Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection

Not Applicable

Terminated

• Conditions: Urinary Tract Infection
• Interventions: Biological: Urine Culture; Device: Foley Catheter Tip Culture; Device: Scanning Electron Microscopy; Procedure: Device Specific Adverse Event Assessment; Procedure: Foley Catheter Insertion

• Registration Number: NCT02198833
• Lead Sponsor: Baylor College of Medicine

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 are dependent on a Foley catheter for drainage of their urinary bladder.

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 bladder of over five million patients, and each catheterized patient is at risk of developing catheter-associated symptomatic urinary tract infection. About 95% of urinary tract infections are associated with the use of a urinary catheter. Not only is catheter associated urinary tract infection the most common nosocomial infection in general, but it is also the most common infectious reason for admission to the hospital among the population of 275 thousand Americans with spinal cord injury, which expands by approximately 12 thousand persons each year. Hospital-acquired infections boost today's healthcare costs by billions of dollars and healthcare providers are increasingly responsible for shouldering these costs.

Catheter-associated symptomatic urinary tract infection is usually caused by organisms that originate from the patient's own colonic and perineal flora, or the hands of healthcare personnel during catheter insertion and manipulation of the collection system. Microbial species predominantly migrate into the bladder extraluminally via the mucoid film that forms between the catheter surface and the urethra. Current approaches for preventing catheter-related infections include antimicrobial modification of the catheter surface. Although these antimicrobial-based catheters aim to eradicate bacteria residing in the vicinity of the catheter surface, they can result in antibiotic resistance, which could have serious implications on patient care.

A novel urinary catheter, the Micro-Patterned Foley catheter has been developed that incorporates a micro-pattern texture on the surface; the texture is too small to see or feel, but has demonstrated an impressive effect in the laboratory inhibiting microbial attachment to the surface and microbial migration along the micro-patterned catheter segments. The objective of the study is to determine whether the novel Micro-Patterned catheter can delay the onset of catheter associated urinary tract infection in catheterized spinal cord injured patients. If successful, this catheter will help improve quality of patient care and reduce cost of care by reducing the need for antibiotic treatment. This finding could extend to other patient populations that require urinary catheterization.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2017-02-01
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-05
• Last Update Submitted: 2017-04-05
• Results First Posted: 2017-04-07
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro-Patterned Foley Catheter	Scanning Electron Microscopy	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter	Foley Catheter Tip Culture	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Micro-Patterned Foley Catheter	Foley Catheter Tip Culture	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Micro-Patterned Foley Catheter	Foley Catheter Insertion	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter	Urine Culture	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Micro-Patterned Foley Catheter	Device Specific Adverse Event Assessment	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter	Scanning Electron Microscopy	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Micro-Patterned Foley Catheter	Urine Culture	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter	Device Specific Adverse Event Assessment	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter	Foley Catheter Insertion	Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy

Primary Outcome Measures

Name	Time	Method
Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection	15 Days	Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.

Secondary Outcome Measures

Name	Time	Method
Assess the Microbial Coverage and Biofilm Formation on Catheter Surface	Day 15 or upon removal of Foley Catheter	Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.
Device Specific Adverse Event Assessments	15 Days	Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.
Time to Occurrence of Asymptomatic Bacteruria or Funguria	15 days	Urine cultures will be obtained every third day to assess for the presence of microbial growth.

Trial Locations

Locations (2)

Michael E. DeBakey Veterans Affairs Medical Center; 🇺🇸 Houston, Texas, United States

James A. Haley Veterans' Hospital; 🇺🇸 Tampa, Florida, United States