Rodgers 1997.
Methods |
Study design: randomised, prospective, partially‐blinded study. Setting/location: hospital (St Christopher's Hospital for Children, Pennsylvania). Country: USA. Period of study: October 1993‐September 1994 (11 months). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: no. Use of ITT analysis?: no. |
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Participants |
Inclusion criteria: 1. Patients admitted for care of burns. 2. Burns < 35% TBSA. 3. Requirement for surgical debridement and grafting. Exclusion criteria: 1. Clinical evidence of infection at the time of debridement. 2. Received antibiotic therapy before debridement. 3. History of allergy to penicillin or cephalosporins. Randomised: 48 patients (42 patients < 35% TBSA; 6 patients > 35% TBSA). One patient with ≥ 35% TBSA burns was re‐entered into the randomisation for a 2nd debridement procedure. Excluded (before randomisation): < 35% TBSA burned: 21 patients (50%); > 35% TBSA burned: 3 patients (50%). Reason for exclusion: Failure to consent: 10 patients < 35% TBSA burned. Receipt of antibiotics before surgical debridement: < 35% TBSA burned: 10 patients, > 35% TBSA burned: 3 patients. Allergy to penicillin: < 35% TBSA burned: 1 patient. Withdrawals: < 35% TBSA burned: Intervention group: 1 (2%). Reasons: became hypotensive and hypothermic during surgery and was not responsive to volume resuscitation. Patients assessed: 24 patients (50%). < 35% TBSA burned: 20 patients (Intervention group: n = 10, Control group: n = 10). > 35% TBSA burned: 4 patients (Intervention group: n = 3, Control group: n = 1). Age (years): (mean): < 35% TBSA: Intervention group: 1.5, Control group: 1.9. > 35% TBSA: Intervention group: 5.4, Control group: 8. Gender (male: female): <35% TBSA: Intervention group: 6 (60%): 4 (40%), Control group: 4 (40%): 6 (60%). >35% TBSA: Intervention group: 3 (100%): 0, Control group: 1 (100%): 0. Burned surface (% TBSA): (mean): <35% TBSA: Intervention group: 10%, Control group: 11%. >35% TBSA: Intervention group: 45%, Control group: 55%. TBSA full thickness burns: > 35% TBSA: Intervention group: 3 (100%), Control group: 1 (100%). Inhalation injury: not stated. Time post‐burn (h): not stated. Burn type: < 35% TBSA: Intervention group: scald (hot liquid or steam) 9 (90%), fire (flame) 1 (10%); Control group: scald 6 (60%), fire 2 (20%), electrical 1 (10%), contact (hot solids) 1 (10%) > 35% TBSA: Intervention group: fire 3 (100%), Control group: fire 1 (100%) Wounds infected at baseline?: no. Co‐morbidity: not described. |
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Interventions |
Type of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative). Type of interventions: cefazolin vs placebo, cefazolin vs targeted antibiotics. < 35% TBSA Intervention group: iv cefazolin 25 mg/kg 6‐hourly for 24 h. Administered in the operating room after a blood culture. Control group: placebo (normal saline in the volume corresponding to the cefazolin dose). > 35% TBSA Intervention group: iv cefazolin 25 mg/kg 6‐hourly for 24 h. Control group: targeted antibiotics in the volume corresponding to the cefazolin dose (selected by the infectious diseases consultant based on the results of the latest surveillance cultures). Duration of intervention: perioperative (1 day). Co‐interventions: surgical debridement of the burn wound . |
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Outcomes | Infection (bacteraemia). Organisms isolated. Burn wound infection (quantitative tissue biopsy cultures). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "After categorization of TBSA burn, patients were randomised to treatment groups with use of a standard random number table" (Page 343 trial report). |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "All antibiotics and placebo were prepared by the hospital pharmacy and administered by one unblinded investigator (GR)" (Page 343). There was not enough information about blinding of participants, although it was reported that the professional who administered the intervention was not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All grafts were inspected by one of two attending plastic surgeons (who were blinded to study treatment assignment) . . . " (Page 343 trial report). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20/21 (95 %) and 4/4 (100%) in the < 35% TBSA group and in the ≥ 35% TBSA group, respectively, were included in the final analysis. |
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 | Low risk | The study appeared to be free of other sources of bias. |