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. 2015 Oct 7;2015(10):CD010081. doi: 10.1002/14651858.CD010081.pub2

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:
  • local excision and primary closure (PC) ‐ 76 participants, the dropout rate was not stated

  • local excision and primary closure over a 5 x 5 cm gentamicin‐collagen (GC) sponge ‐ 124 participants, the dropout rate was not stated

Outcomes
  1. Wound complications classified as dehiscence, infection, dehiscence and infection, or seroma after 1 week and 3 months

  2. Local recurrence rate at 3 months

  3. Time to complete wound healing

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
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?