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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Jahn Ferenc South Pest Teaching Hospital
Budapest, Hungary
Catheter 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
Incidence of bacteremia
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., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization
Time frame: 12 weeks
Surface analysis of the amount of encrustation
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation
Time frame: 12 weeks
Surface analysis of the biofilm formation
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Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation
Time frame: 12 weeks