Combination Surgical Prophylaxis with Vancomycin versus Standard Prophylaxis for the Prevention of Surgical Site Infections following Elective and Expedited Surgery
Multicentre Randomised Double-Blind Placebo Controlled Trial of Combination Vancomycin versus Standard Surgical Antibiotic Prophylaxis
Monash University
4,230 participants
Jan 15, 2019
Interventional
Conditions
Summary
This randomised, double-blind, placebo-controlled, phase 4 trial will compare the incidence of surgical site infection, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to cefazolin plus placebo. The study will be initially undertaken in patients undergoing elective or expedited joint replacement surgery. Dependent on timelines and funding, the study may be expanded to include patients undergoing cardiac surgery.
Eligibility
Inclusion Criteria1
- Patients undergoing elective or expedited surgery
Exclusion Criteria8
- Hypersensitivity to either cefazolin or glycopeptides (vancomycin and teicoplanin)
- Pregnancy and lactating women
- Surgery for suspected or proven surgical site infection
- Emergency or time critical surgery
- Arthroplasty for management of trauma / fracture including fractured neck of femur
- Arthroplasty for bone/soft tissue tumour
- Return to theatre / redo operation within index admission
- Documented or suspected infection or colonisation with MRSA
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Interventions
Single dose intravenous vancomycin (1.5g) administered immediately prior to commencement of surgery. The vancomycin will be administered by the anaesthetist. In addition to vancomycin, all participants will receive standard surgical antimicrobial prophylaxis with intravenous cefazolin (2g). The dose, timing and frequency of cefazolin is in keeping with national guidelines (Therapeutic Guidelines: Antibiotics) as part of standard care.
Locations(14)
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ACTRN12618000642280