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

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 b...

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Autores principales:	Oliver Ristow, Christof Hofele, Philipp Münch, Sylvia Danner, Anja Dietzel, Johannes Krisam, Christina Klose, Maximilian Pilz, Jürgen Hoffmann, Christian Freudlsperger
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Antibiotic prophylaxis Surgical site infection Randomised controlled trial Orthognathic surgery Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/a04625fe23c64e2ead377e98b95bdcf5
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spelling	oai:doaj.org-article:a04625fe23c64e2ead377e98b95bdcf52021-11-08T11:03:08ZAPOS—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 arms10.1186/s13063-021-05710-x1745-6215https://doaj.org/article/a04625fe23c64e2ead377e98b95bdcf52021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05710-xhttps://doaj.org/toc/1745-6215Abstract 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 2021Oliver RistowChristof HofelePhilipp MünchSylvia DannerAnja DietzelJohannes KrisamChristina KloseMaximilian PilzJürgen HoffmannChristian FreudlspergerBMCarticleAntibiotic prophylaxisSurgical site infectionRandomised controlled trialOrthognathic surgeryMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-15 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Antibiotic prophylaxis Surgical site infection Randomised controlled trial Orthognathic surgery Medicine (General) R5-920
spellingShingle	Antibiotic prophylaxis Surgical site infection Randomised controlled trial Orthognathic surgery Medicine (General) R5-920 Oliver Ristow Christof Hofele Philipp Münch Sylvia Danner Anja Dietzel Johannes Krisam Christina Klose Maximilian Pilz Jürgen Hoffmann Christian Freudlsperger 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
description	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
format	article
author	Oliver Ristow Christof Hofele Philipp Münch Sylvia Danner Anja Dietzel Johannes Krisam Christina Klose Maximilian Pilz Jürgen Hoffmann Christian Freudlsperger
author_facet	Oliver Ristow Christof Hofele Philipp Münch Sylvia Danner Anja Dietzel Johannes Krisam Christina Klose Maximilian Pilz Jürgen Hoffmann Christian Freudlsperger
author_sort	Oliver Ristow
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/a04625fe23c64e2ead377e98b95bdcf5
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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

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