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Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

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ClinicalTrials.gov Identifier: NCT02658903
Recruitment Status : Unknown
Verified January 2016 by Oxys Medical AG.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Oxys Medical AG

Study Description
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Brief Summary:
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

Condition or disease Intervention/treatment Phase
Urinary Infections Device: Oxys Catheter Device: Covidien Mona-Therm Foley catheter Phase 1

Detailed Description:

This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.

The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Study arm with Oxys-Cathter
The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.
 Device: Oxys Catheter
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
Control-arm with commercial catheter
The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
 Device: Covidien Mona-Therm Foley catheter
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.


Outcome Measures
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Primary Outcome Measures :
  1. Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Significant bacteriuria assessed by weekly bacterial cultures. [ Time Frame: every week during 4 weeks ]
  2. Clinically symptomatic catheter associated lower urinary infections. [ Time Frame: 4 weeks ]
  3. occurence of adverse events [ Time Frame: within 4 weeks ]
    safety endpoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.

Exclusion Criteria:

  • Need for antibiotic treatment for any infections
  • Urological intervention or need for catheter change within study duration of 4 weeks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658903


Contacts
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Contact: Christoph Scharf, MD ++41763322969 christoph.scharf@gmail.com
Contact: Christine Tivig, MD +41 787358855 ki.tivig@gmail.com

Locations
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Switzerland
University Hospital Balgrist Recruiting
Zurich, Switzerland, 8008
Contact: Thomas Kessler, Prof., MD    0041 44 386 11 11    Thomas.Kessler@balgrist.ch   
Contact: Ulrich Menert, MD    0041 44 386 56 68    Ulrich.Mehnert@balgrist.ch   
Sponsors and Collaborators
Oxys Medical AG
Investigators
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Principal Investigator: Thomas Kessler, MD Universitätsklinik Balgrist Zürich
More Information
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Responsible Party: Oxys Medical AG
ClinicalTrials.gov Identifier: NCT02658903    
Other Study ID Numbers: Oxys-01
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Oxys Medical AG:
Foley
Infection
Hospital acquired
catheter associated
urinary
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases