Sharklet Catheter Study

Urinary Tract Infections Clinical Trial

Official title:

Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669342
• Other study ID #: H15-03435
• Status: Recruiting
• Phase: Phase 1
• First received: January 20, 2016
• Last updated: April 4, 2017
• Start date: August 2016
• Est. completion date: February 2019

Study information

• Verified date: April 2017
• Source: University of British Columbia
• Contact: Olga Arsovska
• Phone: 604-875-4111
• Email: olga.arsovska[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Catheter
• Urinary Tract Infections

Intervention

Device:
• Radiance™ Clear Sharklet® Silicone Foley Catheter

• Silicone Foley Catheter

Locations

Country	Name	City	State
Canada	The Stone Centre, VGH/UBC	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Delay to symptomatic CA-SUTI	Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)	12 weeks
Secondary	Incidence of bacteria	Incidence of bacteremia following CA-SUTI	12 weeks
Secondary	Incidence of Crustation	Incidence of catheter obstruction/encrustation requiring removal	12 weeks
Secondary	Incidence of Discomfort	Incidence of significant discomfort/pain requiring removal	12 weeks
Secondary	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	12 weeks
Secondary	Surface analysis of the amount of encrustation	Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation	12 weeks
Secondary	Surface analysis of the biofilm formation	Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation	12 weeks