Zhou 2011.
| Methods | Country where data collected: China Parallel‐group RCT (intra‐individual) Unit of randomisation: burn Unit of analysis: burn Duration: 14 days |
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| Participants | Inclusion criteria: paediatric superficial second‐degree burn wounds within 24 h Exclusion criteria: prior treatment; other disease Participants: 40 children with burns divided into 2 areas for treatment Mean age (years): 4.5 ± 2.2 (2‐6) Male participants: 22/40 Burn type: NR Burn degree: second‐degree Burn size (%TBSA): 3.85 ± 1.27 (3‐5) Burn location: neck or front trunk |
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| Interventions | Intervention arm 1: Aquacel‐Ag, covered by 20 layers gauze; took off the outer layer at Day 3; changed new dressing at Day 7 with debridement Intervention arm 2: SD‐Ag, covered by 20 layers gauze; took off the outer layer at Day 3; changed new dressing at Day 7 with debridement Cointerventions: cleaned the wound with water; 5% chlorhexidine acetate for 2 min then cleaned with water again |
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| Outcomes | Primary outcome: wound healing | |
| Notes | Funding NR Article in Chinese, extracted and assessed for risk of bias by one review author, discussed with a second review author This was a "split‐body" or "intra‐individual" design where a person with two wounds had one wound randomised to each treatment. It was not clear whether the analysis took account of this. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: a random component in the sequence generation process was not reported in detail |
| Allocation concealment (selection bias) | Unclear risk | Comment: it did not state how randomisation sequence was allocated |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: results section and tables show that all participant data were included in analysis |
| Selective reporting (reporting bias) | Low risk | Comment: protocol not obtained, based on paper only |
| Other bias | Unclear risk | Note: the abstract stated that “two burn wound areas of similar size were selected from each patient”; in main text, it showed that these two burn areas actually was one wound, just divided to two same‐sized parts; this increases the chance of "carry‐over" from one test site to another. It was unclear whether the analysis adjusted for this intra‐individual design. |
AE: adverse event(s); AEO: Arnebia euchroma ointment; ALT amino alanine transferase; AST: aspartate amino transferase; A vera: Aloe vera; ED: Emergency Department; ITT: intention‐to‐treat; IV: intravenous; NR: not reported; SSD: silver sulfadiazine; TBSA: total body surface area; VAS: visual analogue scale;