The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

Study Overview
=================
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; to evaluate the catheter's on-label performance in customary clinical use. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.

Official Title
-----------------
A Pilot Study to Characterise the Effectiveness of a Bacteriophobic Coating in Preventing

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Device: Camstent Coated Catheter
* Device: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care. Patients aged 18-85 years will be eligible for the study. Able to give informed consent. Exclusion Criteria: Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection. Pregnant patients. Patients with a potentially immunocompromised condition (steroids, HIV) Patients who are unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of Care<br>Bard Catheter | Device: Standard Care<br>* Bard Catheter<br>|
| Experimental: Camstent Coated Catheter<br>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<br>* The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter blockage | catheter blockage | 1 year | 
| catheter associated infection | catheter associated infection | 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. | 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 |