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

Han 1989.

Methods Country where data collected: UK
Parallel‐group RCT
Unit of randomisation: participant
Unit of analysis: participant
Duration: NR
Participants Inclusion criteria: people attending ED with partial skin thickness burns
Exclusion criteria: pregnancy, steroid or immunosuppressive therapy, diabetes, antibiotic therapy, iodine allergy; burns with more than 6 h between injury and admission, facial and perineal burns, burns > 10% TBSA; infected burns
Participants: 213 people attending ED
Mean age (years): NR; proportion children < 12 years 20.5 vs 20.7; detailed age breakdown also reported
Male participants: NR distribution equal between groups; female:male ratio 1:1 vs 1.1.2
Burn type: steam/hot liquid 67 vs 80; flame/fumes 14 vs 10; hot object 15 vs 12; other 6 vs 9
Burn degree: NR
Burn size (%TBSA): Mean NR. < 1%, 73 vs 87; 1%‐2%, 21 vs 15; 2%‐3%, 4 vs 4; 3%‐4%, 3 vs 3; 4%‐5%, 0 vs 2; > 5% 1 vs 0
Burn location: trunk and neck 11 vs 14; shoulder and proximal arms 5 vs 6; elbow and forearm 21 vs 19; wrists and hands 38 vs 42; thigh, knee and lower leg 19 vs 14; ankle and foot 8 vs 16
Interventions Intervention arm 1: 0.5% chlorhexidine acetate BP (N = 102)
Intervention arm 2: lnadine (rayon dressing with 10% povidone iodine ointment) (n = III) as required; application of cold soaks using refrigerated sterile water/saline; cleansed with Hibidil (0.25 per cent chlorhexidine gluconate in sterile aqueous solution). Blisters deroofed only if large and tense. Dressings covered with gauze and crepe bandage. Upper limb injuries were elevated in a sling.
Outcomes Primary outcome: infection (bacterial culture positive and clinical evidence)
Secondary outcome: pain
Secondary outcome: resource use (hospital visits)
Notes Funding NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A total of 213 patients who attended the Accident and Emergency Department, Royal Victoria Infirmary, Newcastle upon Tyne with partial skin thickness bums were entered into a prospective randomized (random permuted block allocation) single blind trial."
Comment: insufficient information on how the randomisation sequence was derived.
Allocation concealment (selection bias) Unclear risk Quote: "A total of 213 patients who attended the Accident and Emergency Department, Royal Victoria Infirmary, Newcastle upon Tyne with partial skin thickness bums were entered into a prospective randomized (random permuted block allocation) single blind trial."
Comment: no information on whether the allocation was adequately concealed
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "All patients were reviewed in the clinic 3 days later in the first instance and subsequently every 5 days. A data sheet was prepared for each patient and data recorded during the change of dressing according to a predetermined grading system relating to the description of the wound and/or dressings and clinical parameters".
Comment: no information on whether outcome assessors were blinded to treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no specific quote but no information on whether all patients were involved in most analyses; children were specifically excluded from assessment of pain and a total of 24% of participants were not included for this outcome
Selective reporting (reporting bias) High risk Quote: "Mean scores for pain and wound characteristics were calculated for each patient."
Comment: it was not clear whether these (and dressing performance) were planned as the only assessed outcomes; the outcomes that they planned to assess appear to be listed on the datasheet (fig 1) ‐ this includes healing, which is not properly reported (e.g. "there were no differences in the other parameters")
Other bias Unclear risk Comment: no specific quote, no evidence of other sources of bias but reporting insufficient to be certain