Desai 1991.

Methods	Study design: randomised clinical trial. Setting/location: hospital (Shriners Burns Institute Galveston and the University of Texas). Country: USA. Period of study: not stated (published in 1991). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: no. Use of ITT analysis?: yes.
Participants	Inclusion criteria: 1. Age: ≥ 5 years (able to respond to tactile stimulation and to communicate feelings of discomfort verbally). 2. Patients with burns resulting from traffic accidents. 3. Admitted within 72 h of burn injury. Exclusion criteria: not stated. Randomised: 15 patients (Group 1: n = 7, Group 2: n = 8). Patients assessed: 15 (100%). Withdrawals: not stated. Age (years): (mean): Group 1: 11.4 ± 1.2, Group 2: 9.5 ± 1.6. Burned surface (% TBSA): (mean): Group 1: 35% ± 7, Group 2: 50% ± 6. TBSA full thickness burns: (mean): Group 1: 20% ± 9, Group 2: 32% ± 7. Inhalation injury: not stated. Ventilator support: not stated. Time post‐burn (h): ≤ 72 h. Burn type: Group 1: fire (flame) 100%, Group 2: fire 100%. Wounds infected at baseline?: no. Co‐morbidity: not stated.
Interventions	Type of antibiotic prophylaxis: topical antibiotic prophylaxis. Type of interventions: gentamicin iontophoresis vs routine care. Group 1: gentamicin 1% cream (tube 30 g) layered over the ear, which was covered with the iontophoresis (treatment electrode) for 15‐20 minutes, 2 times/day. Group 2: routine care (6‐hourly ear cleaning and dressing changes). Duration of intervention: until final closure of the ear wound. Co‐interventions: all patients bathed once a day and had their ears cleaned and dressed with mafenide acetate cream 6‐hourly.
Outcomes	Wound infection (defined as chondritis, destruction of unburned cartilage, and ear deformities). Resistant organisms (qualitative cultures, quantitative cultures). LOS (days).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Subjects were randomly assigned to receive gentamicin iontophoresis . . . or to receive routine care alone" (Page 522 trial report). Comment: insufficient information to make a judgement.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and study personnel not reported, but probably not done due to the different nature of the interventions evaluated (cream given by iontophoresis versus routine care).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding of outcome assessment not reported, but probably not done due to the different nature of the interventions evaluated (cream given by iontophoresis versus routine care).
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Did not report number of withdrawals. Comment: denominator values suggested complete follow‐up.
Selective reporting (reporting bias)	Low risk	No protocol provided, but given the outcomes listed in the methods section, all pre‐specified outcomes were reported.
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias existed.