Phase 2
N=99
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Urinary Tract Infections · Catheter Infection · Catheter-Related Infections
Bottom Line
View on ClinicalTrials.gov: NCT03101371 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) — 7; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Catheter insertion with Povidone Iodine (Drug); Standard of care catheter insertion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) |
7; 6 | — |
| SECONDARY Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation |
38; 40; 7; 5 | — |
| SECONDARY Average Patient Satisfaction |
8.17; 8.6 | — |
| SECONDARY Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI) |
0; 1 | — |
| SECONDARY Number of Participants With Closed Drainage System Disrupted During Placement of Catheter |
42; 42 | — |
| SECONDARY Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason |
0; 1 | — |
| SECONDARY Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery |
36; 39; 5; 0; 12; 11 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03101371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.