Email updates

Keep up to date with the latest news and content from Trials and BioMed Central.

Open Access Highly Accessed Study protocol

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

Edin Mujagic1, Tibor Zwimpfer1, Walter R Marti2, Marcel Zwahlen3, Henry Hoffmann1, Christoph Kindler4, Christoph Fux5, Heidi Misteli1, Lukas Iselin1, Andrea Kopp Lugli6, Christian A Nebiker1, Urs von Holzen1, Fabrizio Vinzens1, Marco von Strauss2, Stefan Reck2, Marko Kraljević1, Andreas F Widmer7, Daniel Oertli1, Rachel Rosenthal1 and Walter P Weber1*

Author Affiliations

1 Department of General Surgery, University Hospital of Basel, Spitalstrasse 21, 4031 Basel, Switzerland

2 Department of General Surgery, Hospital of Aarau, Tellstrasse, 5000 Aarau, Switzerland

3 Institute of Social and Preventive Medicine, University of Bern, Finkenhubelweg 11, 3012 Bern, Switzerland

4 Department of Anesthesiology, Hospital of Aarau, Tellstrasse 15, 5001 Aarau, Switzerland

5 Department of Infectious Diseases, Hospital of Aarau, Tellstrasse 15, 5001 Aarau, Switzerland

6 Department of Anesthesiology, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

7 Department of Infectious Diseases, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland

For all author emails, please log on.

Trials 2014, 15:188  doi:10.1186/1745-6215-15-188

Published: 24 May 2014

Abstract

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.

Keywords:
Randomized controlled trial; Surgical antimicrobial prophylaxis; Surgical site infection