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Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial
Edin Mujagic, Tibor Zwimpfer, Walter R Marti
1Department of General Surgery, University Hospital of Basel, Spitalstrasse 21, 4031 Basel, Switzerland. walter.weber@usb.ch.
Trials
|June 3, 2014
Summary
Administering surgical antimicrobial prophylaxis 75 to 30 minutes before incision may significantly reduce surgical site infections. This randomized controlled trial investigates optimal timing for enhanced patient safety and healthcare economics.
Area of Science:
- Infectious Diseases
- Surgical Infections
- Clinical Trials
Background:
- Surgical site infections (SSIs) are common hospital-acquired infections.
- Optimal timing for surgical antimicrobial prophylaxis (SAP) is debated.
- Observational studies suggest SAP 74-30 minutes pre-surgery may be beneficial.
Purpose of the Study:
- To investigate the optimal timing for administering surgical antimicrobial prophylaxis.
- To compare SSI rates based on SAP timing: anesthesia room vs. operating room.
- To inform international guidelines on infection control strategies.
Main Methods:
- Bi-center randomized controlled trial (RCT) with 5,000 patients.
- Randomization: 1:1 ratio for SAP in anesthesia room (75-30 min pre-incision) vs. operating room (<30 min pre-incision).
- Primary outcome: SSI occurrence within 30 days (1 year with implant).
Main Results:
- Anticipated significantly lower SSI rates with SAP administered >30 minutes before incision.
- Study powered to detect a 33% relative risk reduction in SSIs.
- Expected study completion within three years.
Conclusions:
- Results will impact international guidelines for infection control.
- Findings are significant for patient safety.
- Study has implications for healthcare economics.
