Abouzari 2009.
Study characteristics | ||
Methods | RCT | |
Participants | 195 people undergoing elective cranial surgery in Iran between March 2005 and December 2007 | |
Interventions | 3 preoperative surgical site treatments involving removal, or no removal, of scalp hair:
Group 1: removal with a razor (n = 65)
Group 2: removal with hair clippers (n = 65)
Group 3: no hair removal (n = 65) Product details: no details are given for the razor, the clippers were "barbers clippers". Time of hair removal: no details given. Hair removed by: not specified. Venue for hair removal: not reported. |
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Outcomes | Outcome: infection. Defined as including presence of pus, bacterial culture, development of postoperative meningitis and microbiology. Participants were followed up at 3 or 4 weekly intervals until complete wound healing or the development of an infection. | |
Notes | No statistical test of significance used. No funding sources mentioned. No details of conflict of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly allocated" Comment: no further details given. |
Allocation concealment (selection bias) | Unclear risk | No details reported. Comment: not clear whether the person allocating people to groups would have been able to predict the group to which a potential participant would be allocated. |
Blinding (performance bias and detection bias) Care providers blinded | Unclear risk | No details reported. Comment: unclear whether care providers were blinded to intervention allocation. |
Blinding (performance bias and detection bias) Participants blinded | High risk | No details reported. Comment: participants would be aware of hair removal method. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details reported. Comment: unclear whether assessors were blinded to intervention allocation. |
Incomplete outcome data (attrition bias) ITT analysis undertaken | Unclear risk | No details reported. Comment: no information provided regarding whether participants were analysed in the groups to which they were allocated. |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | Participants who dropped out are accounted for, and participants are distributed evenly across groups. Comment: the number of dropouts was judged to be unlikely to have altered the result, even in a worst‐case scenario (i.e. assuming that those that dropped out developed an SSI). |
Selective reporting (reporting bias) | Low risk | Main outcomes reported. Comment: unlikely to be affected by reporting bias. |
Other bias | Low risk | Comment: participant groups were equal or similar. |