At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Written informed consent from subject or authorized family member/legal representative, or documented ethical/legal alternative if subject unable to consent and no representative available
- ✓Willingness to participate for duration of implanted EVD system and comply with protocol requirements
- ✕Enrollment or participation in another CNS/spinal cord anti-microbial drug or device trial within preceding 30 days
- ✕Pregnancy or lactation
- ✕Suspected or documented allergy to EVD system materials including silicone, rifampin, or clindamycin
- ✕Positive CSF culture prior to EVD implant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
In Brief
A Phase 4 clinical trial evaluating Bactiseal TM EVD and Standard EVD Catheter for Intraventricular Hemorrhage and Subarachnoid Hemorrhage. Completed, enrolled 434 participants across 20 sites in 8 countries.
Detailed 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
Study Details
Timeline
Interventions
Standard of care implantation of external ventricular drainage catheter
Standard of care EVD system other than Bactiseal.