Urinary Catheter, Urinary Tract Infections
Conditions
Keywords
Infection, Urinary Catheter, Sharklet
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.
Interventions
DEVICERadiance™ Clear Sharklet® Silicone Foley Catheter
DEVICESilicone Foley Catheter
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients are not told which catheter is inserted at which time point until after they exit the study.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL) | 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 | 12 weeks | Determine number of symptomatic UTIs between the 2 groups as determined by urine culture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Crustation | 12 weeks | Incidence of catheter obstruction/encrustation requiring removal |
| Incidence of Discomfort | 12 weeks | Incidence of significant discomfort/pain requiring removal |
| Delay to symptomatic CA-SUTI | 12 weeks | Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI) |
| Surface analysis of the amount of encrustation | 12 weeks | Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation |
| Surface analysis of the biofilm formation | 12 weeks | Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation |
| Surface analysis of the type of bacteria found on each catheter | 12 weeks | Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization |
| Incidence of bacteria | 12 weeks | Incidence of bacteremia following CA-SUTI |
Countries
Canada
Contacts
Primary ContactOlga Arsovska
Outcome results
None listed