Sharklet Catheter Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Catheter, Urinary Tract Infections

Intervention / Treatment
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* Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
* Device: Silicone Foley Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Sharklet Catheter for 2 weeks first<br>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 | Device: Radiance™ Clear Sharklet® Silicone Foley Catheter<br> <br> Device: Silicone Foley Catheter<br> <br> * Other names: Standard of care;|
| Active Comparator: Group B: Sharklet Catheter for 4 weeks first<br>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 | Device: Radiance™ Clear Sharklet® Silicone Foley Catheter<br> <br> Device: Silicone Foley Catheter<br> <br> * Other names: Standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, Urinary Catheter, Sharklet