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

Phase 2

Completed

Conditions: Urinary Tract Infections
Catheter Infection
Catheter-Related Infections

Interventions: Procedure: Standard of care catheter insertion
Drug: Catheter insertion with Povidone Iodine

Registration Number: NCT03101371

Lead Sponsor: University of Colorado, Denver

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 99

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care catheter insertion	Standard of care catheter insertion	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Aseptic protocol for catheter insertion	Catheter insertion with Povidone Iodine	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)	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 Outcome Measures

Name	Time	Method
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason	Day 14 (+/- 2 days)	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.
Average Patient Satisfaction	Day14 (+/- 2 days)	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.
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)	14 days (+/- 2 days) from surgery	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.
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery	Day 14 (+/- 2 days)	Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation	Day 14 (+/- 2 days)	Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter	Day 1 post op	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.