Hydrocephalus Clinical Trial
Official title:
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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