Status:
COMPLETED
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Lead Sponsor:
Codman & Shurtleff
Conditions:
Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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) ...
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...
Eligibility Criteria
Inclusion
- The Subject is 18 years or older.
- The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.
- The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.
Exclusion
- Within the preceding 30 days, the Subject has enrolled or participated in another trial utilizing an anti-microbial drug or medical device implanted in or directly influencing the CNS and/or spinal cord.
- The Subject is pregnant or lactating.
- The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.
- The Subject has a positive CSF culture prior to EVD implant.
- The Subject is immunocompromised.
- The Subject requires more than one ventricular catheter concurrently.
- The Subject has had an EVD catheter within the previous 30 days.
- The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.
- The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.
- The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.
- The Subject is a prisoner.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT00197392
Start Date
November 1 2004
End Date
January 1 2010
Last Update
November 5 2013
Active Locations (20)
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1
Los Angeles, California, United States, 90033
2
Gainesville, Florida, United States, 32610
3
Syracuse, New York, United States, 13213
4
Hershey, Pennsylvania, United States, 17033