Khorasani 2009.
Methods | Country where data collected: Iran RCT with intra‐individual design Unit of randomisation: burn Unit of analysis: burn Duration: 24 days |
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Participants | Inclusion criteria: 2 comparable second‐degree ("same site") burns e.g. on hands or feet with similar areas Exclusion criteria: electrical or chemical burns, diabetes, pregnancy, immunodeficiency, kidney disease Participants: 30 participants with 2 comparable burns Mean age (years): 33 (± 11) Male participants: 25/30 Burn type: NR Burn degree: 2nd degree Burn size (%TBSA): 19.8 ± 7.9 Burn location: 26 burns on right and left hand, 2 on right and left foot, 2 on right or left hand |
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Interventions | Intervention arm 1: 0.5% A vera cream produced from powder applied twice daily. 30 burns Intervention arm 2: SSD (concentration not explicitly stated) applied twice daily. 30 burns Cointerventions: wound cleaning with water and saline; dressings; fluid resuscitation; "other treatment protocols"; oral nutrition; occasional amino acid infusions; blood products |
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Outcomes | Primary outcome: wound healing Primary outcome: infection |
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Notes | Funding: Mazandaran University, 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) | Unclear risk | Quote: “Each patient had one burn treated with topical SSD and one treated with aloe cream, randomly.” Comment: no further details on randomisation method |
Allocation concealment (selection bias) | Unclear risk | Quote: “Each patient had one burn treated with topical SSD and one treated with aloe cream, randomly.” Comment: no further details on allocation |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: ”At the time of each dressing, the wound was observed clinically for signs of infection, size, and rate and nature of epithelialization by an expert surgeon. In this study, the “B” part of the body was treated with SSD and the “A” part was treated with aloe cream. Patients and nursing staff were blinded to the procedure.” Comment: no mention of blinding of the surgeon/assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Finally, 30 patients were enrolled in this study.” Comment: 30 participants included in outcome reporting |
Selective reporting (reporting bias) | Unclear risk | “At the time of each dressing, the wound was observed clinically for signs of infection, size, and rate and nature of epithelialization by an expert surgeon.” Comment: results of visual infection checks not reported (though the study does report on microbial swab contamination) |
Other bias | Unclear risk | Comment: unclear whether analysis took into account the intra‐individual design |