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Silver impregnated external ventricular drains reduce the incidence of CSF infection and the need for post-EVD shunt placement: results of the SILVER trial
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Veröffentlicht: | 28. April 2011 |
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Objective: The SILVER (Silver Impregnated Line Versus EVD Randomised) trial is a randomised double-blinded controlled trial designed to evaluate the effectiveness of silver impregnation on CSF infection rates after insertion of an external ventricular catheter (EVD).
Methods: Patients satisfying strict inclusion criteria were randomised to receiving either a silver impregnated EVD (Spiegelberg ((GmbH & Co.) KG, Tempowerkring 4, 21079 Hamburg, Germany), or a plain catheter. Both were colour coded as part of the blinding process and constructed to look identical. Routine CSF sampling was performed and sent for microscopy, culture and sensitivity. CSF samples were collected at least every 72 hours whilst the catheter remained in place. Primary (CSF infection rate) and secondary (duration of EVD placement, number of revisions, requirement for shunts, total duration from admission to discharge and Glasgow Coma Scale (GCS) on discharge) end points were assessed.
Results: Data from 278 patients were available for analysis (plain arm =140, silver arm =138). The overall infection rate was 16.9 % (47/278); 21.4% (30/140) for plain and 12.3% (17/138) for silver EVD (p=0.042). The silver arm had a consistently lower infection risk throughout the interim analysis period, and demonstrated a different time to infection profile. In addition, patients with EVDs who suffered a catheter-related CSF infection had more than double the risk of requiring a later shunt insertion (44.7%), particularly if the EVD had demonstrated infection (53.3% vs. 29.4% conversion rate).
Conclusions: The SILVER trial represents the first class I evidence of a benefit of one type of EVD over another in terms of infection rate. Secondary benefits were seen in subsequent shunt conversion rate, which represents a significant positive health care benefit.