Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
|Intraventricular Hemorrhage Subarachnoid Hemorrhage||Device: Bactiseal TM EVD Device: Standard EVD Catheter||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System|
- Number of Infections [ Time Frame: Duration of implanted EVD system to 2 week post implant ]The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
- Days to Proven Infection [ Time Frame: Implantation of EVD System to explant of EVD catheter, an average of ten days ]Number of days to proven infection.
- Class of Bacterial Agent Causing Proven Infection [ Time Frame: Implantation of subject to post implant ]Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD
- Intraluminal Colonization on Catheters [ Time Frame: Implant of subjects to post implant ]Number of catheters with Bacterial colonization verified using fluorescence.
- Device Related Adverse Events [ Time Frame: Implanted subjects to time of explant ]Number of Device Related Adverse Events
- Number of Days With Indwelling Catheter [ Time Frame: Implant of subjects to day of explant ]Days catheter was implanted in subjects
- Average Subject Age [ Time Frame: Implant to subject ]The average subject age
- Diagnosis Requiring EVD Implantation [ Time Frame: Implantation of EVD system ]Primary diagnosis for implantation of EVD system
- Non-infectious Catheter Failure in the MITT Population [ Time Frame: Implant of subject to explant ]Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.
- Time Point of Introduction of Systemic Antibiotic Therapy [ Time Frame: Within 48 hours of implant of subjects to explant ]Time points of then patients received systemic antibiotic therapy
- Hospital Locations for EVD Catheter Placement [ Time Frame: Implantation of subject ]Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).
- Length of Catheter Tunneling Into the Brain [ Time Frame: Implant of subject ]Length of tunneling of EVD catheter in the brain for each analysis population.
- Number of Catheter Insertion Attempts [ Time Frame: Implantation of subject ]Number of insertions needed to place catheter
|Study Start Date:||November 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Bactiseal TM EVD
Bactiseal External Ventricular Drainage System.
Device: Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter
Other Name: EVD,Bactiseal, standard
Active Comparator: Standard EVD Catheter
Standard External Ventricular Device system
Device: Standard EVD Catheter
Standard of care EVD system other than Bactiseal.
Other Name: EVD, ventricular catheters
External ventricular drainage catheters are widely used in the management of Subjects with elevated intra-cranial pressure (ICP) secondary to acute hydrocephalus due to sub-arachnoid hemorrhage, intra-cerebral hemorrhage, intra-ventricular hemorrhage and other causes that obstruct the cerebrospinal fluid (CSF) circulation. However, this mode of treatment could be compromised by the increased risk of catheter related CSF infection.
B-EVD is manufactured using a patented process to impregnate silicone catheters with two antibiotics, rifampin and clindamycin. These antibiotics are impregnated throughout the silicone matrix. After implantation, slow release of both antibiotics at the extra- and intra-luminal catheter surfaces minimizes the likelihood of bacterial colonization. The B-EVD Catheter System has, to date, been well accepted by domestic and European customers. Currently there exists sound scientific rationale and promising bench-top in vitro data to anticipate low levels of ventriculostomy-related infection in Subjects using this system. Published BACTISEAL shunt data and direct feedback from U.S. market experience also support this notion. There are no published clinical studies reporting infection rates with the use of the B-EVD System, making all statements regarding its propensity to minimize clinical risk for catheter-related infection mere speculation and anecdotal. Therefore, Codman proposes to undertake a controlled clinical evaluation of this product to demonstrate its influence on EVD catheter-related infections, using a conventional EVD catheter as a standard of reference.
Immediately following successful screening, the Subject will be randomized to test or control group and will have the appropriate EVD system implanted. The Treatment Phase will cover the duration of the implanted EVD system. Subjects will be monitored for 2 weeks post-explant.
This study is expected to enroll 600 evaluable implanted Subjects at up to 15 Investigational Sites in US, Europe and Asia-Pacific
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197392
|United States, California|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|United States, New York|
|Syracuse, New York, United States, 13213|
|United States, Pennsylvania|
|Hershey, Pennsylvania, United States, 17033|
|Calgary, Alberta, Canada|
|Edmonton, Alberta, Canada|
|Sherbrooke, Quebec, Canada|
|Xuan Wu Hospital|
|Paris, France, 75013|
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Oslo, Norway, NO-0027|
|National Neuroscience Institute|
|Singapore General Hospital|
|Bristol, United Kingdom, BS 16 1LE|
|Leeds, United Kingdom|
|Salford, United Kingdom|
|Study Director:||J. Thomas Megerian, MD, PhD||Unaffilliated|