The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
PRO033CSP
A Pilot Study to Characterise the Effectiveness of a Bacteriophobic Coating in Preventing
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedFirst Submitted
Initial submission to the registry
December 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedFebruary 9, 2023
August 1, 2020
1 year
December 27, 2022
January 30, 2023
Conditions
Outcome Measures
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.
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 Outcomes (3)
catheter blockage
1 year
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.
1 year
Study Arms (2)
Standard of Care
PLACEBO COMPARATORBard Catheter
Camstent Coated Catheter
EXPERIMENTALThe Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.
Interventions
The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Camstent Ltd.lead
Study Sites (1)
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2022
First Posted
February 9, 2023
Study Start
September 15, 2020
Primary Completion
September 20, 2021
Study Completion
December 20, 2021
Last Updated
February 9, 2023
Record last verified: 2020-08