PRO033CSP: The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
Study Details
Study Description
Brief Summary
To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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;
-
to evaluate the catheter's on-label performance in customary clinical use.
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to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Standard of Care Bard Catheter |
Device: Standard Care
Bard Catheter
|
| Experimental: Camstent Coated Catheter The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied. |
Device: Camstent Coated Catheter
The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.
|
Outcome Measures
Primary Outcome Measures
- 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]
An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.
Secondary Outcome Measures
- catheter blockage [1 year]
catheter blockage
- catheter associated infection [1 year]
catheter associated infection
- 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]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care.
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Patients aged 18-85 years will be eligible for the study.
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Able to give informed consent.
Exclusion Criteria:
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Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
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Pregnant patients.
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Patients with a potentially immunocompromised condition (steroids, HIV)
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Patients who are unable to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nottingham | Nottingham | Nottinghamshire | United Kingdom | NG7 2UH |
Sponsors and Collaborators
- Camstent Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18057