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

APOS 研究 - 预防正颌手术感染并发症的抗生素预防

• 批准号: 426546266
• 负责人: Privatdozent Dr. Oliver Ristow
• 金额: --
• 依托单位: Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/426546266?language=en
• 关键词: APOS; study; Antibiotic; Prophylaxis; preventing

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.

由于仍然缺乏明确的治疗指南，许多外科医生在术后继续使用广谱抗生素，这不仅增加了成本，还增加了抗生素耐药性的可能性。尤其是在正颌外科(OS)中，关于抗生素预防(AP)目前还没有达成共识。因此，迫切需要一项设计合理的前瞻性临床试验，将无术后AP的患者与OS术后有AP的患者进行比较。这项研究提出了一项多中心、随机、对照、双盲的临床试验，有两个平行的研究臂，以证明在接受过OS的患者的手术部位感染(SSI)方面，没有任何术后AP比AP更好。主要疗效终点定义为术后30天内发生SSI。整个试验计划为54个月，39个月内招收1420名患者(最多15个中心)。作为一种高度标准化的手术，在世界各地都有相同的过程，选择性OS为可比的干预组提供了平衡的基线特征和可比的手术时间，即使是在多个中心进行的情况下。因此，OS术后评估AP可能具有很高的科学价值，可用于其他外科手术。