Adisa 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 165 people undergoing clean general surgery in Nigeria between August 2007 and July 2008 | |
Interventions | Group 1: removal with a razor (n = 86) Group 2: removal with cream (n = 79) Product details: no details are given for the razor, the cream was Veet. Timing of hair removal: the morning of the operation. Hair removed by: nursing staff. Venue for hair removal: the operating theatre. |
|
Outcomes | Primary outcome: wound infection. Southampton wound infection scoring system used. Secondary outcomes: presence of injury, presence of skin reactions, and adequacy of hair removal. Wounds assessed on days 3, 5, and 7 postoperatively by an independent "senior resident". All participants were followed up for at least 5 weeks. |
|
Notes | No funding sources mentioned. No details of conflict of interest. This paper is an abridged version of an unpublished dissertation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomised into two groups using a balloting method"; "Consecutive patients were asked to pick one of two sealed envelopes containing a folded paper on which one of the two methods was written" Comment: done. |
Allocation concealment (selection bias) | Low risk | Quote: "patients asked to pick one of two sealed envelopes" Comment: done. |
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 | Quote: "wounds were inspected by senior resident who had not participated in the surgery" Comment: probably done. |
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 | 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. |