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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
32
The Stone Centre, VGH/UBC
Vancouver, British Columbia, Canada
RECRUITINGCatheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Time frame: 12 weeks
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
Time frame: 12 weeks
Delay to symptomatic CA-SUTI
Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
Time frame: 12 weeks
Incidence of bacteria
Incidence of bacteremia following CA-SUTI
Time frame: 12 weeks
Incidence of Crustation
Incidence of catheter obstruction/encrustation requiring removal
Time frame: 12 weeks
Incidence of Discomfort
Incidence of significant discomfort/pain requiring removal
Time frame: 12 weeks
Surface analysis of the type of bacteria found on each catheter
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
Time frame: 12 weeks
Surface analysis of the amount of encrustation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
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Time frame: 12 weeks
Surface analysis of the biofilm formation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation
Time frame: 12 weeks