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.
Antibiotic prophylaxis
Orthognathic surgery
Randomised controlled trial
Surgical site infection
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
02 Nov 2021
02 Nov 2021
Historique:
received:
18
04
2021
accepted:
08
10
2021
entrez:
3
11
2021
pubmed:
4
11
2021
medline:
5
11
2021
Statut:
epublish
Résumé
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. 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. 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. DRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
DRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.
Identifiants
pubmed: 34727951
doi: 10.1186/s13063-021-05710-x
pii: 10.1186/s13063-021-05710-x
pmc: PMC8561874
doi:
Substances chimiques
Anti-Bacterial Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
762Subventions
Organisme : Deutsche Forschungsgemeinschaft
ID : RI2813/3-1
Informations de copyright
© 2021. The Author(s).
Références
Lancet Infect Dis. 2014 Aug;14(8):742-750
pubmed: 25022435
Stat Med. 1999 Aug 15;18(15):1905-42
pubmed: 10532877
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Apr;61(4):448-473
pubmed: 29589090
Cochrane Database Syst Rev. 2015 Jan 05;1:CD010266
pubmed: 25561078
Lancet Infect Dis. 2012 May;12(5):357-8
pubmed: 22297079
Stat Methods Med Res. 2007 Jun;16(3):219-42
pubmed: 17621469
N Engl J Med. 2004 Jun 10;350(24):2441-51
pubmed: 15190136
Eur J Oral Sci. 2002 Dec;110(6):425-33
pubmed: 12507215
J Oral Maxillofac Surg. 1985 Apr;43(4):270-6
pubmed: 3856643
Biometrics. 1994 Sep;50(3):859-64
pubmed: 7981407
PLoS One. 2018 Jan 31;13(1):e0191161
pubmed: 29385159
Science. 1999 May 21;284(5418):1318-22
pubmed: 10334980
Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96
pubmed: 10196487
PLoS One. 2013 Nov 11;8(11):e78942
pubmed: 24244390
Curr Control Trials Cardiovasc Med. 2000;1(1):19-21
pubmed: 11714400
Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8
pubmed: 1334988
Stat Med. 1990 Dec;9(12):1447-54
pubmed: 2281232
Clin Trials. 2008;5(3):225-39
pubmed: 18559412
Int J Oral Maxillofac Surg. 2011 Dec;40(12):1363-8
pubmed: 21871782
Community Dent Health. 1994 Mar;11(1):3-11
pubmed: 8193981
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Jun;91(6):643-8
pubmed: 11402275
Clin Plast Surg. 2007 Jul;34(3):331-55
pubmed: 17692696
J Oral Maxillofac Surg. 2017 Apr;75(4):796-804
pubmed: 27789268
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
J Oral Maxillofac Surg. 2011 Oct;69(10):2650-6
pubmed: 21549486
Lancet Infect Dis. 2015 Dec;15(12):1429-37
pubmed: 26482597