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

• Published in: Current controlled trials in cardiovascular medicine Vol. 21; no. 1; p. 973
• Main Authors: Dépret, François, Farny, Boris, Jeanne, Mathieu, Klouche, Kada, Leclerc, Thomas, Nouette-Gaulain, Karine, Pantet, Olivier, Rémerand, Francis, Roquilly, Antoine, Rousseau, Anne-Françoise, Sztajnic, Simon, Wiramus, Sandrine, Vicaut, Eric, Legrand, Matthieu
• Format: Journal Article Web Resource
• Language: English
• Published: England BioMed Central Ltd 25-11-2020; BioMed Central
• Subjects: Adult; Anesthesia & intensive care; Anesthésie & soins intensifs; Anti-Bacterial Agents - therapeutic use; Antibiotic Prophylaxis; Antibiotics; Bacterial infections; Burns - drug therapy; Burns - surgery; Burns and scalds; Care and treatment; Complications and side effects; Disease prevention; Double-Blind Method; Double-blind studies; Drug dosages; Drug resistance; Hospitalization; Human health and pathology; Human health sciences; Humans; Infection; Infectious diseases; Informed consent; Intensive care; Life Sciences; Mortality; Multicenter Studies as Topic; Patient outcomes; Patients; Pharmaceutical sciences; Pharmacology; Prevention; Prospective Studies; Randomized Controlled Trials as Topic; Sciences de la santé humaine; Sepsis; Skin; Study Protocol; Surgery; Surgical site infections; Surgical Wound Infection - drug therapy; Surgical Wound Infection - prevention & control; United Kingdom; Antibiotic prophylaxis; Burn; Excision-graft
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04894-y

The indication for antibiotic prophylaxis in burn patients remains highly controversial, with no consensus having been reached. The objective of antibiotic prophylaxis is to reduce the risk of postoperative local and systemic infections. Burn surgery is associated with a high incidence of bacteremia, postoperative infections, and sepsis. However, antibiotic prophylaxis exposes patients to the risk of selecting drug-resistant pathogens as well as to the adverse effects of antibiotics (i.e., Clostridium difficile colitis). The lack of data precludes any strong international recommendations regarding perioperative prophylaxis using systemic antibiotics in this setting. The goal of this project is therefore to determine whether perioperative systemic antibiotic prophylaxis can reduce the incidence of postoperative infections in burn patients.
The A2B trial is a multicenter (10 centers), prospective, randomized, double-blinded, placebo-controlled study. The trial will involve the recruitment of 506 adult burn patients with a total body surface area (TBSA) burn of between 5 and 40% and requiring at least one excision-graft surgery for deep burn injury. Participants will be randomized to receive antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30 min before the incision of the first two surgeries. The primary outcome will be the occurrence of postoperative infections defined as postoperative sepsis and/or surgical site infection and/or graft lysis requiring a new graft within 7 days after surgery. Secondary outcomes will include mortality at day 90 postrandomization, skin graft lysis requiring a new graft procedure, postoperative bacteremia (within 48 h of surgery), postoperative sepsis, postoperative surgical site infection, number of hospitalizations until complete healing (> 95% TBSA), number of hospitalization days living without antibiotic therapy at day 28 and day 90, and multiresistant bacterial colonization or infection at day 28 and day 90.
The trial aims to provide evidence on the efficacy and safety of antibiotic prophylaxis for excision-graft surgery in burn patients.
ClinicalTrials.gov NCT04292054 . Registered on 2 March 2020.