| Methods |
RCT with randomisation sequence generated by computer code and allocation concealment achieved by sealed numbered envelopes opened sequentially. No blinding employed. Blinding of participants and investigators (including outcome assessors) not reported. |
| Participants |
64 patients (mean age 20.2 years) with partial thickness burns (mean %TBSA: 2.2%) less than 24 hours old. Chemical and electrical burns, grossly contaminated wounds, wounds more than 24 hours old and wounds treated with topical agents were excluded. |
| Interventions |
Biosynthetic dressing (Biobrane) versus twice‐daily application of SSD |
| Outcomes |
Time to complete wound healing
Level of pain
Incidence of infection |
| Notes |
Withdrawals
I: 7/33 (21.2%)
C: 5/31 (16.1%)
Loss to follow‐up
I: 2/33 (6.1%)
C: 4/31 (13.0%) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated codes |
| Allocation concealment (selection bias) |
Low risk |
"Computer generated codes within sealed numbered envelopes. . . opened in sequential fashion" |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Care protocols were different so blinding of patients and investigators not feasible. Blinding of outcome assessors not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
12/54 (19%) of patients excluded; reasons and group membership reported |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported |
| Other bias |
High risk |
(1) Patients acted as own control, giving rise to potential unit of analysis errors; (2) comparison of groups at baseline only made on groups that completed the study |
