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OpenTrials
Completed

NCT Number: NCT05719753

The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

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

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camstent Coated Catheter

Device

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

Device

Bard Catheter

Primary outcomes

  1. An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.

    Time frame: 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 outcomes

  1. catheter blockage

    Time frame: 1 year

    catheter blockage

  2. catheter associated infection

    Time frame: 1 year

    catheter associated infection

  3. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Camstent Ltd.

Industry

Registry information

Official study title

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

Acronym: PRO033CSP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2023
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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