APOS-抗生素预防用于预防正颌手术中的感染性并发症：一项 III 期、多中心、随机、对照、双盲、临床试验的研究方案，有两个平行的研究组。
APOS-antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms.
机构信息
Department of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Coordination Centre for Clinical Trials (KKS), University of Heidelberg, 69120, Heidelberg, Germany.
出版信息
Trials. 2021 Nov 2;22(1):762. doi: 10.1186/s13063-021-05710-x.
BACKGROUND
It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree.
METHODS
This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres.
DISCUSSION
As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures.
TRIAL REGISTRATION
DRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.
背景
外科医生一直在争论是否使用长时间的术后抗生素可以降低手术部位感染率。由于缺乏具体的治疗指南，许多外科医生仍在使用广谱抗生素，这不仅增加了成本，而且还导致了抗生素耐药性的潜在风险。因此，迫切需要进行设计合理的前瞻性临床试验，以调查手术后预防性使用抗生素是否确实可以在临床上降低手术部位感染的发生率。
方法
本研究提出了一项多中心、随机、对照、双盲临床试验，设有两个平行的研究组，以证明在接受正颌手术的患者中，不进行术后抗生素预防（AP）并不逊于抗生素预防在手术部位感染方面。主要疗效终点定义为手术后 30 天内发生的术后手术部位感染。次要终点是手术后 90 天内的进一步疗效和以受试者为导向的参数。整个试验计划持续 54 个月，通过 14 个国家参与中心在 39 个月内招募 1420 名患者。
讨论
作为一种高度标准化的程序，涉及健康、年轻的同质研究人群，且在全球范围内采用相同的流程，正颌手术作为清洁污染手术为可比的干预组提供了均衡的基线特征、可比的手术时间，即使在多个中心进行手术也是如此。因此，评估正颌手术后的抗生素预防将具有很高的科学价值，可代表其他手术程序。
试验注册
DRKS-German Clinical Trials Register-DRKS00022838；EudraCT No. 2020-001397-30。注册于 2021 年 3 月 29 日。
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