Catheter Associated Urinary Tract Infections Clinical Trial
— SHARKLETOfficial title:
Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
| Verified date | January 2017 |
| Source | Jahn Ferenc South Pest Teaching Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Jahn Ferenc South Pest Teaching Hospital | Budapest |
| Lead Sponsor | Collaborator |
|---|---|
| Jahn Ferenc South Pest Teaching Hospital | Cook Group Incorporated |
Hungary,
| 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 | Incidence of bacteremia | 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., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization | 12 weeks | |
| Secondary | Surface analysis of the amount of encrustation | Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation | 12 weeks | |
| Secondary | Surface analysis of the biofilm formation | Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation | 12 weeks |