A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
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|ClinicalTrials.gov Identifier: NCT00280904|
Recruitment Status : Completed
First Posted : January 24, 2006
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
|Condition or disease||Intervention/treatment|
|Hydrocephalus||Device: Shunt catheter|
Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.
Depending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%
This prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days.
|Study Type :||Observational|
|Actual Enrollment :||433 participants|
|Official Title:||A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
- Device: Shunt catheter
standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.
- Number of Subjects With Shunt Infections [ Time Frame: Implantation to Explant ]Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
- Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures [ Time Frame: April 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280904
|United States, Illinois|
|Children's memorial Hospital|
|Chicago, Illinois, United States, 60614|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Prince of Wales Hospital|
|Ua Shan Hospital|
|Shanghai, China, 200040|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|All India Insitute of Medical Sciences|
|New Delhi, India, 110029|
|National Neuroscience Institute|
|Singapore, Singapore, 308433|
|Study Chair:||Paul Steinbok, MBBS, FRCSC||University of British Columbia|