Nasiri 2016.
Methods | Country where data collected: Iran Intra‐individual RCT Unit of randomisation: burn Unit of analysis: burn Duration: 30 days |
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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) |
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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 |
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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 |
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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. |
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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 |