Subrahmanyam 1991.
| Methods | Country where data collected: India Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: NR |
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| Participants | Inclusion criteria: superficial thermal burns < 40% TBSA Exclusion criteria: NR Participants: 104 participants attending burns unit Mean age (years): 28.5 (3.2) vs 26.7 (4.1) (information provided by author to Jull et al (Jull 2015). (range 1‐65 years) Male participants: 82/104 (42 vs 40) Burn type: thermal Burn degree: NR (superficial) Burn size (%TBSA): mean NR. most participants had 21%‐30% or 30%‐40%; mean 26.5 vs 27.2 Burn location: NR |
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| Interventions | Intervention arm 1: 15 mL‐30 mL honey applied directly to wound, covered with gauze and bandaged, changed daily. N = 52 Intervention arm 2: SSD soaked gauze that was changed daily. N = 52 Cointerventions: washed with normal saline |
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| Outcomes | Primary outcome: wound healing Secondary outcomes: pain and selected AE reported qualitatively |
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| Notes | Funding NR. Information on allocation method, allocation concealment, blinding, mean TBSA, mean time to healing and standard deviation for mean time to healing were provided by the author to Jull et al. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “the cases were allotted at random to two groups” Comment: no further information to indicate how randomisation sequence was generated. Study author information that the sequence was generated by the "chit method", which is a method of drawing lots however the detail provided by the study authors was minimal and not sufficient to reassure us that the sequence was truly random |
| Allocation concealment (selection bias) | Unclear risk | Quote: “the cases were allotted at random to two groups” Comment: study author provided information to Jull et al that allocation concealment was by means of sequentially‐numbered, sealed envelopes but envelopes may not have been opaque |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "In both groups culture and sensitivity determinations were performed on swabs taken from the surface at the time of admission. This was repeated on days 7 and 21 in all cases or untIl the wound healed. The time required for complete healing was noted in both groups." Comment: information provided by the author to Jull et al stated that outcomes assessors were blinded but data analysts were not. So still unclear. Additionally honey is known to cause discolouration of periwound skin making blinded outcome assessment very difficult. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no specific quote but all randomised participants were included in the analysis (shown in tables) |
| Selective reporting (reporting bias) | Unclear risk | No specific quote but although the stated outcomes were all reported some were reported only qualitatively |
| Other bias | Unclear risk | Comment: no specific quote but no evidence of other sources of bias, but reporting insufficient to be certain |