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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Sharklet Catheter for 2 weeks first | Active Comparator | Arm A will have catheters inserted according to the schedule below:
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| Group B: Sharklet Catheter for 4 weeks first | Active Comparator | Arm B will have catheters inserted according to the schedule below:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiance™ Clear Sharklet® Silicone Foley Catheter | Device |
| ||
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Arsovska | Contact | 604-875-4111 | 62421 | olga.arsovska@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dirk Lange, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Stone Centre, VGH/UBC | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 5, 2018 | |
| Reset | Sep 19, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 5, 2018 | Sep 19, 2018 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Patients are not told which catheter is inserted at which time point until after they exit the study.
| Silicone Foley Catheter |
| Device |
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| 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 |
| D052801 | Male Urogenital Diseases |