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. 2017 Jul 12;2017(7):CD011821. doi: 10.1002/14651858.CD011821.pub2

Sami 2011.

Methods Country where data collected: Pakistan
Parallel‐group RCT
Unit of randomisation: participant
Unit of analysis: participant
Duration: 60 days
Participants Inclusion criteria: partial‐thickness burns involving between 5% and 40% TBSA
Exclusion criteria: NR
Participants: 50 adults and children with partial‐thickness burns
Mean age (years): range 18 months‐50 years)
Male participants: 21/50
Burn type: NR
Burn degree: second‐degree (partial‐thickness)
Burn size (%TBSA): surface area
Burn location: NR
Interventions Intervention arm 1: pure unprocessed, undiluted honey applied once daily, covered with cotton sterilized gauze
Intervention arms 2: layer of 1% SSD cream applied once daily
Cointerventions: general management including initial debridement and wound excision were the same in both groups The wounds were cleansed with normal saline and thorough debridement done
Outcomes Primary outcome: wound healing (epithelialisation)
Primary outcome: infection (culture positive)
Secondary outcome: pain (VAS 1‐10) and time to pain‐free status
Secondary outcome: cost per dressing per %TBSA
Notes Funding: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The cases were divided into two groups randomly by consecutive sampling method, in equal numbers."
Comment: no information on how the randomisation sequence was generated
Allocation concealment (selection bias) Unclear risk Quote: "The cases were divided into two groups randomly by consecutive sampling method, in equal numbers."
Comment: no information on whether the allocation sequence was adequately concealed
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "At the time of change of dressing, details regarding the condition of the wound such as signs of infection, condition of the surrounding tissue, discharge, smell, presence of necrotic tissue, and degree of epithilialisation were noted."
Comment: unclear if this assessment was performed by personnel/assessors blinded to the allocation: since the interventions clearly differ then it may be unlikely that assessment could be blinded if it was performed by those changing the dressings
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No direct quote but all participants were included in the analysis.
Selective reporting (reporting bias) Unclear risk The primary and secondary outcomes were not defined in the methods section so it is difficult to assess if all planned outcomes were reported.
Other bias Unclear risk No evidence of other sources of bias but reporting insufficient to be certain