Grober 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 215 adult men having surgery involving their genitalia in Canada (dates not given). Included vasectomy reversal, penile prosthesis insertion, testis biopsy, orchidectomy, and scrotal skin surgery. | |
Interventions | Group 1: hair removal with clippers (n = 107) Group 2: hair removal with razor (n = 108) Product details: razors were Gillette 2 blade disposable, clippers were 3M surgical clippers. Timing of hair removal: after anaesthesia had commenced. Hair removed by: not specified. Venue for hair removal: the operating department. |
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Outcomes | Primary outcome: effectiveness of method and skin trauma. Photographs taken immediately after hair removal and assessed in a blinded fashion by "groups of urologic surgeons and surgical nursing staff". Secondary outcome: SSIs defined by evidence of increasing cellulitis or pus, or both, within 3 months of surgery, monitored throughout the duration of study. Participants assessed at 1‐ and 3‐month follow‐up visits, no details regarding who performed the assessment. |
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Notes | No funding sources mentioned. Conflict of interest status: none declared. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "subjects were randomised" Comment: method used for random sequence generation not reported. |
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 | High risk | Quote: "Members of the surgical team ... perform the hair removal on the scrotal skin within the surgical field ..." Comment: care providers were involved in hair removal. |
Blinding (performance bias and detection bias) Participants blinded | High risk | Quote: "Participants not blinded" Comment: it is possible that participants were aware of allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "photographs were reviewed in a blinded fashion" Comment: assessors were blinded to intervention. |
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 | Unclear risk | Not reported. Comment: insufficient details to permit a judgement. |
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. |