Panahi 2012.
| Methods | Country where data collected: Iran Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 14 days |
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| Participants | Inclusion criteria: thermal second‐degree burns < 5% TBSA, which occurred in preceding 48 h with no other injuries Exclusion criteria: renal, hepatic, endocrine, cardiovascular or cerebrovascular disease, pregnancy, drug/alcohol abuse and concurrent use of antibiotics, steroids or immunosuppressive drugs Participants: 120 people with burns (setting NR) Mean age (years): 33.6 ± 13.4 vs 37.4 ± 12.7 Male participants: 21 (37.5) vs 25 (45.5) Burn type: hot water, steam 24 (42.9) vs 23 (41.8)/fire 22 (39.3) vs 18 (32.7)/hot liquid 5 (8.9) vs 10 (18.2)/hot object 2 (3.6) vs 3 (5.5)/chemical substance 3 (5.4) vs 1 (1.8) Burn degree: second Burn size (%TBSA): 2.48 ± 1.45 vs 2.38 ± 1.42 Burn location: NR |
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| Interventions | Intervention arm 1: herbal cream (A vera gel, Lavandula stoechas essential oil, Pelargonium roseum essential oil), 5 g for each 10 cm² of burn area applied once daily. Sterile gauze used to cover wound and then bandaged. N = 60 Intervention arm 2: SSD 1% cream. Following cleansing and debridement with antimicrobial solution, 5 g for each 10 cm² of burn area applied once daily. Sterile gauze used to cover wound and then bandaged. N = 60 Cointerventions: cleansing and debridement with antimicrobial solution before randomised treatment period; analgesia |
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| Outcomes | Primary outcome: infection Secondary outcome: pain |
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| Notes | Funding: Baqiyatallah University of Medical Sciences, Iran. Herbal creams were provided by Barij Essence Pharmaceutical Co; 3 authors are described as members of this company | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Participants were randomized in a double‐blind manner” Comment: no further information on method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Quote: “Participants were randomized in a double‐blind manner” Comment: no further information to indicate concealment of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “Patients were evaluated for the severity of pain, frequency of skin dryness and infection” Comment: no information on whether outcome assessors were blinded as to allocation; balance of probabilities based on quote is that assessment was unblinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “From the initial 120 patients…9 were excluded due to study protocol violation…Data from 111 completers (n=56 in the herbal cream and 55 in the SSD group) were included in the final analysis” Comment: reasons for withdrawals were reported ‐ study protocol violation; numbers excluded were not high |
| Selective reporting (reporting bias) | Low risk | Quote: “Patients were evaluated for the severity of pain, frequency of skin dryness and infection” Comment: all stated outcomes of interest were reported |
| Other bias | Low risk | Comment: no direct quotes but no evidence of additional sources of bias but reporting insufficient to be certain |