Clinical trial NCT03101371: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Catheter Infection
Catheter-Related Infections
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:

1. Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or
2. Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
timeFrame: Within 14 +/- 2 days post-surgery
Secondary outcomes:
measure: Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
timeFrame: Day 14 (+/- 2 days)
measure: Average Patient Satisfaction
timeFrame: Day14 (+/- 2 days)
measure: Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
timeFrame: 14 days (+/- 2 days) from surgery
measure: Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
timeFrame: Day 1 post op
measure: Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
timeFrame: Day 14 (+/- 2 days)
measure: Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
timeFrame: Day 14 (+/- 2 days)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Saketh Guntupalli, MD
role: PRINCIPAL_INVESTIGATOR
References: