Radu 2011.
Methods | Country where data collected: Germany Parallel‐group RCT (intra‐individual) Unit of randomisation: burn Unit of analysis: burn Duration: 24 h |
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Participants | Inclusion criteria: aged 18‐80 years with 2nd‐degree partial‐thickness burn > 3% TBSA and at least two 10 cm² symmetrical or similar areas for comparison. Abbreviated Burn severity Index score no higher than 10 Exclusion criteria: NR Participants: 30 people with burns presenting at burn department of trauma centre Mean age (years): median 42 Male participants: 22/30 Burn type: scald 12, contact 7, flame 11 Burn degree: 2nd Burn size (%TBSA): median 18 (range 6‐36) Burn location: trunk 9, thigh 11, lower leg 5, arm 5 |
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Interventions | Intervention arm 1: SSD (Flammazine); gauze Intervention arm 2: octenidine gel, gauze Cointerventions: initial disinfection with Octinisept and removal of blisters; preparation for treatment with synthetic skin substitute |
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Outcomes | Secondary outcome: pain | |
Notes | Funding NR 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: "A prospective, randomized, non‐blinded, clinical study was conducted" Comment: no information on how the randomisation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "The prospective, randomized, clinical study was performed.... . Patients needed to have symmetrical or similar burned areas close to each other for comparability. Burns were randomly selected, one area was treated with Flammazine1/gauze, another area in the same patient was treated with Octenidine‐Gel1/ gauze as initial antiseptic treatment." Comment: no information on whether the treatment allocation was adequately concealed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "the patient was instructed to mark his/her pain on a visual analogue scale". Comment: it was not clear if the participant was blinded. So unclear whether assessment was |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All enrolled participants completed the study." Comment: all randomised participants/burns included in the analysis |
Selective reporting (reporting bias) | Low risk | Quote: "In this study we compared the feasibility and practicability, with focusing on pain scores, time of wound bed preparation and quality of the wound site" Comment: individual patient data were reported for the planned outcomes; a paired analysis is required to analyse these |
Other bias | Unclear risk | Comment: it was unclear whether the analysis took into account the intra‐individual study design |