Hedican 1976.
Methods | Design: randomised double‐blinded No. eligible: not stated No. randomised: 70 No. analysed: 70 Drop‐outs/withdrawals: none Years of recruitment: 1971 to 1972 Setting: university gynaecology and obstetrics department, USA |
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Participants | Inclusion criteria: women having elective vaginal hysterectomy Exclusion criteria: preoperative infection, taking antibiotics, allergy to study drugs, elevated blood urea Age: not stated Type of hysterectomy: vaginal | |
Interventions | Treatment: cephaloridine (first‐generation cephalosporin) Control: placebo Route: IV, then IM Single/multiple doses: multiple Timing of doses: 1 gram IV at start of operation, 1 gram IM 5 hours postoperatively, 1 gram IM 12 hours postoperatively |
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Outcomes | Postoperative infection, early Pelvic infection |
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Funding | Lilly Company | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | State that "patients were numbered consecutively 1‐70 and randomly assigned..."; no additional details reported |
Allocation concealment (selection bias) | Low risk | Appears to be remote allocation ‐ "patients were ... randomly assigned either the placebo or the study drug by the pharmacy" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Following the completion of the study ... the code was broken"; no details on outcome assessment provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Appears that all participants were analysed |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a conclusive judgement |
Other bias | Unclear risk | Insufficient information to make a conclusive judgement |