Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections? (SHARKLET)

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 Overview

• Status: Completed
• Conditions: Catheter Associated Urinary Tract Infections
• Intervention / Treatment: Device: Sharklet Catheter insertion; Device: Silicone Foley Catheter insertion

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc South Pest Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient requires a chronic indwelling Foley catheter for at least 3 days.
• Catheters will not remain indwelling greater than 30 days at a time
• Patient is more than 18 years of age
• Patient is able to give informed consent
• Patient is able to attend follow-up sessions

Exclusion Criteria:

• Patient is less than 18 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Sharklet Catheter; Patient requiring indwelling urinary catheter will be randomised into Group A or Group B	Device: Sharklet Catheter insertion
Active Comparator: Group B: Silicone Foley Catheter; Patient requiring indwelling urinary catheter will be randomised into Group A or Group B	Device: Silicone Foley Catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bacteremia	Incidence of bacteremia following CA-SUTI	12 weeks
Incidence of Crustation	Incidence of catheter obstruction/encrustation requiring removal	12 weeks
Incidence of Discomfort	Incidence of significant discomfort/pain requiring removal	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	12 weeks
Surface analysis of the amount of encrustation	Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation	12 weeks
Surface analysis of the biofilm formation	Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation	12 weeks

Collaborators and Investigators

• Sponsor: Jahn Ferenc South Pest Teaching Hospital
• Collaborators: Cook Group Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 1, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Biofilm; Catheter; Urinary tract infections; CAUTI; micropattern
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: RCSFC028514