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| Name | Class |
|---|---|
| Cook Group Incorporated | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Sharklet Catheter | Active Comparator | Patient requiring indwelling urinary catheter will be randomised into Group A or Group B |
|
| Group B: Silicone Foley Catheter | Active Comparator | Patient requiring indwelling urinary catheter will be randomised into Group A or Group B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sharklet Catheter insertion | Device |
| ||
| Silicone Foley Catheter insertion |
| 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 |
|---|---|---|
| Incidence of bacteremia | Incidence of bacteremia following CA-SUTI | 12 weeks |
| Incidence of Crustation | Incidence of catheter obstruction/encrustation requiring removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jahn Ferenc South Pest Teaching Hospital | Budapest | 1204 | Hungary |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 12, 2017 | |
| Reset | Apr 21, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2017 | Apr 21, 2017 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Device |
|
| 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., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization | 12 weeks |
| Surface analysis of the amount of encrustation | Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation | 12 weeks |
| Surface analysis of the biofilm formation | Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation | 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |