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

• ClinicalTrials.gov Identifier: NCT02835456
• Recruitment Status: Completed
• First Posted: July 18, 2016
• Last Update Posted: January 4, 2017
• Sponsor: Jahn Ferenc South Pest Teaching Hospital
• Collaborator: Cook Group Incorporated
• Information provided by (Responsible Party): Prof. Peter Tenke, Jahn Ferenc South Pest Teaching Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Catheter Associated Urinary Tract Infections	Device: Sharklet Catheter insertion; Device: Silicone Foley Catheter insertion	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
• Study Start Date: August 2016
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL) [ Time Frame: 12 weeks ]
   Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
2. Number of symptomatic Urinary tract infections (UTIs) determined by urine culture. [ Time Frame: 12 weeks ]
   Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.

Secondary Outcome Measures :

1. Incidence of bacteremia [ Time Frame: 12 weeks ]
   Incidence of bacteremia following CA-SUTI
2. Incidence of Crustation [ Time Frame: 12 weeks ]
   Incidence of catheter obstruction/encrustation requiring removal
3. Incidence of Discomfort [ Time Frame: 12 weeks ]
   Incidence of significant discomfort/pain requiring removal
4. Surface analysis of the type of bacteria found on each catheter [ Time Frame: 12 weeks ]
   Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization
5. Surface analysis of the amount of encrustation [ Time Frame: 12 weeks ]
   Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation
6. Surface analysis of the biofilm formation [ Time Frame: 12 weeks ]
   Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Hungary

Jahn Ferenc South Pest Teaching Hospital

Budapest, Hungary, 1204

Sponsors and Collaborators

Jahn Ferenc South Pest Teaching Hospital

Cook Group Incorporated

More Information

• Responsible Party: Prof. Peter Tenke, Director, Department of Urology, Jahn Ferenc South Pest Teaching Hospital
• ClinicalTrials.gov Identifier: NCT02835456
• Other Study ID Numbers: RCSFC028514
• First Posted: July 18, 2016
• Last Update Posted: January 4, 2017
• Last Verified: January 2017

Keywords provided by Prof. Peter Tenke, Jahn Ferenc South Pest Teaching Hospital:

CAUTI; Biofilm; Urinary tract infections; micropattern; Catheter

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Disease Attributes; Pathologic Processes; Urologic Diseases