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Title: Dexamethasone and Surgical-Site Infection
Authors: Corcoran Tomas B
Myles Paul S
Forbes Andrew B
Cheng Allen C
Bach Leon A
O'Loughlin Edmond
Leslie Kate
Chan Matthew TV
Story David
Short Timothy G
Martin Catherine
Coutts Pauline
Ho Kowk M
PADDI Investigators
Australian and New Zealand College of Anaesthetists Clinical Trials Network
Australasian Society for Infectious Diseases Clinical Research Network
Anzca Brief Name: PADDI Investigators
Australasian Society for Infectious Diseases Clinical Research Network
Keywords: Postoperative Nausea and Vomiting
Surgical Wound Infection
Issue Date: 6-May-2021
Source: 384(18):1731-1741
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. less... 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.).
DOI: 10.1056/NEJMoa2028982
PubMed URL:
ISSN: 0028-4793
Journal Title: N Engl J Med
Type: Journal Article
Study/Trial: Case Control Studies
Appears in Collections:Scholarly and Clinical

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