Oen 2012.
| Methods | Country where data collected: Netherlands Parallel‐group RCT (multicentre) Unit of randomisation: participant Unit of analysis: participant Duration: 21 days; follow‐up to 12 months |
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| Participants | Inclusion criteria: adults (aged > 18 years) with acute facial burns (thermal or electrical injuries involving face including scalp, ears and jaw line); neck included only if facial burn extended into it Exclusion criteria: facial burns < 0.25% TBSA; hospitalised for < 72 h; started with topical treatment before admission; unable to consent Participants: 154 (179 originally randomised) participants from 3 dedicated burns centres Mean age (years): 41.9 ± 16.9 vs 41.3 ± 14.5 Male participants: 64 vs 61 Burn type: scald 4 vs 3; flame 70 vs 60; contact 1 vs 2; electrical 2 vs 4; other 1 vs 7 Burn degree: NR Burn size (%TBSA): median 9.8 (IQR 5.0‐19.4) vs 9.3 (4.5‐17.0); facial 3.0 (2.0‐4.5) vs 3.0 (2.0‐4.5) Burn location: facial |
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| Interventions | Intervention arm 1: SSD 10 mg/g plus cerium nitrate 22 mg/g (Flammacerium) at admission and once daily for 48‐72 h. Wounds were then washed daily with chlorhexidine, rinsed with water and left open. N = 78 Intervention arm 2: SSD 10 mg/g (Flammazine) once daily, covered with plain gauze dressing and a fixation dressing until healed. N = 76 Cointerventions: treatment protocols in clinical practice in Dutch burn centres. Washing with chlorhexidine gluconate (Hibiscrub and rinsing with water) |
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| Outcomes | Primary outcome: wound healing secondary outcome: pain secondary outcome: mortality |
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| Notes | Funding: Dutch Burns Foundation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "To this end, an allocation sequence was developed according to center using mixed randomization (M.N.). Prespecified inequality ranged from two to four, and block sizes varied from four to 11. Randomization sequences were generated with a random numbers table." Comment: an appropriate method was used to generate the randomisation sequence |
| Allocation concealment (selection bias) | Low risk | Quote: "The allocation sequence was concealed from the physician enrolling patients, and subversion was prevented by using nontransparent envelopes." Comment: Does not specifically state sealed envelopes but appears to be appropriate allocation concealment |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "It was not possible to guarantee blinding of the observers to treatment allocation because of the presence and/or involvement in clinical care of most observers. The data analysts (I.O. and M.B.) were blinded." Comment: stated that assessors could not be guaranteed to be blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No specific quote but all randomised participants were accounted for in comprehensive flow diagram. There were 25 post‐randomisation exclusions for clearly documented reasons mostly related to protocol violations. These were balanced between the groups. 4 deaths occurred (3 vs 1) but these participants were included in the analysis |
| Selective reporting (reporting bias) | Low risk | Quote: "Primary outcomes were number of patients requiring surgical intervention and time to complete wound healing......Secondary outcomes consisted of wound colonization, pain, and aesthetic and functional aspects." Comment: all specified outcomes were fully reported |
| Other bias | Low risk | Comment: no specific quote but no other sources of bias identified and good level of reporting |