Urinary Tract Infections
Conditions
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
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; 1. to evaluate the catheter's on-label performance in customary clinical use. 2. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.
Interventions
DEVICECamstent 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.
DEVICEStandard Care
Bard Catheter
Sponsors
Camstent Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care. 2. Patients aged 18-85 years will be eligible for the study. 3. Able to give informed consent.
Exclusion criteria
1. Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection. 2. Pregnant patients. 3. Patients with a potentially immunocompromised condition (steroids, HIV) 4. Patients who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed