Court‐Brown 1981.
Study characteristics | ||
Methods | RCT | |
Participants | 418 people undergoing abdominal surgery (except colostomy) in Scotland between November 1977 and October 1978 | |
Interventions | Group 1: hair removal with a razor (n = 137)
Group 2: hair removal with depilatory cream (n = 126)
Group 3: no hair removal (n = 141) Product details: the razors were disposable safety razors with a wet shave, the cream was Veeto. Timing of hair removal: 18 to 24 hours before elective surgery and within 6 hours before emergency surgery. Hair removed by: not specified. Venue for hair removal: not reported. |
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Outcomes | Primary outcome: wound infection defined by presence of pus. Wounds were assessed daily whilst in hospital, and at 28 days postoperatively, unclear by whom. Secondary outcome: acceptability of each method based on "information from staff and patients", cost, and infections when hair removed within 6 hours versus 18 to 24 hours. |
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Notes | 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: "All patients were randomly allocated" Comment: no description provided of generation of randomisation sequence. |
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 information provided regarding 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 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. |