Jahn Ferenc South Pest Teaching Hospital
Budapest, 1204, Hungary
NCT Number: NCT02835456
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Budapest, 1204, Hungary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 weeks
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Time frame: 12 weeks
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
Time frame: 12 weeks
Incidence of bacteremia following CA-SUTI
Time frame: 12 weeks
Incidence of catheter obstruction/encrustation requiring removal
Time frame: 12 weeks
Incidence of significant discomfort/pain requiring removal
Time frame: 12 weeks
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization
Time frame: 12 weeks
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation
Time frame: 12 weeks
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation
Jahn Ferenc South Pest Teaching Hospital
Other Gov
Acronym: SHARKLET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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