Dexamethasone and Surgical-Site Infection.

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  • Additional Information
    • Corporate Authors:
    • Source:
      Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE
    • Publication Information:
      Original Publication: Boston, Massachusetts Medical Society.
    • Subject Terms:
    • Abstract:
      Background: The glucocorticoid dexamethasone prevents nausea and vomiting after surgery, but there is concern that it may increase the risk of surgical-site infection.
      Methods: In this pragmatic, international, noninferiority trial, we randomly assigned 8880 adult patients who were undergoing nonurgent, noncardiac surgery of at least 2 hours' duration, with a skin incision length longer than 5 cm and a postoperative overnight hospital stay, to receive 8 mg of intravenous dexamethasone or matching placebo while under anesthesia. Randomization was stratified according to diabetes status and trial center. The primary outcome was surgical-site infection within 30 days after surgery. The prespecified noninferiority margin was 2.0 percentage points.
      Results: A total of 8725 participants were included in the modified intention-to-treat population (4372 in the dexamethasone group and 4353 in the placebo group), of whom 13.2% (576 in the dexamethasone group and 572 in the placebo group) had diabetes mellitus. Of the 8678 patients included in the primary analysis, surgical-site infection occurred in 8.1% (354 of 4350 patients) assigned to dexamethasone and in 9.1% (394 of 4328) assigned to placebo (risk difference adjusted for diabetes status, -0.9 percentage points; 95.6% confidence interval [CI], -2.1 to 0.3; P<0.001 for noninferiority). The results for superficial, deep, and organ-space surgical-site infections and in patients with diabetes were similar to those of the primary analysis. Postoperative nausea and vomiting in the first 24 hours after surgery occurred in 42.2% of patients in the dexamethasone group and in 53.9% in the placebo group (risk ratio, 0.78; 95% CI, 0.75 to 0.82). Hyperglycemic events in patients without diabetes occurred in 22 of 3787 (0.6%) in the dexamethasone group and in 6 of 3776 (0.2%) in the placebo group.
      Conclusions: Dexamethasone was noninferior to placebo with respect to the incidence of surgical-site infection within 30 days after nonurgent, noncardiac surgery. (Funded by the Australian National Health and Medical Research Council and others; PADDI Australian New Zealand Clinical Trials Registry number, ACTRN12614001226695.).
      (Copyright © 2021 Massachusetts Medical Society.)
    • Grant Information:
      1079501 National Health and Medical Research Council; GRF 14101816 University Research Committee, University of Hong Kong
    • Contributed Indexing:
      Investigator: T Corcoran; PS Myles; A Cheng; L Bach; KM Ho; MTV Chan; KL Ao; TG Short; A Forbes; D Story; E O'Loughlin; J Sidhu; P Coutts; M Williams; R Browning; E Hamilton; P Boan; P Ingram; A Meehan; C Frampton; B Venkatesh; R Macisaac; M Paech; L Worth; K Goulding; G Ormond; C Martin; S Heritier; S Wallace; R Han; A Ditoro; M Ueoka; A Neylan; P Peyton; G Claxton; S Baulch; S Harris; S Sidiropoulos; G Henderson; K Liyanapathirana; A Mitchell; S Whykes; L Kolarik; A Iliov; A Marriott; L Brennan; M Formica; R Fiddes; E Moore; A Bullingham; J Marshall; T Sara; V Wilkinson; S Chew; L Machado; A Barton; JS Toh; A Grossi; K Barton; L Ren; J Kim; B Correia; T Krantis; R Martin; B Troy; R Bulach; L Bulfin; A Wang; D Bhatia-Dwivedi; T Maggio; N Tan; D McCallum; A Dalyell; V Gordon; M Bailey; L Glazov; A Trehern; V Finlay; J Koerber; A Badenoch; S Rattigan; C Daniel; L Sung; B Moran; A Tandel; M Keehan; A Quail; R Scott; J Douglas; N McDonnell; D Cavill; D Bartlett; G Wright; A Tait; T Hess; A Chuan; L Macdonald; R Rengasamy; B El-Behesy; A Skiller; A Wu; L O'Halloran; J Hiller; B Riedel; K Yee; E Crone; K Coleman; S McKeown; M Bennett; S Cai; A Holmewood; P Marneros; P Sivalingam; D Highton; A Kearney; H Hassan; N Bakri; M Campher; M Duroux; M Ratcliffe; S Hillyard; K Bickell; S Thomas; T Painter; J Somfleth; C Osborn; J Hayer; L de Prinse; J Lee; H Reynolds; M Clarris; S Holz; C Town; B Piper; M Lyon; C Gaylard; N Terblanche; M Challis; R Seale; K Button; S Hannon; K Leslie; R Cotter; C Edgley; D Middleton; B Olesnicky; M Doane; C Player; A Toner; R Way; S March; T McCulloch; G Wong; K Kramer; K Connell; D Ellyard; D Currigan; P Mickle; H Jones; LD Paxton; C Mitchell; R Ray; D McIntyre; V Ward; Y Buller; N Hird; T Phan; J Luxford; P Corcoran; E Fitzgerald; E Gartner; N Beauchamp; G Godsall; S Wadham; H Rodgers; D Nithyanandam; D Babu; A Singh Nanuan; A Singh Sarai; P Correa; I Lemech; C Jenkins; E Hessian; D Bramley; N Sheridan; K Gill; A Tippett; S Bates; R Halliwell; N Phillips; F Ali; L Cope; E Clark-Mackay; R Paranthioene; NA Smith; F Rouhani; WKK Wu; B Fung; E Lee; K Hui; C Lam; B Cheng; M Misur; D McAllister; S Dandy; L Ritchie; S McGuinness; R Parke; J Dalton; M Butler; RR Kennedy; MA McKellow; R Fuchs; R Gray; F Gilmour; S Walker; H Houston; S Olliff; B Biccard; M Flint
    • Molecular Sequence:
      ANZCTR ACTRN12614001226695
    • Accession Number:
      0 (Antiemetics)
      0 (Glucocorticoids)
      7S5I7G3JQL (Dexamethasone)
    • Publication Date:
      Date Created: 20210505 Date Completed: 20210517 Latest Revision: 20210517
    • Publication Date:
      20231215
    • Accession Number:
      10.1056/NEJMoa2028982
    • Accession Number:
      33951362