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. 2013 Mar 28;2013(3):CD002106. doi: 10.1002/14651858.CD002106.pub4

Kumar 2004.

Methods RCT. Method of randomisation, allocation concealment and not reported. Described as a non‐blind study.
Participants 33 participants with a total of 58 wound sites. Patients excluded if the burn injury had occurred > 24 hours prior to commencement of treatment, the wounds identified as full thickness in depth or the wounds exhibited signs of infection.
Interventions Comparing the effectiveness of biosynthetic dressings (TransCyte and Biobrane) and SSD
Outcomes Time to complete wound healing 
 Need for surgery 
 Number of dressing changes 
 Narcotic analgesia requirements during dressing change
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients "randomised by lottery" but no further description provided
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Stated as "unblinded"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk It does not appear that there were any withdrawals or dropouts
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias High risk (1) The unit of randomisation in the study was participants but the measurement of most outcomes were according to burn wound, giving rise to unit of analysis errors. 33 participants were randomised to one of three therapies; the 33 participants had 58 burn wounds and outcomes measured changes to wounds; (2) pharmaceutical company support for study with no description of methods used to minimise the likelihood of bias