Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-04-15 @ 2:54 PM
Study NCT ID:
NCT02198833
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Clinical Study to Assess the Efficacy of a Novel Micro-Patterned Foley Catheter to Reduce Catheter-Associated UrinaryTract Infection Among Spinal Cord Injury Patients
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study catheter manufacturing issues. Poor enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H-32673 | OTHER | Baylor College of Medicine | View |