The Impact Of A Catheter Coating On Clinical Bacteriuria
Bacteriuria
About this trial
This is an interventional prevention trial for Bacteriuria
Eligibility Criteria
Inclusion Criteria:
- Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
- Patients aged 18+ years will be eligible for the study.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion Criteria:
- Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
- Pregnant or Breastfeeding.
- Patients with a potentially immunocompromised conditions (HIV)
- Has a known silicone allergy or sensitivity
- Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
- Any medication deemed by the Investigator to potentially interfere with the study treatment
- Participation in any other clinical study.
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
Sites / Locations
- Stoke Mandeville HospitalRecruiting
- Addenbrookes HospitalRecruiting
- Royal National Orthopaedic HospitalRecruiting
- Norfolk & Norwich University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Camstent Coated Catheter
Standard Care
The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked
Foley catheter, uncoated