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

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اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • Contributors:
      Génétique, Reproduction et Développement (GReD); Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA); CHU Estaing Clermont-Ferrand; CHU Clermont-Ferrand; Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp); Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM); Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Hôpital Claude Huriez Lille; Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Université de Lille-Université de Lille; Service de Gastroentérologie Hôpital Beaujon; Hôpital Beaujon AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord; CIC Hôpital Bichat; AP-HP - Hôpital Bichat - Claude Bernard Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-UFR de Médecine; Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases; Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Centre Hospitalier Universitaire de Bordeaux (CHU de Bordeaux); Centre hospitalier Valenciennes, Nord; Centre hospitalier de Pau; Application des ultrasons à la thérapie (LabTAU); Centre Léon Bérard Lyon -Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM); Département cancer environnement (Centre Léon Bérard - Lyon); Centre Léon Bérard Lyon; Centre Hospitalier Universitaire d'Angers (CHU Angers); PRES Université Nantes Angers Le Mans (UNAM); Service Anesthésie et Réanimation Hôpital Nord - APHM; Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Nord CHU - APHM; Hôpital de Hautepierre Strasbourg; Unité de Biostatistiques CHU Clermont-Ferrand; Direction de la recherche clinique et de l’innovation CHU Clermont-Ferrand (DRCI); CHU Clermont-Ferrand-CHU Clermont-Ferrand; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
    • بيانات النشر:
      HAL CCSD
      BMJ
    • الموضوع:
      2022
    • Collection:
      Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe)
    • نبذة مختصرة :
      International audience ; Objective. To investigate whether oral antimicrobial prophylaxis as an adjunct to intravenous antibiotic prophylaxis reduces surgical site infections after elective colorectal surgery. Design: multicentre, randomised, double blind, placebo controlled trial.Setting: 11 university and non-university hospitals in France between 25 May 2016 and 8 August 2019. Participants: 926 adults scheduled for elective colorectal surgery. Intervention: 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. Main outcome measures: 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. Results. 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%). Conclusion: among adults undergoing elective colorectal surgery, the addition of ...
    • Relation:
      hal-03839446; https://hal.science/hal-03839446; https://hal.science/hal-03839446/document; https://hal.science/hal-03839446/file/2022%20Futier%20et%20al.,%20Effect%20of%20oral.pdf
    • الرقم المعرف:
      10.1136/bmj-2022-071476
    • Rights:
      http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.AFCC22D1