Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Conditions
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Urinary Tract Infections, Catheter Infection, Catheter-Related Infections

Intervention / Treatment
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* Drug: Catheter insertion with Povidone Iodine
* Procedure: Standard of care catheter insertion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care catheter insertion<br>Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. | Procedure: Standard of care catheter insertion<br>* Catheter inserted right out of package.<br>|
| Experimental: Aseptic protocol for catheter insertion<br>Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter | Drug: Catheter insertion with Povidone Iodine<br>* The catheter will be treated with Povidone Iodine prior to insertion.<br>* Other names: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 14 +/- 2 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 14 (+/- 2 days) | 
| 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. | Day14 (+/- 2 days) | 
| 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. | 14 days (+/- 2 days) from surgery | 
| 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. | Day 1 post op | 
| 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. | Day 14 (+/- 2 days) | 
| 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. | Day 14 (+/- 2 days) |