Ilankovan 1992.
Study characteristics | ||
Methods | RCT | |
Participants | 50 people (age 15 to 60) requiring zygomatic arch repair in England. Dates of study not given. | |
Interventions | Group 1: hair removal with a razor (n = 25)
Group 2: no hair removal (n = 25) Product details: no details are given for the razor. Timing of hair removal: after anaesthesia had started. Hair removal carried out by: not specified. Venue for hair removal: the operating table. |
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Outcomes | Primary outcome: participant and surgeon preferences. Participants were asked to assess their appearance (scalp hair removal) immediately after surgery. Surgeons were asked to assess surgical difficulty. Secondary outcome: signs of local infection, including pus in conjunction with erythema associated with tenderness and wound breakdown. Assessed 1 week after surgery, no details as to who conducted the assessment. |
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Notes | Numbers of infections were not reported, though "there was no difference in the incidence of infection between the two groups". No funding sources mentioned. No details on conflict of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised by a random number sequence into two groups" Comment: adequate approach. |
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 | Quote: "Group 1 underwent conventional temporal shaving, while group 2 had no preoperative hair removal" 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 discussion of whether participants were analysed in groups to which they had been allocated. |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Unclear risk | Dropouts were not reported. Comment: insufficient details to permit a judgement. |
Selective reporting (reporting bias) | Low risk | Main outcomes reported. Comment: raw data for study secondary outcome (SSI) are not presented. The author states no difference between groups in SSIs. Unlikely to be affected by reporting bias. |
Other bias | Low risk | Comment: participant groups were equal or similar. |