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Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters

Sponsor
Medline Industries (Industry)
Overall Status
Terminated
CT.gov ID
NCT02101762
Collaborator
(none)
756
Enrollment
28.1
Duration (Months)

Study Details

Study Description

Brief Summary

The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    756 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Non-Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
    Study Start Date :
    May 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Sep 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Silver Coated Catheters

    Subjects that had previously received silver coated Foley catheters.
    ERASE CAUTI Non-Silver Coated Catheters

    Subjects that received non-silver catheters from an ERASE CAUTI tray.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Urinary tract infection rates [3-9 months based on size of ICU and catheter usage]

      Infection rate/1000 catheter days.

    Secondary Outcome Measures

    1. Catheter use [Catheter days]

      Number of days catheters used.

    2. Infection Costs [Duration of infection]

      Catheter related charges for infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • At least 18 years of age

    • Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter

    Exclusion Criteria:

    • UTI present upon current hospital admission

    • Burn patients, transplant patients, or immune-compromised patients.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medline Industries

    Investigators

    • Study Director: Ed Drower, MS, Medline Industries

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medline Industries
    ClinicalTrials.gov Identifier:
    NCT02101762
    Other Study ID Numbers:
    • MII-001
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    Sep 13, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Medline Industries
    Foley
    Catheters
    CAUTI
    ERASE CAUTI

    Study Results

    No Results Posted as of Sep 13, 2016