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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgery

Intervention / Treatment
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* Device: ERASE Silver Coated Foley Catheter
* Device: Comparator Silver Coated Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERASE Silver Coated Foley Catheters<br>Subjects given silver catheters from an ERASE CAUTI Tray. | Device: ERASE Silver Coated Foley Catheter<br>* Foley catheter from ERASE CAUTI Kit will be administered as required.<br>* Other names: Silver coated Foley catheter;|
| Comparator Silver Coated Catheter<br>Comparator silver urinary catheter | Device: Comparator Silver Coated Catheter<br>* Foley catheter coated with silver<br>* Other names: Silver coated catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley, CAUTI, ERASE CAUTI