Bullock 1988.
Methods | Randomized, controlled Method of randomisation: unclear Kind of shunt: ventriculoperitoneal shunts Location: South Africa Follow‐up: 90 days after surgery Duration: unclear |
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Participants | Inclusion: patients undergoing "clean" neurosurgical operative procedures Exclusion: patients with known piperacillin hypersensitivity or allergy, patients who had undergone a neurosurgical operation within a month prior to study and patients who had received any antibiotic therapy within 7 days prior to the study Treatment: 48, control 48 |
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Interventions | Piperacillin IV 35 mg/kg 30 to 60 minutes prior to surgery and 2 doses at 6 and 12 hours postoperatively Control: placebo (saline) |
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Outcomes | Sepsis (wound, meningitis) 3 cases of sepsis occurred within 22 days after surgery |
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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) | Low risk | "Allocation of antibiotic or placebo was carried out using a random number list" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Investigators remained blinded until the end of the study" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 participants were excluded, exclusions were well described. A Chi² test was performed in order to check for statistically significant differences between exclusions in the treatment and placebo group. No statistical difference was found |
Selective reporting (reporting bias) | Unclear risk | Not well described |
Other bias | Unclear risk | 35 protocol deviations occurred, which could cause bias in outcome, even when statistical analysis both including and excluding these protocol deviations show no statistical differences |