Durtschi 1982.

Methods	Study design: prospective, randomised, double‐blind clinical trial. Setting/location: hospital (Regional Burn Center at the University of Washington). Country: USA. Period of study: 1 September 1978‐1 February 1980 (17 months). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: no. Use of ITT analysis?: no.
Participants	Inclusion criteria: 1. Age: ≥ 18 years. 2. Burns ≥ 20% TBSA. 3. All patients hospitalised in Regional Burn Center, University of Washington. Exclusion criteria: 1. Electrical burns. 2. Admission > 48 h after burn injury. 3. Allergy to penicillin. 4. Received antibiotics in previous 30 days. 5. Infection, or suspected infection, of the burn at admission. 6. If burn previously treated with biological dressings. 7. Insulin‐dependent diabetes, a disease requiring steroids or immunosuppressive therapy, massive obesity, severe malnutrition, or malignant disease Randomised: 97 patients. Excluded (post‐randomisation): 46 (47.4%) (reported as withdrawn). Reason for exclusion: Patient discharged before completion of 5‐day course of penicillin or placebo. Additional antibiotics begun for undocumented reason. Inappropriate entry into the study. Additional antibiotics given before excision and grafting. Patients assessed: 51 (52.6%) (Intervention group: 25 (25.7%), Control group: 26 (26.8%)). Age (years): (mean, range): Intervention group: 31.1 (18‐77), Control group: 36.8 (18‐66). Gender (male: female): Intervention group: 20 (80%): 5 (20%), Control group: 24 (92%): 2 (8%). Burned surface (% TBSA): (mean, range): Intervention group: 14.9% (1‐70%), Control group: 20% (1‐91%) TBSA full thickness burns: (mean, SD): not stated. Inhalation injury: not stated. Time post‐burn (h): ≤ 48 h. Burn type: Intervention group: thermal (100%), Control group: thermal (100%). Wounds infected at baseline?: no. Co‐morbidity: not reported.
Interventions	Type of antibiotic prophylaxis: systemic antibiotic prophylaxis (general). Type of interventions: penicillin vs placebo. Intervention group: penicillin V potassium (250 mg), orally 6‐hourly for 5 days, or aqueous penicillin 1.2 million units iv 12‐hourly for 5 days. Control group: oral administration of placebo 6‐hourly for 5 days. The majority received medication or placebo by the oral route. Duration of intervention: 5 days. Co‐interventions: wound cleansing (2 times/day) and topical application of SSD. Patients received no additional antibiotics during initial 5 days of study period. Early tangential excision and grafting were performed when deemed appropriate by attending physician. All patients received clinical care according to the standards of the Burn Center.
Outcomes	Burn wound sepsis: syndrome resulting from presence of > 100,000 organisms/g biopsied wound tissue, associated with variable temperature and leucocyte count, blood chemistry abnormalities, and occasionally accompanied by positive blood cultures. Cellulitis: an area of warm, spreading, cutaneous erythema, accompanied by local pain and fever. Documented infection in lungs or urinary tract. LOS (days).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "After obtaining informed consent, patients were randomised to receive either penicillin or an identical‐appearing placebo" (Page 12 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	Low risk	Quote: " . . . penicillin or an identical‐appearing placebo beginning on the day of admission" (Page 12 trial report). Comment: blinding of participants and personnel probably done.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Because the diagnosis of cellulitis is primarily based on clinical criteria, a placebo group was essential for the study design. The physicians responsible for diagnosing cellulitis knew only that a patient was receiving either penicillin or placebo, but were unaware of the patient assortment". Comment: blinding of outcome assessment probably done.
Incomplete outcome data (attrition bias) All outcomes	High risk	Only 51/97 randomised patients included in the 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	Unclear risk	Insufficient information to assess whether an important risk of bias existed.