The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Device: Standard Care; Device: Camstent Coated Catheter

• Registration Number: NCT05719753
• Lead Sponsor: Camstent Ltd.

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.

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-09-15
• Primary Completion: 2021-09-20
• Study Completion: 2021-12-20
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard Care	Bard Catheter
Camstent Coated Catheter	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom