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Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial.

dc.rights.licenseopenen_US
dc.contributor.authorFUTIER, Emmanuel
dc.contributor.authorJABER, Samir
dc.contributor.authorGAROT, Matthias
dc.contributor.authorVIGNAUD, Marie
dc.contributor.authorPANIS, Yves
dc.contributor.authorSLIM, Karem
dc.contributor.authorLUCET, Jean-Christophe
dc.contributor.authorLEBUFFE, Gilles
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorOUATTARA, Alexandre
dc.contributor.authorEL AMINE, Younes
dc.contributor.authorCOUDERC, Philippe
dc.contributor.authorDUPRÉ, Aurélien
dc.contributor.authorDE JONG, Audrey
dc.contributor.authorLASOCKI, Sigismond
dc.contributor.authorLEONE, Marc
dc.contributor.authorPOTTECHER, Julien
dc.contributor.authorPEREIRA, Bruno
dc.contributor.authorPAUGAM-BURTZ, Catherine
dc.date.accessioned2023-01-09T15:04:50Z
dc.date.available2023-01-09T15:04:50Z
dc.date.issued2022-11-03
dc.identifier.issn1756-1833en_US
dc.description.abstractEnTo investigate whether oral antimicrobial prophylaxis as an adjunct to intravenous antibiotic prophylaxis reduces surgical site infections after elective colorectal surgery. Multicentre, randomised, double blind, placebo controlled trial. 11 university and non-university hospitals in France between 25 May 2016 and 8 August 2019. 926 adults scheduled for elective colorectal surgery. Patients were randomised to receive either a single 1 g dose of ornidazole (n=463) or placebo (n=463) orally 12 hours before surgery, in addition to intravenous antimicrobial prophylaxis before surgical incision. The primary outcome was the proportion of patients with surgical site infection within 30 days after surgery. Secondary outcomes included individual types of surgical site infections and major postoperative complications (Clavien-Dindo classification grade 3 or higher) within 30 days after surgery. Of the 960 patients who were enrolled, 926 (96%) were included in the analysis. The mean age of participants was 63 years and 554 (60%) were men. Surgical site infection within 30 days after surgery occurred in 60 of 463 patients (13%) in the oral prophylaxis group and 100 of 463 (22%) in the placebo group (absolute difference -8.6%, 95% confidence interval -13.5% to -3.8%; relative risk 0.60, 95% confidence interval 0.45 to 0.80). The proportion of patients with deep infections was 4.8% in the oral prophylaxis group and 8.0% in the placebo group (absolute difference -3.2%, 95% confidence interval -6.4% to -0.1%). The proportion of patients with organ space infections was 5.0% in the oral prophylaxis group and 8.4% in the placebo group (absolute difference -3.4%, -6.7% to -0.2%). Major postoperative complications occurred in 9.1% patients in the oral prophylaxis group and 13.6% in the placebo group (absolute difference -4.5%, -8.6% to -0.5%). Among adults undergoing elective colorectal surgery, the addition of a single 1 g dose of ornidazole compared with placebo before surgery significantly reduced surgical site infections. ClinicalTrials.gov NCT02618720.
dc.language.isoENen_US
dc.subject.enAdult
dc.subject.enMale
dc.subject.enHumans
dc.subject.enMiddle Aged
dc.subject.enFemale
dc.subject.enSurgical Wound Infection
dc.subject.enColorectal Surgery
dc.subject.enOrnidazole
dc.subject.enAntibiotic Prophylaxis
dc.subject.enAnti-Bacterial Agents
dc.subject.enAnti-Infective Agents
dc.subject.enDouble-Blind Method
dc.title.enEffect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial.
dc.title.alternativeBMJen_US
dc.typeArticle de revueen_US
dc.subject.halSciences du Vivant [q-bio]/Médecine humaine et pathologieen_US
dc.identifier.pubmed36328372en_US
bordeaux.journalBMJ - British Medical Journalen_US
bordeaux.pagee071476en_US
bordeaux.volume379en_US
bordeaux.hal.laboratoriesBiologie des maladies cardiovasculaires (BMC) - UMR 1034en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcepubmed
hal.exportfalse
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
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