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Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial

Mujagic, Edin and Zwimpfer, Tibor and Marti, Walter R. and Zwahlen, Marcel and Hoffmann, Henry and Kindler, Christoph and Fux, Christoph and Misteli, Heidi and Iselin, Lukas and Lugli, Andrea Kopp and Nebiker, Christian A. and von Holzen, Urs and Vinzens, Fabrizio and von Strauss, Marco and Reck, Stefan and Kraljević, Marko and Widmer, Andreas F. and Oertli, Daniel and Rosenthal, Rachel and Weber, Walter P.. (2014) Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials, 15. p. 188.

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Abstract

Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis.; In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years.; The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics.; This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.
Faculties and Departments:03 Faculty of Medicine
03 Faculty of Medicine > Bereich Operative Fächer (Klinik)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Operative Fächer (Klinik)
UniBasel Contributors:Zeindler, Jasmin
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BioMed Central
ISSN:1468-6708
e-ISSN:1745-6215
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:05 Oct 2018 14:39
Deposited On:05 Oct 2018 14:39

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