Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | 2 g of IV cefazolin will be administered within 60 minutes before surgical incision (3 g for pts weighing ≥120 kg), repeated dose in the operating room every four hours (allergic patients will receive 900 mg of clindamycin within 60 minutes which will be repeated every six hours or 15 mg/kg of vancomycin once within two hours before incision). | |
| Intervention group: 500 mg vancomycin | Experimental | Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis |
|
| Intervention group: 1 g vancomycin | Experimental | Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of deep spinal infections | According to Center for Disease Control and Prevention (CDC) criteria | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of superficial spinal infections | According to CDC criteria | One year |
| Individual components of the composite primary outcomes | Deep surgical site infections and superficial surgical site infections separately |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eyal Itshayek, MD | Contact | +972-50-8946921 | eyal.itshayek@gmail.com | |
| Shani Berkowitz, Msc | Contact | +972528620737 | shanihberkowitz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eyal Itshayek, MD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| One year |
| Rate of Surgical site infection revisions | Number of surgical site infection revisions | 30 days |
| Number of adverse events | Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity | Up to one week post-surgery |
| Length of hospitalization | Length of hospitalization starting on operation date up to discharge or death | 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 | One year |
| Rate of post-operative seroma | Rate of post-operative seroma | 30 days |
| Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl) | Creatinine, glucose and albumin lab results | Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30 |
| Serum vancomycin levels | Serum vancomycin levels | 6 and 12 hours post op and then one test a day until vancomycin levels reach zero |
| D000602 |
| Amino Acids, Peptides, and Proteins |