Subrahmanyam 1994.
| 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 less than 40% TBSA within 6 h of burn Exclusion criteria: NR Participants: 64 Mean age (years): 25 vs 24.6 (3‐62; 60 aged 21‐30) Male participants: 28 vs 15 Burn type: scald n = 25 vs 18, flame 12 vs 4, contact burn 3 vs 2 Burn degree: NR (partial‐thickness) Burn size (%TBSA): 18.5% vs 19.4% Burn location: NR |
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| Interventions | Intervention arm 1: dry gauze dipped into unprocessed honey and applied to wound, covered with an absorbent dressing that was changed alternate days. Changed more often if signs of infection. N = 40 Intervention arm 2: amniotic membrane ‐ no other details of dressing given, after day 8 dressing was changed on alternate days, changed more often if signs of infection. N = 24 Cointerventions: washed with normal saline |
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| Outcomes | Primary outcome: wound healing | |
| Notes | Funding NR Information about allocation method, allocation concealment, blinding, and standard deviation for mean time to healing provided by study 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 initial treatment, patients were allotted to the two groups at random." Comment: no further information on methods of sequence generation in study report but 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 | Quote: "After initial treatment, patients were allotted to the two groups at random." Comment: no further information on whether allocation was adequately concealed in study report but 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 | Quote: "The following observations were recorded in all patients: leakage of exudate from the dressing, skin reactions, infection and time for wound healing. Pain was assessed during the change of dressing in both groups, by two separate observers." Comment: no indication as to whether the assessments were conducted by observers blinded to treatment allocation, author provided information to Jull et al (Jull 2015) 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 included in analysis (based on table) |
| Selective reporting (reporting bias) | Low risk | Comment: no specific quote but stated outcomes were all reported |
| Other bias | Unclear risk | Quote: "The honey‐impregnated gauze was prepared by dipping sterile gauze in unprocessed and undiluted honey. The gauze was applied to the wound and then covered with an absorbent dressing. These wounds were inspected every 2 days until healed. In contrast the patients treated with amniotic membrane had a first wound inspection on day 8, when the dressing was changed and then every second day until healed." Comment: unclear if differing observation times influenced outcomes |