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

NCT02915692 | Terminated

• 1 other identifier: MII-002
• Study Type: observational
• Target: 753
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Foley; CAUTI; ERASE CAUTI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Catheter use

  2 days on average or until hospital discharge

• Catheter Associated Urinary Track Infection Costs

  Post Infection costs incurred from insertion of catheter to hospital discharge (<30 days)

Study Arms (2)

ERASE Silver Coated Foley Catheters

Subjects given silver catheters from an ERASE CAUTI Tray.

Device: ERASE Silver Coated Foley Catheter

Comparator Silver Coated Catheter

Comparator silver urinary catheter

Device: Comparator Silver Coated Catheter

Interventions

ERASE Silver Coated Foley Catheter DEVICE

Foley catheter from ERASE CAUTI Kit will be administered as required.

Also known as: Silver coated Foley catheter

ERASE Silver Coated Foley Catheters

Comparator Silver Coated Catheter DEVICE

Foley catheter coated with silver

Also known as: Silver coated catheter

Comparator Silver Coated Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects requiring Foley catheters

You may qualify if:

• At least 18 years of age
• Received either silver coated Foley catheter or ERASE CAUTI silver coated catheter

You may not qualify if:

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

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Oconnee Regional Medical Center

Milledgenville, Georgia, 31061, United States

Location

Study Officials

• S T Symeonides, MD

  Parish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: September 27, 2016
• Study Start: October 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)