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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02915692
• Other study ID #: MII-002
• Status: Terminated
• Phase: N/A
• First received: February 9, 2012
• Last updated: September 23, 2016
• Start date: October 2012
• 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). Improvements in the catheter insertion procedure using the ERASE CAUTI Tray system may help to lower these infection rates.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 753
• 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 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: Retrospective

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Oconnee Regional Medical Center	Milledgenville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary tract infection rates	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	Yes
Secondary	Catheter use	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	No
Secondary	Catheter Associated Urinary Track Infection Costs	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)	No