Huang 2004.
Methods | Parallell, RCT in four centres throughout China. Method of randomisation, allocation concealment and blinding of participants and investigators (including outcome assessors) not reported. | |
Participants | 98 participants (male 79; female 19) aged 18 to 65 years with 166 residual burn wounds (mean %TBSA: 54). Average time since burn was 36 days. Exclusion criteria included serious complications of the heart, liver, kidney or blood system; serious infection; shock; pregnancy or lactation; allergy to sliver ions; diabetic ulceration with associated poor diabetic control; acute metabolic disorder. | |
Interventions | Nanocrystalline silver dressing (Acticoat) versus silver sulphadiazine (SD‐Ag 1%). Daily topical application of SD‐Ag 1% if the wound was severe (secretion; redness; swelling) or every three days if wound not severe | |
Outcomes | Time to complete wound healing
Incidence of infection Adverse events |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The observing doctor hands out the dressing to every patient according to the time that they come to the hospital and to a randomized serial number". It is not clear how time of presentation influenced which treatment group participants were assigned to |
Allocation concealment (selection bias) | High risk | There is a risk of selection bias: doctor treating the patients allocated dressing |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label treatment protocol The study describes assessment of the wound by two doctors, but it is not clear whether they were aware of treatment group assignment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 13 participants were withdrawn from the study. The distribution of missing data was not described between the two groups. The analysis of healing time does not take account of the withdrawals; data from participants whose wounds had failed to heal are censored |
Selective reporting (reporting bias) | Unclear risk | Safety outcomes not reported. Efficacy outcomes were reported, but the authors report no difference in adverse events between groups: no numerical data presented. |
Other bias | High risk | Patients (n = 98) randomised into groups but outcomes mostly measured effects on wounds (n = 166); unit of analysis errors. Not clear how the wounds distributed in the randomised patients. |