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 |