Zahmatkesh 2015.
| Methods | Country where data collected: Iran Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 20 days |
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| Participants | Inclusion criteria: participants with second‐degree burns (depth 0.2‐5.0 mm) up to 40% TBSA; aged 15‐55, referred during first 24 h following injury, negative culture on admission Exclusion criteria: participants with underlying conditions such as diabetes, chronic renal or hepatic diseases, and those with simultaneous burns, trauma, and skin lacerations were excluded Participants: 30 individuals with superficial or deep partial‐thickness burns Mean age (years): 24.8 (11.9) Male participants: 21/30 Burn type: direct fire or oil: 26 Burn degree: partial‐thickness burns; deep partial‐thickness 6/10 vs 11/20 Burn size (%TBSA): surface area Burn location: NR |
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| Interventions | Intervention arm 1: olea ointment which contains 33.4% honey, 33.3% olive oil, and 33.3% sesame oil. After washing the wound with normal saline solution, 3–5 mm thick layer of Olea ointment was applied over the wound and closed dressing was performed every day Intervention arms 2: 1.5 mm‑thick layer of acetate mafenide ointment (8.5%) every 12 h, Cointerventions: debridement as required |
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| Outcomes | Primary outcome: wound healing (development of granulation tissue) Primary outcome: infection (development of positive culture after 7 days) Secondary outcome: adverse events: need for surgical debridement |
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| Notes | Funding: Kurdistan University of Medical Sciences | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "30 available patients .....who were divided into two groups using simple randomized method and table of random numbers" Comment: table of random numbers used to generate randomisation sequence |
| Allocation concealment (selection bias) | Unclear risk | Quote: "30 available patients .....who were divided into two groups using simple randomized method and table of random numbers" Comment: unclear whether allocation sequence was adequately concealed |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the microbiologist and pathologist were blinded to the treatment groups. To assess the outcomes, the burn wounds were evaluated daily after a week of intervention by a pathologist and a microbiologist for the formation of granulation tissues, debridement (using scalpel), and wound culture results" Comment: blinded outcome assessment for all outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "If they had positive culture, they were excluded from the study and treated by routine treatment for bacterial strains. However, the excluded patients were entered in the analysis." Comment: all participants appear to be included in the analysis |
| Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but not clear that all the outcomes assessed were specified in the methods |
| Other bias | Low risk | Comment: does not appear to be any additional source of bias |