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

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)
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)
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
Outcomes Primary outcome: wound healing (partial‐thickness burns only)
Primary outcome: infection and septicaemia
Secondary outcome: mortality
Secondary outcome: adverse events
Notes Data extraction and 'Risk of bias' assessment undertaken by translators from Portuguese
Funding unclear
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