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Completed

NCT Number: NCT03101371

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

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.

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Key information

Conditions

Urinary Tract Infections Catheter Infection Catheter-Related Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Catheter insertion with Povidone Iodine

Drug

The catheter will be treated with Povidone Iodine prior to insertion.

Other names: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter

Standard of care catheter insertion

Procedure

Catheter inserted right out of package.

Primary outcomes

  1. 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

  1. Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation

    Time frame: 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.

  2. Average Patient Satisfaction

    Time frame: 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.

  3. Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)

    Time frame: 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.

  4. Number of Participants With Closed Drainage System Disrupted During Placement of Catheter

    Time frame: 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.

  5. Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason

    Time frame: 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.

  6. Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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