Blomstedt 1985.
| Methods | Randomized, controlled Method of randomisation: unclear Kind of shunt: ventriculoatrial shunts Location: Finland Follow‐up: for a minimum of 6 months Duration: 38 months |
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| Participants | Inclusion: all patients undergoing ventriculoatriostomy or an external ventriculostomy were included in the trial Exclusion: patients under 12 years of age, patients allergic to sulfamethoxazole or trimethoprim, patients who received antibiotics during the preceding week and patients who already had a shunt in place when the trial started Treatment: 62, control: 60 |
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| Interventions | Trimethoprim (80 mg) and sulphamethoxazole (400 mg) versus plain vehicle (sodium hydroxide, dietholamin, sodium pyrosulfis, ethanol, phenylcarbinol and propylengeglycol mixed in sterile water) Intravenous administration was performed just before surgery and 3 times postoperatively with intervals of 12 hours |
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| Outcomes | Proportion of participants who had shunt infection Time between surgery and infection was up to 24 months |
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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 | Ampoules filled with trimethoprim‐sulphamethoxazole or placebo were coded by Hoffmann‐La Roche (supplier) and ampoules were administered to every participant just before surgery |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Clinicians and pharmacist did not know which group a particular number belonged" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | After all the data had been collected and fed into a computer file the key to the code was given to the investigators by Hoffmann‐La Roche |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 26 exclusions, well defined in text |
| Selective reporting (reporting bias) | Low risk | No study protocol available but it is clear that the published report includes all expected outcomes |
| Other bias | Low risk | The study appears to be free of other sources of bias |