Sami 2011.
| Methods | Country where data collected: Pakistan Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 60 days |
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| Participants | Inclusion criteria: partial‐thickness burns involving between 5% and 40% TBSA Exclusion criteria: NR Participants: 50 adults and children with partial‐thickness burns Mean age (years): range 18 months‐50 years) Male participants: 21/50 Burn type: NR Burn degree: second‐degree (partial‐thickness) Burn size (%TBSA): surface area Burn location: NR |
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| Interventions | Intervention arm 1: pure unprocessed, undiluted honey applied once daily, covered with cotton sterilized gauze Intervention arms 2: layer of 1% SSD cream applied once daily Cointerventions: general management including initial debridement and wound excision were the same in both groups The wounds were cleansed with normal saline and thorough debridement done |
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| Outcomes | Primary outcome: wound healing (epithelialisation) Primary outcome: infection (culture positive) Secondary outcome: pain (VAS 1‐10) and time to pain‐free status Secondary outcome: cost per dressing per %TBSA |
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| Notes | Funding: NR | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The cases were divided into two groups randomly by consecutive sampling method, in equal numbers." Comment: no information on how the randomisation sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | Quote: "The cases were divided into two groups randomly by consecutive sampling method, in equal numbers." Comment: no information on whether the allocation sequence was adequately concealed |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "At the time of change of dressing, details regarding the condition of the wound such as signs of infection, condition of the surrounding tissue, discharge, smell, presence of necrotic tissue, and degree of epithilialisation were noted." Comment: unclear if this assessment was performed by personnel/assessors blinded to the allocation: since the interventions clearly differ then it may be unlikely that assessment could be blinded if it was performed by those changing the dressings |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No direct quote but all participants were included in the analysis. |
| Selective reporting (reporting bias) | Unclear risk | The primary and secondary outcomes were not defined in the methods section so it is difficult to assess if all planned outcomes were reported. |
| Other bias | Unclear risk | No evidence of other sources of bias but reporting insufficient to be certain |