The Effectiveness of a Bacteriophobic Coating on Urinary Catheters (PRO033CSP)

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Device: Standard Care; Device: Camstent Coated Catheter

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Standard of Care; Bard Catheter	Device: Standard Care; Bard Catheter
EXPERIMENTAL: 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: 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.

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

Collaborators and Investigators

• Sponsor: Camstent Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2020
• Primary Completion (ACTUAL): September 20, 2021
• Study Completion (ACTUAL): December 20, 2021

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: 18057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No