Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections? (SHARKLET)

Jahn Ferenc South Pest Teaching Hospital

Status and phase

Completed

Phase 1

Conditions

Catheter Associated Urinary Tract Infections

Treatments

Device: Sharklet Catheter insertion

Device: Silicone Foley Catheter insertion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02835456

RCSFC028514

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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