Alexander 1983.
Study characteristics | ||
Methods | RCT | |
Participants | 1013 people having elective, clean surgery in the USA between July 1979 and July 1981. Includes vascular, thoracic, abdominal, gynaecological, and neurosurgical. | |
Interventions | Group 1: clipping day before surgery (n = 249)
Group 2: clipping on the morning of surgery (n = 226)
Group 3: shaving with a razor the day before surgery (n = 271)
Group 4: shaving with a razor on the morning of surgery (n = 266) Product details: no details are given for the razor or the clippers. Timing of hair removal: either the day of surgery or the day before surgery according to randomisation. Hair removed by: not specified. Venue for hair removal: not reported. |
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Outcomes | Primary outcome: wound infection defined as "discharge of pus"; assessed by a research nurse at discharge and with follow‐up 30 days after discharge. Secondary outcomes: length of stay and cost. |
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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) | Low risk | Quote: "Patients were randomised by draw of a card from a sealed envelope" Comment: random sequence generation not described in adequate detail. |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised by draw of a card from a sealed envelope" Comment: done |
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 have been 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 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. |