Malik 2010.
Methods | Country where data collected: Pakistan Parallel‐group RCT (intra‐individual) Unit of randomisation: burn Unit of analysis: burn Duration: NR |
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Participants | Inclusion criteria: partial‐thickness burns in 2 different parts of the body (same site, e.g. right and left abdomen) occurred within 24 h of treatment initiation. TBSA < 40% Exclusion criteria: diabetes, pregnancy, immunodeficiency, kidney diseases; electrical and chemical burns Participants: 150 hospital patients Mean age (years): 28 ± 16 Male participants: 67/150 Burn type: NR Burn degree: NR Burn size (%TBSA): 22.7 ± 8.5 (10‐38) Burn location: NR but same site/equivalent) |
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Interventions | Intervention arm 1: honey applied directly to wound twice daily; dressing changed twice daily Intervention arm 2: SSD applied daily Cointerventions: fluid resuscitation, oral nutrition, occasional IV infusion of amino acids and blood products |
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Outcomes | Primary outcome: wound healing Primary outcome: infection |
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Notes | Funding: NR 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: “Each patient had one burn site treated with honey and one treated with topical SSD, randomly” Comment: no further information on method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Quote: “Each patient had one burn site treated with honey and one treated with topical SSD, randomly” Comment: no further information to indicate concealment of allocation |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “wound was observed clinically for signs of infection, size, and rate and nature of epithelialization by an expert surgeon…. Patients and nursing staff were blinded to the procedure” Comment: nursing staff were blinded but unsure whether the inspecting surgeon was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “150 patients were enrolled in this study” Comment: no withdrawals reported and Table 10 suggests that all participants were accounted for |
Selective reporting (reporting bias) | Low risk | Quote: “rate of burn wound healing” Comment: all stated outcomes of interest were reported |
Other bias | Unclear risk | Comment: it was unclear whether the analysis took account of the intra‐individual design of the study |