Yang 2013.
| Methods | Country where data collected: China Parallel‐group RCT Unit of randomisation: burn Unit of analysis: burn Duration: 14 days |
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| Participants | Inclusion criteria: total burn < 30% TBSA, deep partial second‐degree burn wounds, > one month treatment; residual wound < 10% TBSA, single wound < 5 cm x 5 cm Exclusion criteria: no general infection or complications Participants: 60 hospital patients each with 2 burns Mean age (years): 39 ± 13 (range 18‐65) Male participants: NR Burn type: NR Burn degree: NR Burn size (%TBSA): NR; size 18 ± 8 cm2 vs 15 ± 10 cm2 Burn location: NR |
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| Interventions | Intervention arm 1: FLAMIGEL (hydrogel dressing) covered with cotton gauze, changed every day to 7 days, then every other day to 14 days. N = 60 burns Intervention arm 2: iodophor gauze covered with cotton gauze, changed every day to 7 days, then every other day to 14 days. N = 60 burns Cointerventions: |
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| Outcomes | Primary outcome: wound healing Secondary outcome: pain |
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| 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 | Quote: “This prospective randomised trial was conducted according to the random number table” Comment: a random component in the sequence generation process was reported |
| 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: no mention of blinding of key study personnel used |
| 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 | Reporting insufficient to determine whether the intra‐individual design was adjusted for or other risks |