A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter. Each participant will take part in the trial from the time the participant signs the informed consent form (ICF). After the screening visit, the participants will be allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent. During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
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.
Uncoated Foley Catheter
The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters
Time frame: 1 Year
• Patient Reported Outcomes (PRO)
Time frame: 1 Year
• Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Time frame: 1 Year
• Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Time frame: 1 Year
• Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls
Time frame: 1 Year
• Reduction in Biofilm
Time frame: 1 Year
• Reduction in site infection
Time frame: 1 Year
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