Ledger 1973.
Methods | Design: randomised double‐blinded No. women eligible: 164 No. women randomised: 100 No. women analysed: 100 Drop‐outs/withdrawals: none Years of recruitment: 1970 to 1972 Setting: University of Michigan Medical Centre |
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Participants | Inclusion criteria: premenopausal women having vaginal hysterectomy Exclusion criteria: allergy to study drugs, high preoperative blood urea, already receiving prophylactic antibiotics, "vaginal approach was decided upon in the operating room" Age: mean 35 years Type of hysterectomy: vaginal |
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Interventions | Treatment: 1 gram cephaloridine (first‐generation cephalosporin) Control: placebo Route: not stated Single/multiple doses: multiple Timing of doses: first dose on call to operating room, second dose on return from recovery room, third dose at bedtime night of operation |
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Outcomes | Postoperative infection, early Urinary tract infection Pelvic infection Postoperative fever Need for therapeutic antibiotics Hospital length of stay Follow‐up: to hospital discharge *Also reports "other morbidity" ‐ no separate data for "other serious infections" |
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Funding | Eli Lilly Company | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | Low risk | States that allocation was "assigned by the pharmacy service" ‐ probably remote allocation |
Blinding (performance bias and detection bias) All outcomes | Low risk | States that "the code identifying placebo or active drug was broken only after the patient had been discharged and the clinical summary sheets...completed" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported no drop‐outs |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a conclusive judgement |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |