Holman 1978.
| Methods | Design: randomised double‐blinded No. eligible: not stated No. randomised: not stated No. analysed: 206 Drop‐outs/withdrawals: not stated Years of recruitment: not reported Setting: Grady Memorial Hospital, United States |
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| Participants | Inclusion criteria: all women admitted for elective vaginal or abdominal hysterectomy Exclusion criteria: allergy to study drugs, fever in past 2 weeks, fever or infection on admission, antibiotics in past 2 weeks, requirement for antibiotics for other indications Age: mean (intervention vs control): 37.8 years vs 38.5 years (abdominal hysterectomy); 27.7 years vs 30.4 years (vaginal hysterectomy) Type of hysterectomy: abdominal or vaginal | |
| Interventions | Treatment: cefazolin (first‐generation cephalosporin), Control: placebo Route: first dose IM, then IM or IV Single/multiple doses: multiple Timing of doses: first dose on call to operating room, second dose on return from recovery room, third dose 6 hours later Follow‐up: postoperative and "after discharge from the hospital" |
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| Outcomes | Abdominal wound infection Urinary tract infection Pelvic infection Need for systemic antibiotics Hospital length of stay (no SDs) *For abdominal hysterectomy, data separated into premenopausal and postmenopausal. For vaginal hysterectomy, only premenopausal data reported for most outcomes. Therefore, data related to postmenopausal vaginal hysterectomy (n = 6) not included in this review Follow‐up: to hospital discharge |
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| Funding | Smith Kline & French, Philadelphia, Pennsylvania, USA | |
| 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 | Reported that "patients were...assigned a study number...from a random table maintained by the pharmacy service" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Reported that "the code was not broken until the patient had been discharged and evaluated..." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Proportions of withdrawals and reasons for withdrawals not reported |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a conclusive judgement |
| Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |