Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
363
Powdered vancomycin will be locally administered once during surgery. The vancomycin will be placed in the surgical bed at several layers: around the hardware and before muscle apposition and above the fascia. This is done before the closure of the muscular fascia and skin by the neurosurgeon. The vancomycin will not be mixed in the bone graft.
Rabin Medical Center
Petah Tikva, Israel
RECRUITINGIncidence of deep spinal infections
According to Center for Disease Control and Prevention (CDC) criteria
Time frame: One year
Incidence of superficial spinal infections
According to CDC criteria
Time frame: One year
Individual components of the composite primary outcomes
Deep surgical site infections and superficial surgical site infections separately
Time frame: One year
Rate of Surgical site infection revisions
Number of surgical site infection revisions
Time frame: 30 days
Number of adverse events
Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Time frame: Up to one week post-surgery
Length of hospitalization
Length of hospitalization starting on operation date up to discharge or death
Time frame: From operation date to discharge (up to 4 weeks) or date of death
Rate of mortality
Rate of mortality among study participants within one year from operation date
Time frame: One year
Rate of post-operative seroma
Rate of post-operative seroma
Time frame: 30 days
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
Creatinine, glucose and albumin lab results
Time frame: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30
Serum vancomycin levels
Serum vancomycin levels
Time frame: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero
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