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

Trials

Anja Dietzel¹  Sylvia Danner¹  Jürgen Hoffmann²  Christof Hofele²  Christian Freudlsperger²  Oliver Ristow²  Philipp Münch²  Johannes Krisam³  Maximilian Pilz³  Christina Klose³ 

[1] Coordination Centre for Clinical Trials (KKS), University of Heidelberg, 69120, Heidelberg, Germany;Department of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany;Institute of Medical Biometry and Informatics, Department of Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, D-69120, Heidelberg, Germany;

关键词: Antibiotic prophylaxis;    Surgical site infection;    Randomised controlled trial;    Orthognathic surgery;   

DOI  :  10.1186/s13063-021-05710-x

来源: Springer

【 摘 要 】

BackgroundIt 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.MethodsThis 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.DiscussionAs 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 registrationDRKS—German Clinical Trials Register—DRKS00022838; EudraCT No. 2020-001397-30. Registered on 29 March 2021

【 授权许可】

CC BY