Kattipattanapong 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 133 adults who underwent ear surgery with a post‐auricular approach in Thailand between May 2010 and May 2011 | |
Interventions | Group 1: hair removal with razor (n = 66) Group 2: no hair removal (n = 70) Product details: a razor was used with a dry shave. Timing of hair removal: not reported. Hair removed by: not reported. Venue for hair removal: not reported. |
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Outcomes | Primary outcome: SSIs as defined by CDC criteria. SSIs within 30 days were recorded, but no details provided as to when they were assessed or by whom. Secondary outcome: factors associated with SSI ‐ demographic data. |
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Notes | Competing interests: none. Sponsorship: none. Funding sources: none | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "block randomization using random allocation software" Comment: consider adequate approach. |
Allocation concealment (selection bias) | Unclear risk | Not reported. Comment: not clear whether the person responsible for allocation to groups would have been able to predict to which group a potential participant would be allocated. |
Blinding (performance bias and detection bias) Care providers blinded | Unclear risk | Not reported. Comment: unclear whether care providers were blinded to intervention allocation. |
Blinding (performance bias and detection bias) Participants blinded | High risk | Not reported. Comment: participants would have been aware of hair removal method. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Comment: unclear whether assessors were blinded to intervention allocation. |
Incomplete outcome data (attrition bias) ITT analysis undertaken | Unclear risk | Not reported. Comment: no discussion of whether participants were analysed in the groups to which they had been allocated. |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | Participants who dropped out are accounted for, and participants were 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. |