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To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization
The purpose of the study is to provide pilot information on the characteristics of the biofilm formed on the coated catheter compared to a standard catheter. The two objectives are;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Placebo Comparator | Bard Catheter |
|
| Camstent Coated Catheter | Experimental | The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camstent Coated Catheter | Device | The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied. |
| Measure | Description | Time Frame |
|---|---|---|
| An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters. | An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| catheter blockage | catheter blockage | 1 year |
| catheter associated infection | catheter associated infection | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
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| 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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| Standard Care | Device | Bard Catheter |
|
| Ease of insertion and removal of the catheter since it creates a very smooth and slippery surface using the NHS staff standard clinical feedback form. | Ease of insertion and removal of the catheter since it creates a very smooth and slippery surface using the NHS staff standard clinical feedback form. | 1 year |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |