Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)

Официальное название

"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"

Обзор

The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis). Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis. The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.

Подробное описание

The intensive care unit investigator will verify the inclusion and non-inclusion criteria.

The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure assessment (SOFA) score, Glasgow Coma scale; Medical history / comorbidities; Concomitant treatment; Burn wound bacterial colonization; Biological parameters.

The inclusion and randomization will be performed as late as possible before the first surgical procedure.

Randomization: Burn patients with deep burn between 5 to 40% TBSA requiring at least one excision surgery graft will be randomized to receive antibioprophylaxis (or placebo) 30 minutes before the incision with either first generation cephalosporin (cefazolin) (if absence of colonization to Pseudomonas aeruginosa); or piperacillin-tazobactam (if the burned area is colonized with Pseudomonas aeruginosa). We chose to target specifically Pseudomonas aeruginosa because it has been associated with significant morbidity and risk of graft lysis in burn patients.

No specific exams are required during the 7 days, 28 days and 90 days follow up visits.

The end of research visit is the 90-day follow-up visit. If the patient has been discharged from the hospital, the 90-day visit will consist of a telephone contact with the patient if he or she has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.

Вмешательства

• Препарат active intervention
  The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.
• Другое placebo intervention
  The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.

Первичные конечные точки

• Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery. [Срок оценки: 7 days after surgery]
• Post-operative sepsis [Срок оценки: 7 days after surgery]
• Surgical site infection [Срок оценки: 7 days after surgery]
• Graft lysis needing a new graft procedure [Срок оценки: 7 days after surgery]

Вторичные конечные точки (8)

• Mortality [Срок оценки: At day 90]
• Skin graft lysis requiring a new graft procedure [Срок оценки: 7 days after surgery]
• Postoperative bacteremia [Срок оценки: within 7 days of surgery]
• Post-operative pulmonary infection [Срок оценки: 7 days after surgery]
• Post-operative surgical site infection [Срок оценки: 7 days after surgery]
• Number of hospitalization days living without antibiotic therapy [Срок оценки: at Day 28 and Day 90]
• Number of days of hospitalization until complete healing (> 95% total burn surface area) [Срок оценки: at Day 28 and Day 90]
• Number of patients with a colonization with a multidrug resistant bacteria. [Срок оценки: at Day 28 and Day 90]

Критерии участия

Критерии включения

• Patient over 18 years and less than 80 years old
• Burned patients requiring at least one excision-graft surgery
• Burn TBSA% between 5% and 40%
• Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)

Критерии исключения

• Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
• History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems).
• Patient on antibiotic therapy at the time of surgery
• Pregnant or breast-feeding patient
• Patient not covered by the social security
• Patient transferred from another burn Unit
• Patient participant in investigational competitive medicinal product study on the primary endpoint
• Patient with local or systemic signs of infection requiring systemic antimicrobial therapy
• Patient under guardianship
• Patient under curatorship
• known colonization of the burned area to be excised with tazocillin-resistant germ.
• obese patient with BMI > 50 kg/m²

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Saint Louis Hospital — Paris

Публикации

• Depret F, Farny B, Jeanne M, Klouche K, Leclerc T, Nouette-Gaulain K, Pantet O, Remerand F, Roquilly A, Rousseau AF, Sztajnic S, Wiramus S, Vicaut E, Legrand M; A2B trial investigators. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y. PMID 33239101

Идентификаторы

NCT: NCT04292054 · APHP180605

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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