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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02101762
• Other study ID #: MII-001
• Status: Terminated
• Phase: N/A
• First received: February 9, 2012
• Last updated: September 12, 2016
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 756
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intensive Care Units
• Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary tract infection rates	Infection rate/1000 catheter days.	3-9 months based on size of ICU and catheter usage	Yes
Secondary	Catheter use	Number of days catheters used.	Catheter days	No
Secondary	Infection Costs	Catheter related charges for infections	Duration of infection	No