Piatkowski 2011.
| Methods | Country where data collected: Netherlands Parallel‐group RCT Unit of randomisation: burns Unit of analysis: burns Duration: NR |
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| Participants | Inclusion criteria: second‐degree burns up to 10% TBSA Exclusion criteria: Aged > 18 years; dermatological diseases and/or pre‐existent poly‐neuropathy Participants: 60 outpatients with 72 burns Mean age (years): 46.5 ± 15.6 vs 34 ± 14.2 Male participants: 19 vs 20 Burn type: scald 19 vs 19; contact 8 vs 2; flame 5 vs 7 Burn degree: all second‐degree Burn size (%TBSA): NR (cm² 151.2 ± 109.6 vs 134.7 ± 99) Burn location: hands 2 vs 6; arms 11 vs 13; thorax 2 vs 2; abdomen 4 vs 2; thighs 18 vs 8; feet 1 vs 3 |
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| Interventions | Intervention arm 1: SSD cream (Flammazine) changed daily. N = 30 Intervention arm 2: polyhexanide‐containing bio‐cellulose dressing (Suprasorb X+PHMB) changed every 2nd or 3rd day. N = 30 Cointerventions: |
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| Outcomes | Primary outcome: wound healing Secondary outcome: pain Secondary outcome: costs |
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| 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) | Low risk | Quote: "Suitable patients were assigned to one of the treatment groups, using computer generated randomization." Comment: computer‐generated randomisation |
| Allocation concealment (selection bias) | Unclear risk | Quote: "A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio‐cellulose dressing (group B) compared to a silver‐sulfadiazine cream (group A) in sixty partial‐thickness burn patients." Comment: no information on whether the allocations to treatment were adequately concealed |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Wound healing was documented using standardized digital photographs, which were assessed by two experienced wound specialists, that were blinded for the treatment." Comment: blinded outcome assessment documented although pain assessment probably not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no specific quote but all participants accounted for |
| Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but although all planned outcomes were reported in some cases the data were only presented graphically |
| Other bias | Unclear risk | Comment: there is potential for unit of analysis issues as they analyse 72 wounds on 60 participants and 2 of the participants had more than one treatment. The data were not useful to our analysis. No other sources of bias were identified and methods were well reported |