The Impact Of A Catheter Coating On Clinical Bacteriuria
NCT ID: NCT04461262
Last Updated: 2022-12-28
Study Results
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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UNKNOWN
NA
272 participants
INTERVENTIONAL
2021-04-27
2024-10-31
Brief Summary
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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 randomized to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Camstent Coated Catheter
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
Camstent Coated Catheter
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
Standard Care
Foley catheter, uncoated
Standard Care
Uncoated Foley catheter
Interventions
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Camstent Coated Catheter
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
Standard Care
Uncoated Foley catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients aged 18+ years will be eligible for the study.
3. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion Criteria
2. Pregnant or Breastfeeding.
3. Patients with a potentially immunocompromised conditions (HIV)
4. Has a known silicone allergy or sensitivity
5. Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
6. Any medication deemed by the Investigator to potentially interfere with the study treatment
7. Participation in any other clinical study.
8. Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
18 Years
ALL
No
Sponsors
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Camstent Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Prital Patel
Role: STUDY_DIRECTOR
Camstent Ltd.
Locations
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Stoke Mandeville Hospital
Buckingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal National Orthopaedic Hospital
London, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Countries
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Central Contacts
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Related Links
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Camstent
Other Identifiers
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Cam-Cath-001
Identifier Type: -
Identifier Source: org_study_id