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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000642280

Acronym

ASAP

Enrollment

4362

Registered

2018-04-23

Start date

2019-01-15

Completion date

2021-10-31

Last updated

2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients undergoing elective or expedited surgery

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

Outcome results