The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

Urinary Tract Infections Clinical Trial

— PRO033CSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719753
• Other study ID #: 18057
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2020
• Source: Camstent Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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.
• Standard Care
Bard Catheter

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Camstent Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	catheter blockage	catheter blockage	1 year
Secondary	catheter associated infection	catheter associated infection	1 year
Secondary	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