Subrahmanyam 1996b.
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: TBSA burnt < 40% | |
Interventions | Intervention arm 1: pure, unprocessed, undiluted, honey, covered with gauze, changed every 2nd day Intervention arm 2: soframycin (90 participants), Vaseline‐impregnated gauze (90 participants), OpSite (90 participants), sterile gauze (90 participants) or left exposed (90 participants). “Dressings were replaced on alternative days, except in the case of OpSite, which was continued until the wounds healed... sterile linen changed at frequent intervals.” Frequency of dressing change is not mentioned with respect to the sterile gauze group |
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Outcomes | Primary outcome: wound healing | |
Notes | Information about allocation method, allocation concealment, blinding, and standard deviation for mean time to healing provided by author to Jull et al (Jull 2015) Funding NR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “After initial treatment, the cases were divided at random into a study group treated with honey dressing and a control group treated with conventional dressing” Comment: method of generating the random sequence not reported. Study author provided information 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 | Comment: not stated, but study author provided information 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 | Comment: not stated in study report, but study author responded to request for further information from Jull et al by stating the investigators and outcome assessors were blinded. How blinding was achieved was not described in the response and 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 | Appears that all randomised participants were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to determine whether there is a risk of outcomes being selectively reported |
Other bias | Unclear risk | Comment: no specific quote but there was no evidence of other bias but reporting insufficient to be certain |