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External ventricular catheters are used for intracranial pressure monitoring and temporary cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent literature. Previous prospective studies in the investigators' unit have shown that the use of dual antibiotics prophylaxis in patients with external ventricular drain was associated with decreased incidence of CSF infection but was complicated with opportunistic extracranial infections. The current practice is to cover with prophylactic dual antibiotics unless guided by microbiology results for all patients with external ventricular drain. In recent years, cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been available. Experimental studies have shown that they provide protection against staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56 days. Theoretically, they provide the antibiotic prophylaxis locally without the associated complications of systemic antibiotics.
It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Objective:
Design: Prospective randomized controlled trial
Hypothesis: The use of antibiotics-impregnated catheter instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infection and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Method: After ventricular catheter insertion, patients will be randomized into one of the two groups:
Primary outcome variable: Cerebrospinal fluid infection and extracranial infection.
Sample size: We aim to recruit a total of 180 patients with 90 patients in each arm and expect to complete patient recruitment in 2-3 years. The calculation is based to detect a difference of nosocomial infection rate between 20% and 40%, with 5% level of significance and 80% power.
Projected results and significance:
The project has a good chance to be the first clinical study to the outcome and cost impacts of antibiotic-impregnated ventricular catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated) |
|
| 2 | Placebo Comparator | Plain ventricular catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics-impregnated ventricular catheter (Bactiseal®) | Device | Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid infection rate | First 30 days | |
| Extracranial infection rate | First 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | At discharge and six months | |
| Glasgow Outcome Scale Extended | At discharge and at six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George KC Wong, FRCSEd(SN) | Chinese University of Hong Kong | Principal Investigator |
| George KC Wong, FRCSEd(SN) | Chinese University of Hong Kong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong | Hong Kong | Hong Kong | 852 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20466698 | Derived | Wong GK, Ip M, Poon WS, Mak CW, Ng RY. Antibiotics-impregnated ventricular catheter versus systemic antibiotics for prevention of nosocomial CSF and non-CSF infections: a prospective randomised clinical trial. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1064-7. doi: 10.1136/jnnp.2009.198523. Epub 2010 May 12. |
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| Plain ventricular catheter (Codman EDS II/III) | Device | Plain ventricular catheter |
|
|
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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