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. 2013 Jun 6;2013(6):CD008738. doi: 10.1002/14651858.CD008738.pub2

Alexander 1984.

Methods Study design: prospective, randomised trial.
Setting/location: hospital (Shriners Burns Institute Cincinnati Unit, Ohio). Country: USA.
Period of study: not stated (published in 1984).
Unit of randomisation: patient.
Unit of analysis: patient and procedure.
Sample size calculation: no.
Use of ITT analysis?: yes.
Participants Inclusion criteria:
1. Patients admitted to the Burns Center (acute care).
2. Burns of ≥ 20% of TBSA.
Exclusion criteria:
1. History of sensitivity to multiple antibiotics.
Randomised: 69 patients (Intervention group: n = 35, Control group: n = 34).
Withdrawals: not stated.
Burned surface (% TBSA):
20‐50% TBSA: Intervention group: 19 (54.3%), Control group: 21 (62%).
≥ 50% TBSA: Intervention group: 16 (45.7%), Control group: 13 (38%).
Inhalation injury: not stated.
Time post‐burn (h): not stated.
Burn type: not stated.
Wounds infected at baseline?: no.
Co‐morbidity: not described.
Interventions Type of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative).
Type of interventions: prophylactic antibiotics vs no prophylactic antibiotics.
Intervention group: prophylactic antibiotics during the perioperative period for debridement and skin grafting.
Selection of the antibiotic(s) for use was based upon antibiotic sensitivity of the dominant organism and most recent wound cultures. Antibiotics were not given at other times except for specific medical indications.
Control group: no prophylactic antibiotics.
Duration of intervention: perioperative (1 day).
Co‐interventions: not described.
Outcomes Infection (total number of bacteraemic episodes/days at risk).
Postoperative blood cultures.
Mortality.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomised to receive prophylactic antibiotics or no prophylactic antibiotics within the size ranges of 20‐50 % and greater than 50% to assure equal distribution. Randomization was done at the time of admission and an attempt was made to place all control patients on one ward and all treatment patients on another ward" (Page 20 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 Unclear risk No information provided.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided.
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) High risk No protocol provided. Not all of the outcomes reported were mentioned in the methods section of the paper (for example, mortality was not specified).
Other bias Unclear risk Although mentioned that the groups were homogeneous, no data on age, sex, or comorbidity in each comparison group were presented.