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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Catheter Infection; Catheter-Related Infections
• Intervention / Treatment: Procedure: Standard of care catheter insertion; Drug: Catheter insertion with Povidone Iodine

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. women 18-89 years of age
2. admitted for surgery lasting >1 hour and requiring urinary catheter,
3. have normal urine analysis within 24 hours pre-surgery, and
4. able to provide informed consent.

Exclusion Criteria:

1. currently on dialysis,
2. chronic urinary infection,
3. hyperthyroidism,
4. current infection,
5. a history of allergy or sensitivity to iodine.
6. women who are pregnant or breast feeding
7. men due to their lower incidence of UTIs compared to the female population.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Saketh Guntupalli, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Plasma Substitutes; Blood Substitutes; Iodine; Povidone-Iodine; Povidone
• Other Study ID Numbers: 16-1096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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