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Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

NCT00197392 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2013-11-05

Study results available
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Summary

The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study

Conditions

  • Intraventricular Hemorrhage
  • Subarachnoid Hemorrhage

Interventions

DEVICE

Bactiseal TM EVD

Standard of care implantation of external ventricular drainage catheter

DEVICE

Standard EVD Catheter

Standard of care EVD system other than Bactiseal.

Sponsors & Collaborators

  • Codman & Shurtleff

    lead INDUSTRY

Principal Investigators

  • J. Thomas Megerian, MD, PhD · Unaffilliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States
  • Canada
  • China
  • France
  • Hong Kong
  • Norway
  • Singapore
  • United Kingdom

Study Locations

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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 NCT00197392 on ClinicalTrials.gov