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. 2016 Jan 22;2016(1):CD004288. doi: 10.1002/14651858.CD004288.pub3

Hajipour 2006.

Methods Cluster randomised controlled trial
 Generation of random number sequence: random number table
 Allocation concealment: no details given
 Blinding: microbiologist was blinded
 A priori sample calculations: no
 Antisepsis protocol: yes
 Withdrawals: no details given
 Intention‐to‐treat analysis: no
 Clear inclusion or exclusion criteria: no
Participants 4 surgeons working in a trauma surgery
 Baseline comparability: surgeon's grade, order of patient on the operating list, duration of surgery
Interventions Group 1 ‐ 3 min scrub using aqueous chlorhexidine gluconate
 Group 2 ‐ 3 min application of 0.5% chlorhexidine gluconate in 70% alcohol
All surgeons washed with chlorhexidine (no further detail) for 5 min for first procedure with thorough cleaning under fingernails.
Outcomes Outcome measure: CFUs on participants' hands
 Method of testing: finger press testing with agar plates
 Timing of testing: at the end of the surgical procedure
Notes The 4 surgeons, who were not blinded, were randomised once and tested 53 times
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Orthopaedic surgeons were allocated to one of two different hand‐washing protocols using a randomisation table"
 
Comment: evidence of random sequence generation, therefore judged as low risk
Allocation concealment (selection bias) Unclear risk Quote: "[T]he surgeon was randomised to wash for 5 min with either chlorhexidine or alcohol gel"
 
Comment: no evidence that there was an attempt at allocation concealment
Blinding (performance bias and detection bias) 
 All outcomes ‐ Blinding participants Unclear risk Quote: "The hand‐washing protocol dictated that all surgeons should wash for 5 min with chlorhexidine for their first case with thorough cleaning under the fingernails. Thereafter, the surgeon was randomised to wash for 5 min with either the chlorhexidine or alcohol gel. Alcohol was allowed to dry on the hands prior to double gloving".
 
Comment: no evidence that participants or personnel were blinded to intervention
Blinding (performance bias and detection bias) 
 All outcomes ‐ Blinding care givers Unclear risk Quote: "The hand‐washing protocol dictated that all surgeons should wash for 5 min with chlorhexidine for their first case with thorough cleaning under the fingernails. Thereafter, the surgeon was randomised to wash for 5 min with either the chlorhexidine or alcohol gel. Alcohol was allowed to dry on the hands prior to double gloving".
 
Comment: no evidence that participants or personnel were blinded to intervention
Blinding (performance bias and detection bias) 
 All outcomes ‐ Blinding outcome assessors Low risk Quote: "The number of bacterial colonies present after 24 h and 48 h of incubation were recorded for each agar plate by a microbiologist blinded to the washing protocol used"
 
Comment: adequate blinding of assessment outcome
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Overall, 41 procedures and 82 episodes of handwashings were included in the study. Two episodes were discarded due to contamination at the time of glove removal. There was no incidence of outer glove perforation during this study"
 
Comment: good evidence to suggest losses to follow‐up were accounted for and there was minimal effect of attrition bias
Selective reporting (reporting bias) Low risk No direct quotes, but the assessment variable of bacterial colonisation after different methods of handwashing (which was outlined in the methodology) is accounted for in the results.
Other bias Unclear risk This appears to be a clustered randomised trial; it does not seem that clustering was taken into account in the analysis.