Suvera 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 215 adults having general surgery in India between April 2010 and March 2012 | |
Interventions | Group 1: hair removal with a razor (112 participants) Group 2: hair removal with depilatory cream (103 participants) Product details: no details are given for the razor, the cream consisted of potassium thioglycolate. Timing of hair removal: on the day of operation. Hair removed by: nursing staff. Venue for hair removal: not reported. |
|
Outcomes | Primary outcome: adequacy of method, skin trauma. Skin was assessed preoperatively by a surgical resident and postoperatively by a senior resident on days 3, 5, and 7. Secondary outcome: SSIs were recorded using a "modification of the Southampton scoring system". All participants were followed up for at least 6 weeks. No further details provided. |
|
Notes | Sources of support: none. Conflict of interest: none declared. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "consecutive patients were asked to pick one of two sealed envelopes ... on which one of the two methods was written" Comment: randomised. |
Allocation concealment (selection bias) | Low risk | Quote: "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: allocation concealed. |
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 | Staff who assessed wounds did not participate in the surgery and were unaware of participants' group allocation status. Comment: outcome assessors were blinded. |
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 | 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 | Unclear risk | Comment: no information on the similarity of groups. |