A2B 试验，烧伤患者切除-植皮手术的抗生素预防：一项多中心随机双盲研究。

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

机构信息

Department of Anaesthesiology, Critical Care Medicine and Burn unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 1 Avenue Claude Vellefaux, 75010, Paris, France.

INSERM UMR-S942, Institut National de la Santé et de la Recherche Médicale (INSERM), FHU PROMICE Lariboisière Hospital, Paris, France.

出版信息

Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y.

DOI:10.1186/s13063-020-04894-y

PMID:33239101

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7687822/

Abstract

BACKGROUND

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.

METHODS

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.

DISCUSSION

The trial aims to provide evidence on the efficacy and safety of antibiotic prophylaxis for excision-graft surgery in burn patients.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04292054 . Registered on 2 March 2020.

摘要

背景

在烧伤患者中，抗生素预防的适应证仍然存在很大争议，尚未达成共识。抗生素预防的目的是降低术后局部和全身感染的风险。烧伤手术与菌血症、术后感染和脓毒症的发生率高有关。然而，抗生素预防会使患者面临选择耐药病原体的风险，以及抗生素的不良反应（即艰难梭菌结肠炎）。缺乏数据使得在这种情况下，无法就围手术期使用全身性抗生素预防提出任何强有力的国际建议。因此，本项目的目的是确定围手术期全身抗生素预防是否可以降低烧伤患者术后感染的发生率。

方法

A2B 试验是一项多中心（10 个中心）、前瞻性、随机、双盲、安慰剂对照研究。该试验将招募 506 名成人烧伤患者，烧伤总面积（TBSA）为 5%至 40%，需要至少一次切除植皮手术治疗深度烧伤。参与者将随机分为接受抗生素预防（抗生素预防组）或安慰剂（对照组），在第一次两次手术的切口前 30 分钟。主要结局是术后感染的发生，定义为术后脓毒症和/或手术部位感染和/或移植物溶解，需要在手术后 7 天内进行新的移植物。次要结局包括随机分组后第 90 天的死亡率、需要新的移植手术的皮肤移植物溶解、术后菌血症（术后 48 小时内）、术后脓毒症、术后手术部位感染、完全愈合前的住院次数（>95%TBSA）、第 28 天和第 90 天无抗生素治疗的住院天数、第 28 天和第 90 天的多重耐药细菌定植或感染。