ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02915692
Recruitment Status : Terminated (Withdrawn funding)
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Surgery Device: ERASE Silver Coated Foley Catheter Device: Comparator Silver Coated Catheter

Study Type : Observational
Actual Enrollment : 753 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
Study Start Date : October 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Group/Cohort Intervention/treatment
ERASE Silver Coated Foley Catheters
Subjects given silver catheters from an ERASE CAUTI Tray.
Device: ERASE Silver Coated Foley Catheter
Foley catheter from ERASE CAUTI Kit will be administered as required.
Other Name: Silver coated Foley catheter

Comparator Silver Coated Catheter
Comparator silver urinary catheter
Device: Comparator Silver Coated Catheter
Foley catheter coated with silver
Other Name: Silver coated catheter




Primary Outcome Measures :
  1. Urinary tract infection rates [ Time Frame: 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 :
  1. Catheter use [ Time Frame: 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..

  2. Catheter Associated Urinary Track Infection Costs [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects requiring Foley catheters
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915692


Locations
United States, Georgia
Oconnee Regional Medical Center
Milledgenville, Georgia, United States, 31061
Sponsors and Collaborators
Medline Industries
Investigators
Principal Investigator: S T Symeonides, MD Parish Medical Center

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02915692     History of Changes
Other Study ID Numbers: MII-002
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medline Industries:
Foley
CAUTI
ERASE CAUTI