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

NCT ID: NCT02198833

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-07-31

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Micro-Patterned Foley Catheter

Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy

Group Type: EXPERIMENTAL

Urine Culture

Intervention Type: BIOLOGICAL

Obtain urine culture every third day

Foley Catheter Tip Culture

Intervention Type: DEVICE

Catheter Tip Roll Plate Culture

Scanning Electron Microscopy

Intervention Type: DEVICE

Houston Site Only

Device Specific Adverse Event Assessment

Intervention Type: PROCEDURE

Assessment will be made of catheter patency and/or trauma related to catheter placement

Foley Catheter Insertion

Intervention Type: PROCEDURE

Insert Foley catheter for 15 day duration

Standard-of-Care Foley Catheter

Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy

Group Type: ACTIVE_COMPARATOR

Urine Culture

Intervention Type: BIOLOGICAL

Obtain urine culture every third day

Foley Catheter Tip Culture

Intervention Type: DEVICE

Catheter Tip Roll Plate Culture

Scanning Electron Microscopy

Intervention Type: DEVICE

Houston Site Only

Device Specific Adverse Event Assessment

Intervention Type: PROCEDURE

Assessment will be made of catheter patency and/or trauma related to catheter placement

Foley Catheter Insertion

Intervention Type: PROCEDURE

Insert Foley catheter for 15 day duration

Interventions

Urine Culture

Obtain urine culture every third day

Intervention Type: BIOLOGICAL

Foley Catheter Tip Culture

Catheter Tip Roll Plate Culture

Intervention Type: DEVICE

Scanning Electron Microscopy

Houston Site Only

Intervention Type: DEVICE

Device Specific Adverse Event Assessment

Assessment will be made of catheter patency and/or trauma related to catheter placement

Intervention Type: PROCEDURE

Foley Catheter Insertion

Insert Foley catheter for 15 day duration

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rabih Darouiche

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabih O Darouiche, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

James A. Haley Veterans' Hospital

Tampa, Florida, United States

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

H-32673

Identifier Type: OTHER

Identifier Source: secondary_id

SC120028

Identifier Type: -

Identifier Source: org_study_id