Domes 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 65 men having surgery on male genitalia. Country in which study was conducted and dates of the study are not given. | |
Interventions | Group 1: preoperative hair removal with a razor (n = 28) Group 2: preoperative hair removal with clippers (n = 37) Product details: no details are given on the razor or the clippers. Timing of hair removal: not reported. Hair removed by: not reported. Venue for hair removal: not reported. |
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Outcomes | Primary outcome: skin trauma and shave quality. Photographs taken immediately after hair removal and assessed in a blinded fashion by 5 surgeons and 15 nurses. Secondary outcome: surgical site infection. Definition not given. Assessed at 3 months, no details regarding who conducted assessment. |
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Notes | Abstract from poster presentation. 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 "Patients were randomised" 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 | Low risk | Assessors were blinded. Comment: blinded assessment undertaken . |
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 | High risk | Dropouts for SSI were not reported, but group sizes appeared unequal. Comment: participants were not evenly distributed across groups. |
Selective reporting (reporting bias) | Low risk | Main outcomes reported. Comment: unlikely to be affected by reporting bias. |
Other bias | Unclear risk | Comment: no information on the similarity of groups. |