Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
1 other identifier
interventional
434
8 countries
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2004
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
November 5, 2013
CompletedNovember 5, 2013
October 1, 2013
5.1 years
September 13, 2005
March 2, 2012
October 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Infections
The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
Duration of implanted EVD system to 2 week post implant
Secondary Outcomes (12)
Days to Proven Infection
Implantation of EVD System to explant of EVD catheter, an average of ten days
Class of Bacterial Agent Causing Proven Infection
Implantation of subject to post implant
Intraluminal Colonization on Catheters
Implant of subjects to post implant
Device Related Adverse Events
Implanted subjects to time of explant
Number of Days With Indwelling Catheter
Implant of subjects to day of explant
- +7 more secondary outcomes
Study Arms (2)
Bactiseal TM EVD
EXPERIMENTALBactiseal External Ventricular Drainage System.
Standard EVD Catheter
ACTIVE COMPARATORStandard External Ventricular Device system
Interventions
Standard of care implantation of external ventricular drainage catheter
Standard of care EVD system other than Bactiseal.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Syracuse, New York, 13213, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Tiantan Hospital
Beijing, China
Xuan Wu Hospital
Beijing, China
Unknown Facility
Angers, France
Unknown Facility
Lille, France
Unknown Facility
Paris, 75013, France
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Unknown Facility
Oslo, NO-0027, Norway
National Neuroscience Institute
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Unknown Facility
Bristol, BS 16 1LE, United Kingdom
Unknown Facility
Leeds, United Kingdom
Unknown Facility
Salford, United Kingdom
Related Publications (8)
Codman in house testing reports, TR2213 and PVER99-133 Addendum
BACKGROUNDBayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.
BACKGROUNDBayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9. doi: 10.1136/jnnp.52.5.605.
PMID: 2732730BACKGROUNDBayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51. doi: 10.3171/jns.1997.87.2.0247.
PMID: 9254088BACKGROUNDGovender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9. doi: 10.3171/jns.2003.99.5.0831.
PMID: 14609161BACKGROUNDLozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.
PMID: 12182415BACKGROUNDSchierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000. doi: 10.1016/0142-9612(94)90080-9.
PMID: 7841297BACKGROUNDZabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30. doi: 10.3171/jns.2003.98.4.0725.
PMID: 12691395BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- J. Thomas Megerian, MD
- Organization
- Codman & Shurtleff, Inc
Study Officials
- STUDY DIRECTOR
J. Thomas Megerian, MD, PhD
Unaffilliated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
November 1, 2004
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
November 5, 2013
Results First Posted
November 5, 2013
Record last verified: 2013-10