Subrahmanyam 1996a.
| Methods | Country where data collected: India Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 21 days |
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| Participants | Inclusion criteria: partial‐thickness burns < 40% TBSA, presenting within 6 h of injury Exclusion criteria: NR Participants: 100 Mean age (years): 28.2 vs 27.5 (range age 5‐59 years) Male participants: 29 vs 28 Burn type: scald n = 17 vs 15, flame 23 vs 22, contact 7 vs 12, explosives 2 vs 1, chemical 1 vs 0 Burn degree: NR (partial‐thickness) Burn size (%TBSA): 16.5 vs 17.2% (range 10‐40) Burn location: NR |
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| Interventions | Intervention arm 1: 15 mL to 30 mL undiluted and unprocessed honey, dry gauze applied on top and covered with bandage, inspected on alternate days. N = 50 Intervention arm 2: autoclaved potato‐peel dressing, dry gauze and bandage applied, changed alternate days or earlier if signs of infection, or excessive exudate or leakage. N = 50 Cointerventions: washed with normal saline |
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| Outcomes | Primary outcome: wound healing Primary outcome: infection |
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| Notes | Funding NR Information about allocation method, allocation concealment, blinding, and standard deviation for mean time to healing provided by study author to Jull et al (Jull 2015) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "After the initial management, patients were allotted at random to two groups." Comment: no indication how the randomisation sequence was generated. Study author provided information to Jull et al (Jull 2015) that the sequence was generated by the "chit method", which is a method of drawing lots however the information provided was minimal and lacked detail to sufficiently reassure us that the method was truly random |
| Allocation concealment (selection bias) | Unclear risk | Quote: "After the initial management, patients were allotted at random to two groups." Comment: no further information on whether allocation was adequately concealed in study report but study author provided information to Jull et al that allocation concealment was by means of sequentially‐numbered, sealed envelopes but not known whether these were opaque |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The wounds were inspected every 2 days until healed." Comment: no indication as to whether outcome was determined by a blinded observer in study report; study author provided information to Jull et al that outcome assessors were blinded but honey is known to cause discolouration of periwound skin making blinded outcome assessment very difficult; therefore judgement unclear |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no specific quote but all randomised participants were included in analysis (tables) |
| Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but outcomes cited in methods were all reported |
| Other bias | Unclear risk | No specific quote but no evidence of other sources of bias but reporting insufficient to be certain |