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

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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.