NCT05719753CompletedNot Applicable
A Pilot Study to Characterise the Effectiveness of a Bacteriophobic Coating in Preventing
Camstent Ltd.2 sites in 1 country50 target enrollmentStarted: September 15, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (2)
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