Skip to main content
Clinical Trials/NCT03101371
NCT03101371
Completed
Phase 2

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

University of Colorado, Denver1 site in 1 country99 target enrollmentOctober 10, 2017

Overview

Phase
Phase 2
Intervention
Standard of care catheter insertion
Conditions
Urinary Tract Infections
Sponsor
University of Colorado, Denver
Enrollment
99
Locations
1
Primary Endpoint
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2017
End Date
February 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Standard of care catheter insertion

Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.

Intervention: Standard of care catheter insertion

Aseptic protocol for catheter insertion

Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter

Intervention: Catheter insertion with Povidone Iodine

Outcomes

Primary Outcomes

Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)

Time Frame: Within 14 +/- 2 days post-surgery

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 Outcomes

  • Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason(Day 14 (+/- 2 days))
  • Average Patient Satisfaction(Day14 (+/- 2 days))
  • Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)(14 days (+/- 2 days) from surgery)
  • Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery(Day 14 (+/- 2 days))
  • Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation(Day 14 (+/- 2 days))
  • Number of Participants With Closed Drainage System Disrupted During Placement of Catheter(Day 1 post op)

Study Sites (1)

Loading locations...

Similar Trials