APOS study- Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery

由于仍然缺乏明确的治疗指南，许多外科医生继续使用术后广谱抗生素，不仅增加了成本，而且还导致了抗生素耐药性的可能性。特别是在正颌外科（OS），目前还没有关于抗生素预防（AP）的共识。因此，迫切需要一个适当设计的前瞻性临床试验，比较术后无AP的患者和OS术后AP的患者。本研究提供了一个多中心，随机，对照，双盲，两个平行研究组的临床试验，以证明无术后AP在手术部位感染（SSI）方面不劣于AP主要疗效终点定义为手术后30天内发生的术后SSI。整个试验计划为期54个月，39个月内入组1420例患者（最多15个中心）。作为一种高度标准化的手术，在世界各地采用相同的过程，择期OS提供了具有平衡基线特征、可比手术持续时间的可比干预组，即使在多个中心进行。因此，OS后AP的评估可能具有很高的科学价值，可代表其他外科手术。

As definitive treatment guidelines are still lacking, many surgeons continue to use postoperative broadspectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Especially in orthognathic surgery (OS) there is no current consensus regarding antibiotic prophylaxis (AP). Hence, there is an urgent need for an appropriately designed prospective clinical trial, comparing patients without postoperative AP to patients with postoperative AP after OS. This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative AP is not inferior to AP with respect to surgical site infections (SSI) in patients having undergone OS. The primary efficacy endpoint is defined as the occurrence of postoperative SSI within 30 days of surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients within 39 months (up to 15 centres). As a highly standardised procedure with identical processes all over the world, elective OS provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating AP after OS might be of high scientific value representable for other surgical procedures.