BACKGROUND: Evaluation of antibiotic-impregnated (AI) and ionized silver particle coated external ventricular drainage catheters (EVD) in patients with subarachnoid (SAH) or intracranial hemorrhage (ICH). METHODS:Between February 2011 and June 2012, 40 patients with acute hydrocephalus due to SAH, ICH or intraventricular hemorrhage were enrolled in a prospective, randomized, mono-center pilot study. Primary endpoints were defined as: number of events of cerebrospinal fluid (CSF) infections. Secondary endpoints were defined as: neurosurgical complications following the placement of the EVD, number of revisions of EVD catheters, and cost effectiveness. RESULTS: Sixty-one EVD placements in 40 patients, 32 antibiotic-coated (Bactiseal(®)), 29 silver-bearing catheters (VentriGuard(®)), have been performed. Confirmed or high suspicion of CSF infections occurred in 11 out of 61 events (confirmed infection: p = 0.71, probable infection: p = 0.90). Revisions of EVD were needed in 13 cases (22 %) due to CSF infection, dysfunction, impaired healing, or malplacement (p = 0.37). CONCLUSION: Regarding CSF infection rate and dysfunction, no statistical significant differences between the two EVD catheters Bactiseal(®) versus VentriGuard(®) were found. The silver-bearing catheter might offer a safe and cost-conscious alternative to the AI catheter.
RCT Entities:
BACKGROUND: Evaluation of antibiotic-impregnated (AI) and ionizedsilver particle coated external ventricular drainage catheters (EVD) in patients with subarachnoid (SAH) or intracranial hemorrhage (ICH). METHODS: Between February 2011 and June 2012, 40 patients with acute hydrocephalus due to SAH, ICH or intraventricular hemorrhage were enrolled in a prospective, randomized, mono-center pilot study. Primary endpoints were defined as: number of events of cerebrospinal fluid (CSF) infections. Secondary endpoints were defined as: neurosurgical complications following the placement of the EVD, number of revisions of EVD catheters, and cost effectiveness. RESULTS: Sixty-one EVD placements in 40 patients, 32 antibiotic-coated (Bactiseal(®)), 29 silver-bearing catheters (VentriGuard(®)), have been performed. Confirmed or high suspicion of CSF infections occurred in 11 out of 61 events (confirmed infection: p = 0.71, probable infection: p = 0.90). Revisions of EVD were needed in 13 cases (22 %) due to CSF infection, dysfunction, impaired healing, or malplacement (p = 0.37). CONCLUSION: Regarding CSF infection rate and dysfunction, no statistical significant differences between the two EVD catheters Bactiseal(®) versus VentriGuard(®) were found. The silver-bearing catheter might offer a safe and cost-conscious alternative to the AI catheter.
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