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. 2017 Jul 12;2017(7):CD011821. doi: 10.1002/14651858.CD011821.pub2

Radu 2011.

Methods Country where data collected: Germany
Parallel‐group RCT (intra‐individual)
Unit of randomisation: burn
Unit of analysis: burn
Duration: 24 h
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
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
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.
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