Methods |
RCT. Method of randomisation, allocation concealment not reported. Blinding of outcome assessors recorded. Patients served as their own controls (i.e. one area of the same patient was treated with intervention while another similar area was taken as a control) |
Participants |
27 patients (mean age 18.6 years) with second‐degree burns (mean %TBSA: 24.1) |
Interventions |
Antimicrobial release biosynthetic dressing (Hydron) versus once or twice‐daily application of SSD |
Outcomes |
Wound appearance
Number of dressing changes
Need for surgery
Incidence of infection |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Patients acted as own control and 2 sites per patient were selected "at random" for the 2 different therapies |
Allocation concealment (selection bias) |
Unclear risk |
Not reported |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Different care protocols ‐ blinding of patients and investigators very unlikely but assessors were reported as blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No reported withdrawals or dropouts |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
Other bias |
High risk |
(1) Materials for trial provided by pharmaceutical company and no description provided or methods used to prevent bias; (2) patients acted as own control, giving rise to potential unit of analysis errors |