NCT02101762

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2012

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

February 9, 2012

Last Update Submit

September 12, 2016

Conditions

SurgeryIntensive Care Units

Keywords

FoleyCathetersCAUTIERASE CAUTI

Outcome Measures

Primary Outcomes (1)

  • Change in Urinary tract infection rates

    Infection rate/1000 catheter days.

    3-9 months based on size of ICU and catheter usage

Secondary Outcomes (2)

  • Catheter use

    Catheter days

  • Infection Costs

    Duration of infection

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects requiring urinary Foley catheters.

You may qualify if:

  • At least 18 years of age
  • Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter

You may not qualify if:

  • UTI present upon current hospital admission
  • Burn patients, transplant patients, or immune-compromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ed Drower, MS

    Medline Industries

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

April 2, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share