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

Nasiri 2016.

Methods Country where data collected: Iran
Intra‐individual RCT
Unit of randomisation: burn
Unit of analysis: burn
Duration: 30 days
Participants Inclusion criteria: aged 16–65 years, diagnosed by the same expert emergency burn physician based on the presentation of two same sites of second‐degree burns. The burn should have occurred within 24 h before the beginning of treatment, second‐degree burn on 2 sides of the same person's body, and with < 15% TBSA
Exclusion criteria: People with epilepsy, diabetes, immunodeficiency disease, electrical and chemical burns, known allergy and sensitivity to either AEO or SSD, or pregnant women were excluded from the study
Participants: 49 randomised; 45 analysed
Mean age (years): 39.9 (SD 15.6)
Male participants: NR but "most participants were women"
Burn type: scalds 30; flame 14; contact 1 (analysed participants only)
Burn degree: second‐degree
Burn size (%TBSA): 3.7 (SD 2.4; range 1‐13) (analysed participants only)
Burn location: 44% involved lower limbs (analysed participants only)
Interventions Intervention arm 1: Arnebia euchroma ointment (AEO)
Intervention arms 2: SSD
Cointerventions: after admission and primary preparation, the wounds were washed with normal saline or sterile water and dried with sterile gases
Outcomes Primary outcome: proportion of wounds healed at day 13 and mean time to wound healing (re‐epithelialisation)
Primary outcome: signs of clinical infection rated on 6‐point scale from 0 = absent to 5 = all components present
Secondary outcome: adverse events defined as erythema, edema, infection, inflammation, and general wound appearance
Secondary outcome: pain and itching during first 15 minutes of dressing change measured using a 10‐point VAS
Notes Funding: grant (118‐92) from Mazandaran University of Medical Sciences, Sari, Iran
This was a "split‐body" or "intra‐individual" design where a person with two wounds had one wound randomised to each treatment. It was not clear whether the analysis took account of this.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "These areas were randomly assigned to AEO treatment and the opposite site was treated with conventional treatment with SSD cream. A simple coin‐based randomization was performed for each patient after enrolment by the blinded staff nurse."
Comment: the randomisation sequence was generated by an acceptable method
Allocation concealment (selection bias) Unclear risk Quote: "These areas were randomly assigned to AEO treatment and the opposite site was treated with conventional treatment with SSD cream. A simple coin‐based randomization was performed for each patient after enrolment by the blinded staff nurse."
Comment: not clear whether the allocation sequence was adequately concealed
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The general condition of the wound areas were first observed and evaluated by the expert emergency burn physician and the Burn unit special nurse prior to utilization of topical agents. Thereafter, before each dressing, the wounds were assessed by same team who were unaware of the assigned treatment to each side and the ointment applied on the wounds for treatment."
Comment: appears that outcome assessment was performed by individuals blinded to treatment allocation and separate from those applying dressings
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "a total of 51 eligible patients were registered. Forty‐nine of them signed the consent form and were randomly allocated sequentially to the two sides and two treatment groups. Four patients were lost to follow up. Therefore, 45 patient's results were eligible for data analysis..... In addition, 1 patient in both groups needed bilateral skin graft on the day of 11th according to the plastic surgeon's decision. Furthermore, 2 patients in the SSD group needed skin graft from days 11–14, but their treatment area on the opposite area with AEO healed after 5 and 7 days, respectively"
Comment: of the 49 randomised participants 4 were not included in the analysis; each participant was lost from both groups equally; all other participants' data were included in the analysis for each group
Selective reporting (reporting bias) Unclear risk Comment: the outcomes to be assessed were not defined in the methods section so it is not clear whether all planned outcomes were fully reported
Other bias Unclear risk Comment: there is no evidence of additional sources of bias; it is not clear whether the paired data were accounted for in the analysis