Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
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|ClinicalTrials.gov Identifier: NCT03101371|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections Catheter Infection Catheter-Related Infections||Drug: Catheter insertion with Povidone Iodine Procedure: Standard of care catheter insertion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients with normal UA pre-surgery will be randomized 1:1 to one of two arms prior to surgery:
|Masking:||None (Open Label)|
|Official Title:||Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Standard of care catheter insertion
Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Procedure: Standard of care catheter insertion
Catheter inserted right out of package.
Experimental: Aseptic protocol for catheter insertion
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
Drug: Catheter insertion with Povidone Iodine
The catheter will be treated with Povidone Iodine prior to insertion.
Other Name: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter
- Reduction in Urinary Tract Infections [ Time Frame: 14 +/- 2 days post-surgery ]Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Investigators plan to demonstrate that reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with UTIs and improve cost-effectiveness of care.
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): NCT03101371
|Contact: Dina Flink, PhDemail@example.com|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Dina Flink, PhD 303-724-8467 firstname.lastname@example.org|
|Principal Investigator: Saketh Guntupalli, MD|
|Principal Investigator:||Saketh Guntupalli, MD||University of Colorado, Denver|