Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Catheter Associated Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A: Sharklet Catheter

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Group Type ACTIVE_COMPARATOR

Sharklet Catheter insertion

Intervention Type DEVICE

Group B: Silicone Foley Catheter

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Group Type ACTIVE_COMPARATOR

Silicone Foley Catheter insertion

Intervention Type DEVICE

Interventions

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Sharklet Catheter insertion

Intervention Type DEVICE

Silicone Foley Catheter insertion

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No