Britt 1977.
| Methods | Placebo‐controlled RCT | |
| Participants | 215 female patients entered into the study and randomised Inclusion criteria: Undergoing elective gynaecological surgery and who received a urinary catheter or supra‐pubic catheter at the time of surgery for at least one day Exclusion criteria: Rapidly or ultimately fatal disease, active clinical infection, allergy to penicillins or cephalosporins Losses post randomisation: |
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| Interventions | Group 1 (n = 96): Cefazolin sodium 500 mg was given at the time of operation, and each subsequent dose was given at 8‐hour intervals, IV or IM, for a total of nine doses (= three days). Group 2 (n = 100): Placebo was given at the time of operation, and each subsequent dose was given at 8‐hour intervals, IV or IM, for a total of nine doses (= three days). |
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| Outcomes | Bacteriuria during period of antibiotic prophylaxis (days 1‐3) (102> CFU/mL for urinary catheter and 105> CFU/mL for MSU):
Group 1 1/96 Group 2 9/100 Secondary outcomes: febrile morbidity, catheter days, types of organisms |
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| Notes | A urine sample was obtained at the time of catheter insertion and daily from the drainage tube. A clean‐voided specimen was taken on discharge when the catheter was already removed. Remark: Group 1: 6 supra pubic/90 urinary catheters (0.07) Group 2: 12 supra pubic/88 urinary catheters (0.14) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Hospital pharmacy provided a randomisation schedule. |
| Allocation concealment (selection bias) | Low risk | Hospital pharmacy provided a randomisation schedule. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote "Neither the attending physicians, study personnel, nor nursing personnel were aware of the treatment regime assigned by the pharmacy". Blinding by patients not stated. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 8.8% attrition (19 patients were excluded: 14 patients were bacteriuric at the time of catheter insertion, five patients were catheterised for less than one day). |
| Selective reporting (reporting bias) | Unclear risk | Reports all prespecified outcomes but we were unable to access the trial protocol. |
| Incomplete outcome data (ITT analysis) | High risk | No ITT analysis stated. |
| Timing of outcome assessment similar in all groups | Low risk | All participants assessed on third day. |
| Other bias | Unclear risk | Public Health Service grant plus a grant for Ely Lilly & Co. Indianapolis, Ind. |