Buimer 2008.
Methods | This was a 2‐arm, parallel group RCT of wound healing method after local excision and primary closure of active HS lesions | |
Participants | The trial included 200 participants with a clinical diagnosis of HS and symptomatic lesion(s), "i.e. those with discharge, inflammation, infiltration, or suspected abscesses" | |
Interventions | 2 groups, randomised to the following:
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Outcomes |
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Notes | The authors stated in the paper that there was no significant commercial sponsor involvement We were unable to contact the authors to clarify risks of bias and other study details |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The paper gave no details on the random sequence generation; however, the study report stated that there was an imbalance in randomisation due to early cessation of the study. The report did not mention whether the randomisation was intended to be in a 1:1 ratio, so we could not quantify the degree of imbalance in randomisation (76 primary closures, 124 gentamicin sponges inserted) |
Allocation concealment (selection bias) | Unclear risk | The paper provided no details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were blinded under general anaesthetic but postoperatively may have been able to detect the sponge inserted in the wound. There was no description of any special measures to ensure blinding of personnel, who would otherwise have been aware of treatment allocation from the operation notes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The paper provided no details |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The paper provided no details, including no participant flow diagram |
Selective reporting (reporting bias) | Unclear risk | There was no mention of prospective registration |
Other bias | Unclear risk | It was unclear whether participants or surgical procedures were the unit of randomisation, i.e., was more than 1 procedure performed in any individuals? |