1. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study
- Author
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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, and Legrand, Matthieu
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Sepsis ,Clinical Trials and Supportive Activities ,Clinical Research ,Antimicrobial Resistance ,Patient Safety ,Physical Injury - Accidents and Adverse Effects ,Prevention ,Hematology ,6.4 Surgery ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Adult ,Anti-Bacterial Agents ,Antibiotic Prophylaxis ,Burns ,Double-Blind Method ,Humans ,Multicenter Studies as Topic ,Prospective Studies ,Randomized Controlled Trials as Topic ,Surgical Wound Infection ,Burn ,Antibiotic prophylaxis ,Excision-graft ,A2B trial investigators ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
BackgroundThe 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.MethodsThe 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.DiscussionThe trial aims to provide evidence on the efficacy and safety of antibiotic prophylaxis for excision-graft surgery in burn patients.Trial registrationClinicalTrials.gov NCT04292054 . Registered on 2 March 2020.
- Published
- 2020