Have you or your loved ones been diagnosed with catheter infection?

You may be eligible to participate in a catheter infection clinical trial.

Have you or your loved ones been diagnosed with catheter infection? You may be eligible to participate in a catheter infection clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Catheter Infection Clinical Trial in Aurora CO

NCT03101371 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with catheter infection?

You may be eligible to participate in a catheter infection clinical trial.

Have you or your loved ones been diagnosed with catheter infection? You may be eligible to participate in a catheter infection clinical trial.

Completed

Female

18 - 89

Years old

This study has recruited 99 Participants

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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Details for the study

Brief Title

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

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.

Treatments and/or Procedures

Catheter insertion with povidone iodine

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

Standard of care catheter insertion

Catheter inserted right out of package.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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 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)

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)

Study 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.