Clinical trial NCT02669342: Sharklet Catheter Study
Official title: Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Urinary Catheter
Urinary Tract Infections
Keywords: Infection
Urinary Catheter
Sharklet
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
timeFrame: 12 weeks
measure: Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
timeFrame: 12 weeks
Secondary outcomes:
measure: Delay to symptomatic CA-SUTI
timeFrame: 12 weeks
measure: Incidence of bacteria
timeFrame: 12 weeks
measure: Incidence of Crustation
timeFrame: 12 weeks
measure: Incidence of Discomfort
timeFrame: 12 weeks
measure: Surface analysis of the type of bacteria found on each catheter
timeFrame: 12 weeks
measure: Surface analysis of the amount of encrustation
timeFrame: 12 weeks
measure: Surface analysis of the biofilm formation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Stone Centre, VGH/UBC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Dirk Lange, PhD
role: PRINCIPAL_INVESTIGATOR
References: