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

NCT02198833 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-04-07

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Urine Culture

Obtain urine culture every third day

DEVICE

Foley Catheter Tip Culture

Catheter Tip Roll Plate Culture

DEVICE

Scanning Electron Microscopy

Houston Site Only

PROCEDURE

Device Specific Adverse Event Assessment

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

PROCEDURE

Foley Catheter Insertion

Insert Foley catheter for 15 day duration

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Rabih O Darouiche, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198833 on ClinicalTrials.gov