Subrahmanyam 1993b.
| 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: partial‐thickness burns < 40% TBSA Exclusion criteria: Participants: 92 people attending a general hospital Mean age (years): 42.8 (3‐65) Male participants: 44 Burn type: NR Burn degree: NR (partial‐thickness) Burn size (%TBSA): 22.7 (15‐35) groups 22.8 vs 22.6 Burn location: NR |
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| Interventions | Intervention arm 1: honey‐impregnated gauze prepared by dipping sterile gauze in unprocessed and undiluted honey, covered with pad and bandage, changed on alternate days unless signs of infection Intervention arm 2: bio‐occlusive, moisture‐permeable polyurethane dressing (OpSite) kept in place until day 8 if no sign of infection, leakage etc 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 on allocation method, allocation concealment, blinding, mean TBSA, mean time to healing and standard deviation for mean time to healing provided by author to Jull et al (Jull 2015) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "After initial management, patients were allotted at random to two groups." Comment: no further information on methods of sequence generation; 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 authors was minimal and not sufficient to reassure us that the sequence was truly random |
| Allocation concealment (selection bias) | Unclear risk | Quote: "After initial management, patients 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 not known whether these were opaque |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "In both groups bacterial culture and sensitivity determinations were performed from swabs taken from the surface of the wound.... until the wound healed. The time required for complete healing was noted in both groups." Study author provided a statement to Jull et al that outcome assessors were blinded Comment: despite author information that assessors were blinded, 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 the outcomes cited were subsequently reported |
| Selective reporting (reporting bias) | Low risk | Comment: no specific quote but all randomised participants were included in the analysis (shown in tables) |
| Other bias | Unclear risk | Comment: no specific quote but no evidence of other sources of bias but reporting insufficient to be certain |