Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197392
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2005-09-13
Brief Title:
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage EVD System
Sponsor:
Codman Shurtleff
Organization:
Codman Shurtleff
Study Overview
Official Title:
Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage EVD System
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 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
Detailed Description:
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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
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?:
None