title: Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.
authors.forename: Edin
authors.initials: E
authors.lastname: Mujagic
authors.forename: Tibor
authors.initials: T
authors.lastname: Zwimpfer
authors.forename: Walter R
authors.initials: WR
authors.lastname: Marti
authors.forename: Marcel
authors.initials: M
authors.lastname: Zwahlen
authors.forename: Henry
authors.initials: H
authors.lastname: Hoffmann
authors.forename: Christoph
authors.initials: C
authors.lastname: Kindler
authors.forename: Christoph
authors.initials: C
authors.lastname: Fux
authors.forename: Heidi
authors.initials: H
authors.lastname: Misteli
authors.forename: Lukas
authors.initials: L
authors.lastname: Iselin
authors.forename: Andrea Kopp
authors.initials: AK
authors.lastname: Lugli
authors.forename: Christian A
authors.initials: CA
authors.lastname: Nebiker
authors.forename: Urs
authors.initials: U
authors.lastname: von Holzen
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Vinzens
authors.forename: Marco
authors.initials: M
authors.lastname: von Strauss
authors.forename: Stefan
authors.initials: S
authors.lastname: Reck
authors.forename: Marko
authors.initials: M
authors.lastname: Kraljević
authors.forename: Andreas F
authors.initials: AF
authors.lastname: Widmer
authors.forename: Daniel
authors.initials: D
authors.lastname: Oertli
authors.forename: Rachel
authors.initials: R
authors.lastname: Rosenthal
authors.affiliation: Department of General Surgery, University Hospital of Basel, Spitalstrasse 21, 4031 Basel, Switzerland. walter.weber@usb.ch.
authors.forename: Walter P
authors.initials: WP
authors.lastname: Weber
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D006801:Humans; D012107:Research Design; D012307:Risk Factors; D013514:Surgical Procedures, Operative / Q000009:adverse effects*; D013530:Surgical Wound Infection / Q000382:microbiology / Q000517:prevention & control*; D013557:Switzerland; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents