The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

NCT ID: NCT05719753

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-12-20

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care

Bard Catheter

Group Type PLACEBO_COMPARATOR

Standard Care

Intervention Type DEVICE

Bard Catheter

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.

Group Type EXPERIMENTAL

Camstent Coated Catheter

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Standard Care

Bard Catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Camstent Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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18057

Identifier Type: -

Identifier Source: org_study_id

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