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Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis

Research Project
 | 
01.09.2012
 - 31.08.2015

Surgical Site Infections (SSI) are the most common hospital-acquired infections among surgical patients and are the cause of a substantial disease burden. The administration of surgical antimicrobial prophylaxis (SAP) reduces the risk of SSI in many types of surgical procedures. The optimal timing for this procedure, however, is still a matter of debate. While most studies suggest that SAP should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of SSI. A large observational study conducted in Switzerland suggests that SAP should be administered 74 to 30 minutes before surgery. We propose to conduct a bicenter prospective randomized controlled trial (RCT) at two tertiary referral centers in Switzerland, the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to compare two different delivery modi for SAP, which will result in different average administration times: SAP delivery in the anesthesia room (more than 30 minutes before incision) vs SAP delivery in the operating room (less than 30 minutes before incision). We hypothesize that the rate of SSI is significantly lower with administration of SAP more than 30 minutes before the scheduled incision (in the anesthesia room) as compared with less than 30 minutes before the scheduled incision (in the operating room). We plan to include 5000 patients undergoing visceral, vascular and trauma procedures -2500 per treatment arm- and assess the occurrence of SSI during a 30 day follow-up period (1 year if an implant is in place). When assuming a 5% SSI risk with administration of SAP in the operating room, the planned study size has 80% power to detect a relative risk reduction for SSI of 33% when administering SAP in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within 3 years. The following factors underscore our competence to perform this RCT: First, we have extensive experience in SSI prevention and control. We have conducted several observational and interventional studies on this topic that resulted in publications in high-impact journals. Second, an electronic SSI surveillance system has been introduced as an accurate tool to register in-hospital SSI at the University Hospital of Basel and will be established at the Aarau study site by mid 2011. Third, the routine use of a single-shot, single-drug SAP regime at the two study sites facilitates the conduct of the proposed RCT. The results of the proposed RCT will have an important impact on current international guidelines for infection control strategies in the hospital. In addition, the results of this RCT are of significant interest for patient safety and healthcare economics.

Members (2)

MALE avatar

Walter Weber

Principal Investigator
FEMALE avatar

Rachel Rosenthal

Co-Investigator