Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Primary Purpose
Urinary Tract Infections, Catheter Infection, Catheter-Related Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Catheter insertion with Povidone Iodine
Standard of care catheter insertion
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections
Eligibility Criteria
Inclusion Criteria:
- women 18-89 years of age
- admitted for surgery lasting >1 hour and requiring urinary catheter,
- have normal urine analysis within 24 hours pre-surgery, and
- able to provide informed consent.
Exclusion Criteria:
- currently on dialysis,
- chronic urinary infection,
- hyperthyroidism,
- current infection,
- a history of allergy or sensitivity to iodine.
- women who are pregnant or breast feeding
- men due to their lower incidence of UTIs compared to the female population.
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care catheter insertion
Aseptic protocol for catheter insertion
Arm Description
Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
Outcomes
Primary Outcome Measures
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
Secondary Outcome Measures
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.
Average Patient Satisfaction
Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.
Full Information
NCT ID
NCT03101371
First Posted
March 30, 2017
Last Updated
March 6, 2020
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03101371
Brief Title
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Official Title
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Catheter Infection, Catheter-Related Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or
Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care catheter insertion
Arm Type
Active Comparator
Arm Description
Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Arm Title
Aseptic protocol for catheter insertion
Arm Type
Experimental
Arm Description
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
Intervention Type
Drug
Intervention Name(s)
Catheter insertion with Povidone Iodine
Other Intervention Name(s)
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter
Intervention Description
The catheter will be treated with Povidone Iodine prior to insertion.
Intervention Type
Procedure
Intervention Name(s)
Standard of care catheter insertion
Intervention Description
Catheter inserted right out of package.
Primary Outcome Measure Information:
Title
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Description
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
Time Frame
Within 14 +/- 2 days post-surgery
Secondary Outcome Measure Information:
Title
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Description
Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.
Time Frame
Day 14 (+/- 2 days)
Title
Average Patient Satisfaction
Description
Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.
Time Frame
Day14 (+/- 2 days)
Title
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Description
Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.
Time Frame
14 days (+/- 2 days) from surgery
Title
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Description
Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.
Time Frame
Day 1 post op
Title
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Description
Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.
Time Frame
Day 14 (+/- 2 days)
Title
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Description
Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.
Time Frame
Day 14 (+/- 2 days)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women 18-89 years of age
admitted for surgery lasting >1 hour and requiring urinary catheter,
have normal urine analysis within 24 hours pre-surgery, and
able to provide informed consent.
Exclusion Criteria:
currently on dialysis,
chronic urinary infection,
hyperthyroidism,
current infection,
a history of allergy or sensitivity to iodine.
women who are pregnant or breast feeding
men due to their lower incidence of UTIs compared to the female population.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saketh Guntupalli, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
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