until after they exit the study.
入排标准
- 年龄范围
- 19 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 14 days. Catheters will not remain indwelling greater than 30 days at a time
- •Patient is more than 19 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 19 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. Once the infection has been treated, the patient is eligible for study.
- •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
结局指标
主要结局
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.
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.
次要结局
- Delay to symptomatic CA-SUTI(12 weeks)
- Incidence of bacteria(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
Dirk Lange
Assistant Professor
University of British Columbia