Vergara‐Fernandez 2010.
| Methods | Parallel group randomised controlled trial. Unit of randomisation and analysis is patient Generation of random number sequence: not reported Allocation concealment: sealed envelopes, no further information Blinding: not reported A priori sample calculations: no Antisepsis protocol: no Withdrawals: no patient withdrawals for evaluation of SSI; CFUs only assessed for 20% of staff but all included in analysis. Intention‐to‐treat analysis: yes Clear inclusion or exclusion criteria: types of surgery only |
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| Participants | 400 staff classified as surgeons, "instrumentalists" and helpers 100 patients undergoing clean or clean‐contaminated surgery |
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| Interventions | Group 1 ‐ aqueous scrub with 4% chlorhexidine gluconate with brush and sterile water. Mean duration of scrub 3.9 (SD 1.07) min. Group 2 ‐ alcohol rub with 61% ethanol, 1% chlorhexidine gluconate. Mean duration 2.0 (SD 0.47) min. |
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| Outcomes | SSI after 1 month (CDC criteria; method of diagnosis not further reported) CFUs on hands (20% of personnel only): reports number of personnel with positive cultures (no further detail) |
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| Notes | Only 20% of the 400 enrolled staff were assessed for bacteria on hands; these were classified as having or not having a positive culture. No data on number of CFUs on hands were reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Just says "used closed envelopes" |
| Allocation concealment (selection bias) | Unclear risk | Just says "used closed envelopes" |
| Blinding (performance bias and detection bias) All outcomes ‐ Blinding participants | Unclear risk | No information given but interventions clearly differed |
| Blinding (performance bias and detection bias) All outcomes ‐ Blinding care givers | Unclear risk | No information given but interventions clearly differed |
| Blinding (performance bias and detection bias) All outcomes ‐ Blinding outcome assessors | Unclear risk | No information on blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on all patients reported for SSI Data on 20% of personnel collected for CFUs; results reported for all those collected |
| Selective reporting (reporting bias) | Low risk | All specified outcomes reported |
| Other bias | Low risk | No other sources of bias detected |