Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial

Conditions
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Infection

Intervention / Treatment
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* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>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). | |
| Experimental: Intervention group: 500 mg vancomycin<br>Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis | Drug: Vancomycin<br>* 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.<br>|
| Experimental: Intervention group: 1 g vancomycin<br>Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis | Drug: Vancomycin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep spinal infections | According to Center for Disease Control and Prevention (CDC) criteria | One year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vancomycin, Infections, Surgical Site