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

Terminated

• Conditions: Surgery
• Interventions: Device: Comparator Silver Coated Catheter; Device: ERASE Silver Coated Foley Catheter

• Registration Number: NCT02915692
• Lead Sponsor: Medline Industries

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-09
• Study Start: 2012-10
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted QC: 2016-09-23
• Last Update Submitted: 2016-09-23
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 753

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparator Silver Coated Catheter	Comparator Silver Coated Catheter	Comparator silver urinary catheter
ERASE Silver Coated Foley Catheters	ERASE Silver Coated Foley Catheter	Subjects given silver catheters from an ERASE CAUTI Tray.

Primary Outcome Measures

Name	Time	Method
Urinary tract infection rates	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.

Secondary Outcome Measures

Name	Time	Method
Catheter Associated Urinary Track Infection Costs	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.
Catheter use	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..

Trial Locations

Locations (1)

Oconnee Regional Medical Center; 🇺🇸 Milledgenville, Georgia, United States