Subrahmanyam 1998.
Methods | Country where data collected: India Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 30 days |
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Participants | Inclusion criteria: superficial thermal burns less than 40% TBSA within 6 h of burn Exclusion criteria: NR Participants: 50 people attending burns unit Mean age (years): 25.2 vs 26.4 Male participants: 14 vs 13 Burn type: flame 23/22, scalds 2/3, TBSA 14.5%/15.6% Burn degree: NR Burn size (%TBSA): 14.5 vs 15.6 Burn location: NR |
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Interventions | Intervention arm 1: 16 mL‐30 mL unprocessed honey, dry gauze applied on top and covered with bandage; honey changed alternate days Intervention arm 2: SSD impregnated gauze, changed daily Cointerventions: washed with normal saline |
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Outcomes | Primary outcome: wound healing | |
Notes | Funding NR Information about allocation method, allocation concealment, blinding, mean time to healing 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: "After the initial management, patients were allocated at random to two groups." Comment: no indication how the randomisation sequence was generated but study 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: "After the initial management, patients were allocated 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 the wounds healed. The times taken for healing of the wounds were recorded in both groups." Comment: no indication if observers were blinded in study report; 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 the analysis (tables) |
Selective reporting (reporting bias) | Low risk | Comment: no specific quote but the specified outcomes of interest were all reported |
Other bias | Low risk | Comment: no specific quote but there was no evidence of other bias but reporting insufficient to be certain |