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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study to Assess the Efficacy of a Novel Micro-Patterned Foley Catheter to Reduce Catheter-Associated UrinaryTract Infection Among Spinal Cord Injury Patients

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Biological: Urine Culture
* Device: Foley Catheter Tip Culture
* Device: Scanning Electron Microscopy
* Procedure: Device Specific Adverse Event Assessment
* Procedure: Foley Catheter Insertion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-Patterned Foley Catheter<br>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy | Biological: Urine Culture<br>* Obtain urine culture every third day<br>Device: Foley Catheter Tip Culture<br>* Catheter Tip Roll Plate Culture<br>Device: Scanning Electron Microscopy<br>* Houston Site Only<br>Procedure: Device Specific Adverse Event Assessment<br>* Assessment will be made of catheter patency and/or trauma related to catheter placement<br>Procedure: Foley Catheter Insertion<br>* Insert Foley catheter for 15 day duration<br>|
| Active Comparator: Standard-of-Care Foley Catheter<br>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy | Biological: Urine Culture<br>* Obtain urine culture every third day<br>Device: Foley Catheter Tip Culture<br>* Catheter Tip Roll Plate Culture<br>Device: Scanning Electron Microscopy<br>* Houston Site Only<br>Procedure: Device Specific Adverse Event Assessment<br>* Assessment will be made of catheter patency and/or trauma related to catheter placement<br>Procedure: Foley Catheter Insertion<br>* Insert Foley catheter for 15 day duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection | 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. | 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Occurrence of Asymptomatic Bacteruria or Funguria | Urine cultures will be obtained every third day to assess for the presence of microbial growth. | 15 days | 
| Assess the Microbial Coverage and Biofilm Formation on Catheter Surface | 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. | Day 15 or upon removal of Foley Catheter | 
| Device Specific Adverse Event Assessments | 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. | 15 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infection, Bacteriuria, Transurethral Foley Catheter, Suprapubic Foley Catheter, Spinal Cord injury