Amland 1995.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 339 children, adults, and elderly (macrolide n = 171, placebo n = 168) Age in years mean (range): male: macrolide: 30 (7 to 85), placebo: 28 (6 to 84); female: macrolide 33 (6 to 84), placebo: 33 (7 to 82) Setting: secondary care |
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Interventions |
Indication: prevention of postoperative wound infections Type of macrolide: azithromycin Route: per oral Dose per day: 1000 mg (maximum) Duration of treatment: 1 day Total treatment dose: 1000 mg (maximum) |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: no Adverse events ascertainment: unclear Adverse events: data reported Antimicrobial resistance: not reported Death: not reported |
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Funding sources | None stated. Reports that the study was supported by Pfizer, who provided the study medication | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed in blocks of 10 using a computer‐generated chart. |
Allocation concealment (selection bias) | Low risk | Central allocation |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if participants and clinicians were blinded to treatment groups |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout, similar across groups |
Selective reporting (reporting bias) | Unclear risk | Adverse events not stated as an outcome, unclear ascertainment. However, adverse events reported. |
Other bias | Low risk | None were identified. |