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Sharklet Catheter Study

Primary Purpose

Urinary Catheter, Urinary Tract Infections

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Radiance™ Clear Sharklet® Silicone Foley Catheter
Silicone Foley Catheter
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Catheter focused on measuring Infection, Urinary Catheter, Sharklet

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Stone Centre, VGH/UBCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Sharklet Catheter for 2 weeks first

Group B: Sharklet Catheter for 4 weeks first

Arm Description

Arm A will have catheters inserted according to the schedule below: Sharklet catheter inserted for 2 weeks Standard catheter inserted for 2 weeks Sharklet catheter inserted for 4 weeks Standard catheter inserted for 4 weeks

Arm B will have catheters inserted according to the schedule below: Sharklet catheter inserted for 4 weeks Standard catheter inserted for 4 weeks Sharklet catheter inserted for 2 weeks Standard catheter inserted for 2 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Delay to symptomatic CA-SUTI
Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
Incidence of bacteria
Incidence of bacteremia following CA-SUTI
Incidence of Crustation
Incidence of catheter obstruction/encrustation requiring removal
Incidence of Discomfort
Incidence of significant discomfort/pain requiring removal
Surface analysis of the type of bacteria found on each catheter
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
Surface analysis of the amount of encrustation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
Surface analysis of the biofilm formation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation

Full Information

First Posted
January 20, 2016
Last Updated
April 4, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02669342
Brief Title
Sharklet Catheter Study
Official Title
Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Catheter, Urinary Tract Infections
Keywords
Infection, Urinary Catheter, Sharklet

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients are not told which catheter is inserted at which time point until after they exit the study.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Sharklet Catheter for 2 weeks first
Arm Type
Active Comparator
Arm Description
Arm A will have catheters inserted according to the schedule below: Sharklet catheter inserted for 2 weeks Standard catheter inserted for 2 weeks Sharklet catheter inserted for 4 weeks Standard catheter inserted for 4 weeks
Arm Title
Group B: Sharklet Catheter for 4 weeks first
Arm Type
Active Comparator
Arm Description
Arm B will have catheters inserted according to the schedule below: Sharklet catheter inserted for 4 weeks Standard catheter inserted for 4 weeks Sharklet catheter inserted for 2 weeks Standard catheter inserted for 2 weeks
Intervention Type
Device
Intervention Name(s)
Radiance™ Clear Sharklet® Silicone Foley Catheter
Intervention Type
Device
Intervention Name(s)
Silicone Foley Catheter
Other Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Description
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Time Frame
12 weeks
Title
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
Description
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Delay to symptomatic CA-SUTI
Description
Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
Time Frame
12 weeks
Title
Incidence of bacteria
Description
Incidence of bacteremia following CA-SUTI
Time Frame
12 weeks
Title
Incidence of Crustation
Description
Incidence of catheter obstruction/encrustation requiring removal
Time Frame
12 weeks
Title
Incidence of Discomfort
Description
Incidence of significant discomfort/pain requiring removal
Time Frame
12 weeks
Title
Surface analysis of the type of bacteria found on each catheter
Description
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
Time Frame
12 weeks
Title
Surface analysis of the amount of encrustation
Description
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
Time Frame
12 weeks
Title
Surface analysis of the biofilm formation
Description
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Arsovska
Phone
604-875-4111
Ext
62421
Email
olga.arsovska@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Lange, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Stone Centre, VGH/UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Arsovska
Phone
604-875-4111
Ext
62421
Email
olga.arsovska@ubc.ca
First Name & Middle Initial & Last Name & Degree
Dirk Lange, PhD
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
First Name & Middle Initial & Last Name & Degree
Mark Nigro, MD
First Name & Middle Initial & Last Name & Degree
Alex Kavanagh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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