Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters
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|ClinicalTrials.gov Identifier: NCT02915692|
Recruitment Status : Terminated (Withdrawn funding)
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
|Condition or disease||Intervention/treatment|
|Surgery||Device: ERASE Silver Coated Foley Catheter Device: Comparator Silver Coated Catheter|
|Study Type :||Observational|
|Actual Enrollment :||753 participants|
|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|
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
- 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.
- 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..
- 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.
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
|United States, Georgia|
|Oconnee Regional Medical Center|
|Milledgenville, Georgia, United States, 31061|
|Principal Investigator:||S T Symeonides, MD||Parish Medical Center|