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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101371
• Other study ID #: 16-1096
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: March 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Infection
• Catheter-Related Infections
• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Catheter insertion with Povidone Iodine
The catheter will be treated with Povidone Iodine prior to insertion.

Procedure:
• Standard of care catheter insertion
Catheter inserted right out of package.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)