The Effectiveness of a Bacteriophobic Coating on Urinary Catheters (PRO033CSP)

Camstent

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Device: Standard Care; Device: Camstent Coated Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05719753

18057

Details and patient eligibility

About

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

Full 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;

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Standard of Care

Placebo Comparator group

Description:

Bard Catheter

Treatment:

Device: Standard Care

Camstent Coated Catheter

Experimental group

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.

Treatment:

Device: Camstent Coated Catheter