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

Sponsor
Medline Industries (Industry)
Overall Status
Terminated
CT.gov ID
NCT02915692
Collaborator
(none)
753
1
47
16

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). Improvements in the catheter insertion procedure using the ERASE CAUTI Tray system may help to lower these infection rates.

Condition or Disease Intervention/Treatment Phase
  • Device: ERASE Silver Coated Foley Catheter
  • Device: Comparator Silver Coated Catheter

Study Design

Study Type:
Observational
Actual Enrollment :
753 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
ERASE Silver Coated Foley Catheters

Subjects given silver catheters from an ERASE CAUTI Tray.

Device: ERASE Silver Coated Foley Catheter
Foley catheter from ERASE CAUTI Kit will be administered as required.
Other Names:
  • Silver coated Foley catheter
  • Comparator Silver Coated Catheter

    Comparator silver urinary catheter

    Device: Comparator Silver Coated Catheter
    Foley catheter coated with silver
    Other Names:
  • Silver coated catheter
  • Outcome Measures

    Primary Outcome Measures

    1. Urinary tract infection rates [2 days on average or until hospital discharge]

      Infection rate/1000 catheter days based on days of use. As the number of days a catheter is used varies, the minimum expected time frame on average is 2 days. However, infections will be monitored during catheter use.

    Secondary Outcome Measures

    1. Catheter use [2 days on average or until hospital discharge]

      The average number of days a catheter is used is typically 2 days. However during the hospital stay, the time a catheter remains varies on medical need. The total daily use of each catheter will be tabulated after removal..

    2. Catheter Associated Urinary Track Infection Costs [Post Infection costs incurred from insertion of catheter to hospital discharge (<30 days)]

      Costs associated with urinary track Infections during the use of a catheter in the study will calculated from the time infection was identified until hospital discharge.

    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 silver coated catheter

    Exclusion Criteria:
    • UTI present upon current hospital admission

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oconnee Regional Medical Center Milledgenville Georgia United States 31061

    Sponsors and Collaborators

    • Medline Industries

    Investigators

    • Principal Investigator: S T Symeonides, MD, Parish Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medline Industries
    ClinicalTrials.gov Identifier:
    NCT02915692
    Other Study ID Numbers:
    • MII-002
    First Posted:
    Sep 27, 2016
    Last Update Posted:
    Sep 27, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Medline Industries

    Study Results

    No Results Posted as of Sep 27, 2016