Abstract
Abstract
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
Funder
Deutsche Forschungsgemeinschaft
Ruprecht-Karls-Universität Heidelberg
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference37 articles.
1. Van Boeckel TP, Gandra S, Ashok A, Caudron Q, Grenfell BT, Levin SA, et al. Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. Lancet Infect Dis. 2014;14(8):742–50.
2. Hedrick TL, Sawyer RG. The end of postoperative antimicrobial prophylaxis? Lancet Infect Dis. 2012;12(5):357–8.
3. Wacha H, Hoyme U, Isenmann R, Kujath P, Lebert C, Naber K, et al. Perioperative Antibiotika-Prophylaxe. Empfehlung einer Expertenkomission der Paul-Ehrlich Gesellschaft für Chemotherapie e.V. Chemother J. 2010;19(3):70–84.
4. Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Cordova Jara L, Villanueva J. Antibiotic prophylaxis for preventing infectious complications in orthognathic surgery. Cochrane Database Syst Rev. 2015;1:CD010266.
5. Aiken AM, Wanyoro AK, Mwangi J, Juma F, Mugoya IK, Scott JA. Changing use of surgical antibiotic prophylaxis in Thika Hospital, Kenya: a quality improvement intervention with an interrupted time series design. PLoS One. 2013;8(11):e78942.
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