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OpenTrials
Completed

NCT Number: NCT02835456

Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jahn Ferenc South Pest Teaching Hospital

Budapest, 1204, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sharklet Catheter insertion

Device

Silicone Foley Catheter insertion

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jahn Ferenc South Pest Teaching Hospital

Other Gov

Collaborators

  • Cook Group Incorporated

Registry information

Acronym: SHARKLET

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2016
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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