Govender 2003.
Methods | Randomisation, controlled Method of randomisation: unclear Kind of shunt: ventriculoperitoneal shunts Location: United Kingdom, multicentre Follow‐up: median of 9 months (range 1 to 20 months) Duration: unclear |
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Participants | Inclusion: patients with hydrocephalus who had been identified primarily as uninfected Exclusion: CSF infection, pregnant or lactating, known sensitivity to rifampin or clindamycin, harboured an open and uncorrected myelomeningocoele or encephalocoele Treatment: 50; control: 60 |
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Interventions | Ventriculoperitoneal shunt impregnated with clindamycin and rifampin (Bactiseal; Codman, Johnson & Johnson, Boston, MA) versus a control shunt | |
Outcomes | Proportion of participants who had shunt infection Days to infection ranged from 6 days to 354 days |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The difference in the colour of the shunts dictated the need for a blind study" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 15 participants (9.8%) lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Study protocol well defined and pre‐specified outcome measures and analysis were available |
Other bias | Low risk | The study appears to be free of other sources of bias |