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Trial record 1 of 2 for:    sharklet
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Sharklet Catheter Study

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ClinicalTrials.gov Identifier: NCT02669342
Recruitment Status : Unknown
Verified April 2017 by Dirk Lange, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dirk Lange, University of British Columbia

Study Description
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Brief Summary:
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Condition or disease Intervention/treatment Phase
Urinary Catheter Urinary Tract Infections Device: Radiance™ Clear Sharklet® Silicone Foley Catheter Device: Silicone Foley Catheter Phase 1

Detailed Description:
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patients are not told which catheter is inserted at which time point until after they exit the study.
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
Study Start Date : August 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A: Sharklet Catheter for 2 weeks first

Arm A will have catheters inserted according to the schedule below:

  1. Sharklet catheter inserted for 2 weeks
  2. Standard catheter inserted for 2 weeks
  3. Sharklet catheter inserted for 4 weeks
  4. Standard catheter inserted for 4 weeks
 Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
Device: Silicone Foley Catheter
Other Name: Standard of care
Active Comparator: Group B: Sharklet Catheter for 4 weeks first

Arm B will have catheters inserted according to the schedule below:

  1. Sharklet catheter inserted for 4 weeks
  2. Standard catheter inserted for 4 weeks
  3. Sharklet catheter inserted for 2 weeks
  4. Standard catheter inserted for 2 weeks
 Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
Device: Silicone Foley Catheter
Other Name: Standard of care


Outcome Measures
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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. Delay to symptomatic CA-SUTI [ Time Frame: 12 weeks ]
    Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)

  2. Incidence of bacteria [ Time Frame: 12 weeks ]
    Incidence of bacteremia following CA-SUTI

  3. Incidence of Crustation [ Time Frame: 12 weeks ]
    Incidence of catheter obstruction/encrustation requiring removal

  4. Incidence of Discomfort [ Time Frame: 12 weeks ]
    Incidence of significant discomfort/pain requiring removal

  5. Surface analysis of the type of bacteria found on each catheter [ Time Frame: 12 weeks ]
    Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization

  6. Surface analysis of the amount of encrustation [ Time Frame: 12 weeks ]
    Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation

  7. Surface analysis of the biofilm formation [ Time Frame: 12 weeks ]
    Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation


Eligibility Criteria
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Ages Eligible for Study:   19 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 14 days. Catheters will not remain indwelling greater than 30 days at a time
  • Patient is more than 19 years of age
  • Patient is able to give informed consent
  • Patient is able to attend follow-up sessions

Exclusion Criteria:

  • Patient is less than 19 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. Once the infection has been treated, the patient is eligible for study.
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669342


Contacts
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Contact: Olga Arsovska 604-875-4111 ext 62421 olga.arsovska@ubc.ca

Locations
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Canada, British Columbia
The Stone Centre, VGH/UBC Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska    604-875-4111 ext 62421    olga.arsovska@ubc.ca   
Principal Investigator: Dirk Lange, PhD         
Sub-Investigator: Ben Chew, MD         
Sub-Investigator: Mark Nigro, MD         
Sub-Investigator: Alex Kavanagh, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Dirk Lange, PhD University of British Columbia
More Information
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Responsible Party: Dirk Lange, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02669342    
Other Study ID Numbers: H15-03435
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dirk Lange, University of British Columbia:
Infection
Urinary Catheter
Sharklet
Additional relevant MeSH terms:
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Urinary Tract Infections
Infections
Urologic Diseases