Methods |
RCT with randomisation technique and allocation concealment described. Blinding of participants and investigators (including outcome assessors) not reported. |
Participants |
14 patients (mean age 41 years) with partial thickness burns (mean %TBSA: 14.6) |
Interventions |
Silver‐impregnated dressing (Acticoat) versus SSD application and removal twice daily |
Outcomes |
Level of pain
Incidence of infection |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Random drawing of sealed envelopes from a box" |
Allocation concealment (selection bias) |
Low risk |
"Sealed envelopes" in a box ‐ not possible for personnel to guess assignment |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Different care protocols so blinding of participants and investigators not feasible ‐ not mentioned if assessors blinded |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
4 of 14 patients were excluded because their burns did not meet eligibility criteria, 6 more patients dropped out (5 because of more pain with control treatment), leaving 4/14 patients remaining in the study. This is likely to cause significant bias because the primary outcome was a comparison of pain scores. |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported, although not possible to measure healing times because of difficulties in the study. Adverse events also measured. |
Other bias |
Unclear risk |
Patients acted as own control, giving rise to potential unit of analysis errors |