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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Infections; Catheter-Related Infections; Catheter Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03101371

16-1096

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Standard of care catheter insertion

Active Comparator group

Description:

Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.

Treatment:

Procedure: Standard of care catheter insertion

Aseptic protocol for catheter insertion

Experimental group

Description:

Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter

Treatment:

Drug: Catheter insertion with Povidone Iodine