Combination Surgical Prophylaxis with Vancomycin versus Standard Prophylaxis for the Prevention of Surgical Site Infections following Elective and Expedited Surgery
Monash UniversityDataset description
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.
Subjects
Health surveillance |Identifiers
Source Study
Trial name (public)
Combination Surgical Prophylaxis with Vancomycin versus Standard Prophylaxis for the Prevention of Surgical Site Infections following Elective and Expedited SurgeryTrial acronym
ASAP
Trial ID
ACTRN12618000642280
Purpose
Prevention
Phase
Phase 4
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Dr Trisha Peel
Brief 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.
Key Inclusion Criteria
Patients undergoing elective or expedited surgery
Key Exclusion Criteria
• 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
Can healthy volunteers participate?
No
Population
Sample Size 4362
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Antimicrobial Resistance , Surgical Antimicrobial Prophylaxis
Condition code Infection , Surgery
Intervention
Intervention code Prevention , Treatment: Drugs
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.
Comparison
Control group Placebo
Placebo will consist of 280mL of 0.9% saline (identical in appearance and volume to the vancomycin solution). The placebo will be administered immediately prior to commencement of surgery and will be administered by the anaesthetist. 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.
Outcomes
Outcome: The primary endpoint for this trial is a composite endpoint comprised of the incidence surgical site infections (superficial incisional, deep and organ/space SSI) defined according to modified CDC definitions. Participants will be followed for 90 days for clinical outcomes The processes for identifying outcomes will be conducted by the project research officer. Active surveillance for the primary outcome will comprise the following: • Review of all participants’ medi .... Read more