The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study

Table 1 SPIRIT schematic schedule of enrollment, interventions, and assessments

	Inclusion	Before the surgical procedure(s)^a	First 7 days after surgery surgical procedures	Day 28	Day 90 after first surgery
Informed consent (if not given at the previous visits) (according to law L1122-1-3 of the PHC/Order No. 2016–800 of June 16, 2016—art. 2)	X		X^(b)		X^(b)
Inclusion and non-inclusion criteria	X
Randomization	X
Medical history/comorbidities	X		X		X^d
Antibiotic prophylaxis or placebo		X
Postoperative infections			X		X^d
Pictures of the burn area/surgical site		X	X		X^d
Concomitant treatment	X	X	X		X^d
Clinical^(c) examination/	X^(c)		X^(c)		X^d
Skin bacterial colonization	X	X	X	X	X^d
Glasgow coma score	X	X	X		X^d
Assessment of SOFA score	X	X	X
Retrieval of adverse events	X		X	X	X^d
Beta HCG dosage	X	X
Antibiotic prophylaxis or placebo		X
Assessment of morbidity and mortality			X		X^d
Assessment of primary endpoint		X
Assessment of secondary endpoints			x	x	X^d
Vital status				X^e	X^e

^aThe Beta HCG dosage will be performed before the first surgery, in the case of the second surgery if necessary and before the administration of the treatment (placebo or antibiotic)
^(b)If not done at the previous visits (according to law L1122-1-2 of the PHC)
^(c)Clinical examination:
- Hemodynamic parameters:
Systolic, mean and diastolic arterial pressure, heart rate
- Biological parameters:
Arterial plasma lactate level, plasma pH and base excess, PaO2 and PaO2/FiO2, PaCO2, blood urea nitrogen, serum creatinine, serum potassium level, hemoglobin, total bilirubin level, and platelet count
^dIf the patient is still hospitalized
^eIf the patient has been discharged from the hospital

ISSN: 1745-6215