Status:
TERMINATED
Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
United States Department of Defense
Conditions:
Urinary Tract Infection
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the study Foley catheter with its patterned external surface can delay the time to the onset of urinary tract infection in spinal cord injury patients who ...
Detailed Description
Roughly half of the two million nosocomial infections that occur each year are associated with the use of a medical device. Approximately 30 million urinary catheters are inserted each year into the b...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Veteran
- Hospitalized in one of the two participating Spinal Cord Injury Units
- Require a size 14, 16, or 18 French catheter
- Sign and date the written informed consent document acknowledging his/her desire to participate in the study, or if unable to sign due to spinal cord injury give verbal consent in front of two impartial witnesses who sign and date the informed consent document in the presence of the participant
- Be able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
- Require insertion or exchange of a Foley catheter for no longer than 15 days.
- Exclusion Criteria
- Unable to provide informed consent
- Has a current symptomatic urinary tract infection
- Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter insertion
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
- Has periurethral inflammation or infection
- Has a known urethral anatomical anomaly which makes catheterization difficult
- Has a known silicone allergy or sensitivity
- Cannot accommodate a size 14,16 or 18 French Foley catheter.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02198833
Start Date
September 1 2014
End Date
July 1 2015
Last Update
April 7 2017
Active Locations (2)
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1
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
2
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030