The SiLuDrain Trial: a prospective randomized controlled trial comparing standard versus silver-impregnated lumbar...

Catheter-associated cerebrospinal fluid (CSF) infection remains a serious event, especially for patients in neurocritical care units. The use of external ventricular drain (EVD) catheters impregnated with antimicrobial substances has led to a significant reduction of infection rates. This study was undertaken to compare the use of antimicrobial, silver-impregnated external lumbar drains (si-ELDs) and conventional ELDs.

Patients with an indication for ELD placement were randomized to receive either a conventional or an si-ELD catheter. Regular assessment for CSF infections and device-related complications was performed. Neurosurgeons placing the ELD rated the usability and handling of the catheter on a 6-item ordinal performance scale (range: 1, very bad, to 5, very good). All microorganisms isolated in this study were tested for silver-susceptibility via a catheter-roll method.

A total of 48 patients were enrolled in the trial. The si-ELD catheters showed a nonsignificantly lower infection rate compared to conventional ones (4.2% vs 16.7%, p = 0.16). The majority of infections were caused by Staphylococcus species. Device-related complications occurred significantly less often with silver-impregnated-catheters than with conventional ones (8.3% vs 37.5%, p = 0.02). The usability was rated significantly better for si-ELDs (p = 0.003). Antimicrobial susceptibility was shown for si-ELDs against various Staphylococcus spp., but Candida parapsilosis and Escherichia coli were not affected by this antimicrobial agent.

Silver-impregnated ELD catheters, which could potentially reduce the number of CSF infections, show significantly better properties in regard to handling and fewer device-related complications. Whether they are superior to antibiotic-impregnated catheters or a clinical regimen involving antibiotic prophylaxis remains to be proven.Clinical trial registration no.: DRKS00013513 (Deutsches Register Klinischer Studien).