Infection
Conditions
Keywords
Vancomycin, Infections, Surgical Site
Brief summary
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.
Interventions
DRUGVancomycin
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.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center * Ability to understand and sign written informed consent by the patient or legal guardian
Exclusion criteria
* Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment) * Receiving ongoing treatment of antibiotics for other infections * Sensitivity or allergy to vancomycin or cefazolin * Previous spine surgery at the index level within the last 90 days * Postoperative radiotherapy of the surgical site required (e.g. for tumor) * Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse * Undergoing spinal decompression only * Trauma patients * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of deep spinal infections | One year | According to Center for Disease Control and Prevention (CDC) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the composite primary outcomes | One year | Deep surgical site infections and superficial surgical site infections separately |
| Rate of Surgical site infection revisions | 30 days | Number of surgical site infection revisions |
| Number of adverse events | Up to one week post-surgery | Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity |
| Length of hospitalization | From operation date to discharge (up to 4 weeks) or date of death | Length of hospitalization starting on operation date up to discharge or death |
| Incidence of superficial spinal infections | One year | According to CDC criteria |
| Rate of post-operative seroma | 30 days | Rate of post-operative seroma |
| Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl) | Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30 | Creatinine, glucose and albumin lab results |
| Serum vancomycin levels | 6 and 12 hours post op and then one test a day until vancomycin levels reach zero | Serum vancomycin levels |
| Rate of mortality | One year | Rate of mortality among study participants within one year from operation date |
Countries
Israel
Contacts
Primary ContactEyal Itshayek, MD
Backup ContactShani Berkowitz, Msc
Outcome results
None listed