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

September 12, 2016 updated by: Medline Industries

A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Non-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). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

756

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 urinary Foley catheters.

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary tract infection rates
Time Frame: 3-9 months based on size of ICU and catheter usage
Infection rate/1000 catheter days.
3-9 months based on size of ICU and catheter usage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter use
Time Frame: Catheter days
Number of days catheters used.
Catheter days
Infection Costs
Time Frame: Duration of infection
Catheter related charges for infections
Duration of infection

Collaborators and Investigators

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

Sponsor

Medline Industries

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

May 1, 2014

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

March 27, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MII-001

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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