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

September 23, 2016 updated by: Medline Industries

A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Silver Coated Foley Catheters Verse Silver Coated Foley Catheters

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

753

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Milledgenville, Georgia, United States, 31061
        • Oconnee Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects requiring Foley catheters

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infection rates
Time Frame: 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.
2 days on average or until hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter use
Time Frame: 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 days on average or until hospital discharge
Catheter Associated Urinary Track Infection Costs
Time Frame: 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.
Post Infection costs incurred from insertion of catheter to hospital discharge (<30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MII-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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