Lambert 1984.
Methods | Randomised, controlled Method of randomisation: drawing a card Kind of shunt: ventriculoperitoneal and ventriculoatrial shunts Location: Germany Follow‐up: 6 months Duration: 21 months |
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Participants | Inclusion: any patient undergoing insertion or revision of a CSF shunt Exclusion: organisms resistant to gentamicin on surface swabs or recent surgery for CSF of shunt infection, antibiotics at time of surgery, revision of a colonized shunt system Treatment: 24; control: 20 |
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Interventions | Gentamicin IV/intramuscular (3 mg/kg) and gentamicin intrathecal 5 mg above the level of the revision either into the ventricle or the shunt system versus povidone iodine and a control group | |
Outcomes | Proportion of participants who had shunt infection after new insertion or revision surgery No timing of outcome measurement described |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were allocated to one of three groups by drawing a card" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Povidone iodine and antibiotic can be distinguished |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Povidone iodine and antibiotic can be distinguished |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Exclusions not described |
Selective reporting (reporting bias) | High risk | Study protocol not available and no pre‐specified outcome measures or analysis |
Other bias | High risk | The dose of gentamicin was increased to 10 mg when ventricles were dilated. No cut‐off point for dilatation was described. No documentation about the number of participants with dilatated ventricles could be found |