Back to resultsThe Effectiveness of a Bacteriophobic Coating on Urinary Catheters (PRO033CSP)
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Camstent Coated Catheter
Standard Care
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections
Eligibility Criteria
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
Sites / Locations
- University of Nottingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard of Care
Camstent Coated Catheter
Arm Description
Bard 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
catheter blockage
catheter blockage
catheter associated infection
catheter associated infection
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05719753
Brief Title
The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
Acronym
PRO033CSP
Official Title
A Pilot Study to Characterise the Effectiveness of a Bacteriophobic Coating in Preventing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camstent Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Bard Catheter
Arm Title
Camstent Coated Catheter
Arm Type
Experimental
Arm Description
The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.
Intervention Type
Device
Intervention Name(s)
Camstent Coated Catheter
Intervention Description
The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.
Intervention Type
Device
Intervention Name(s)
Standard Care
Intervention Description
Bard Catheter
Primary Outcome Measure Information:
Title
An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.
Description
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
Secondary Outcome Measure Information:
Title
catheter blockage
Description
catheter blockage
Time Frame
1 year
Title
catheter associated infection
Description
catheter associated infection
Time Frame
1 year
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
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