De Gracia 2001.
Methods | Country where data collected: Phillipines Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: NR (until healing of partial‐thickness burns and readiness for skin grafting in full‐thickness burns) |
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Participants | Inclusion criteria: aged > 4 months with TBSA > 15%, admitted within 24 h of burn injury Exclusion criteria: inhalation injury, known hypersensitivity to sulfonamides, known methemoglobinemia during the pre‐burn period Participants: 60 participants with moderate or severe burns Mean age (years): 30 (11.5) vs 24 (14.6) Male participants: 16/30 vs 20/30 Burn type: NR Burn degree: partial and full‐thickness Burn size (%TBSA): partial‐thickness 22% vs 30%; full‐thickness 5.6% vs 2.1% Burn location: face, perineum, trunk, extremities (proportions not reported) |
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Interventions | Intervention arm 1: SSD (Flammazine) changed 2‐3 times daily for open dressings on face or perineum; daily on trunk and extremities (closed dressings) Intervention arm 2: SSD plus cerium nitrate (Flammacerium) changed 2‐3 times daily for open dressings on face or perineum; daily on trunk and extremities (closed dressings) Cointerventions: fluid and electrolyte resuscitation, wound cleansing with skin cleanser soap and water or normal saline |
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Outcomes | Primary outcome: wound healing (partial‐thickness burns only) Primary outcome: infection and septicaemia Secondary outcome: mortality Secondary outcome: adverse events |
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Notes | Data extraction and 'Risk of bias' assessment undertaken by translators from Portuguese Funding unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "20 patients.... were assigned consecutively to receive either SSD‐CN or SSD alone, according to a pre‐established randomized sequence" Comment: no information on how randomisation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "20 patients.... were assigned consecutively to receive either SSD‐CN or SSD alone, according to a pre‐established randomized sequence" Comment: no information on whether allocation was concealed adequately |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The gross appearance of the burn wound was noted in all patients...... overall responses to therapy were rated in terms of wound bacterial count and time for epithelialization of partial thickness wounds or readiness of full thickness burns to accept skin grafts". Comment: no indication whether outcome assessment was performed in a blinded fashion |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss |
Selective reporting (reporting bias) | Low risk | All proposed outcomes were reported. |
Other bias | Unclear risk | It is not clear if the groups were similar regarding relevant characteristics at baseline |