NCT05719753

The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Camstent Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
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.
DEVICE	Standard Care	Bard Catheter

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-09-20
• Completion: 2021-12-20
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: United Kingdom