Balthazar 1983.
Study characteristics | ||
Methods | RCT | |
Participants | 200 people having elective inguinal hernia repair in the USA between 1978 and 1981 | |
Interventions | Group 1: preoperative hair removal with a razor (n = 100)
Group 2: preoperative hair removal with clippers (n = 100) Product details: razors were "safety razors" with a wet shave which were washed between cases, the clippers were "ordinary barbers electric clippers". Timing of hair removal: immediately before surgery. Hair removed by: not specified. Venue for hair removal: not reported. |
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Outcomes | Primary outcome: wound infection defined as "discharge of purulent exudate", assessed by infection control nurse daily for 5 days postoperatively and by unspecified practitioners at 2 weeks postoperatively. Secondary outcome: adequacy of hair removal, skin trauma judged by attending surgeon. |
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Notes | All recruited participants were male; no statistical test of significance. 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 randomised using standard table of random numbers" Comment: done. |
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 | It appears that no participants dropped out from the study. Comment: 200 participants reported in the results section. |
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. |