Subrahmanyam 2001.
| 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: less than 40% TBSA burn, hospitalised within 6 h post‐burn Exclusion criteria: Participants: 100 people attending burns unit Mean age (years): 26.5 ± 1 vs 25.2 ± 2 Male participants: 52 Burn type: NR Burn degree: NR Burn size (%TBSA): 22.5 ± 3 vs 23.4 ± 1; full‐thickness 3.2 +/‐2 vs 4.7 +/‐1% Burn location: NR |
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| Interventions | Intervention arm 1: 15 mL‐30 mL unprocessed honey, dry gauze applied on top and covered with bandage, changed every 2 days. N = 50 Intervention arm 2: SSD impregnated gauze changed every 2 days. N = 50 Cointerventions: washed with normal saline |
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| Outcomes | Primary outcome: wound healing Primary outcome: infection (resolution) Secondary outcome: resource use (hospital stay) |
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| Notes | Funding NR Information about allocation method, allocation concealment, blinding, and standard deviation for mean time to healing provided by 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: "The patients were allotted at random to two groups," Comment: no indication how the randomisation sequence was generated but author provided information to Jull et al 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: "The patients were allotted at random to two groups," Comment: no indication in study report whether the allocation was adequately concealed. Study author provided information to Jull et al that allocation concealment was by means of sequentially‐numbered sealed envelopes, although it is not clear whether the envelopes were opaque |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The wounds were observed for evidence of infection, excessive exudate, or leakage until they healed." Comment: no indication that observers were blinded to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Thus, in all the patients in this group, the wounds healed by day 21..... In the group treated with sulphur sulphadiazine, the wounds healed in 4 patients by day 7, in 22 patients by 14 day, and in 24 patients by day 21 (mean, 17.2 days)." Comment: it is clear that all participants randomised to the honey group were included in the analysis but not that all of those in the SSD group were, although no attrition is reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but it was not clear which outcomes the authors planned to assess and therefore whether they were all reported fully |
| Other bias | Low risk | Comment: no specific quote but no evidence of other bias |