Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin.
- Who it may be relevant to
- Registry conditions: Infection. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
Overview
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
- Drug Vancomycin
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.
Primary outcome measures
- Incidence of deep spinal infections [Time frame: One year]
Secondary outcome measures (9)
- Incidence of superficial spinal infections [Time frame: One year]
- Individual components of the composite primary outcomes [Time frame: One year]
- Rate of Surgical site infection revisions [Time frame: 30 days]
- Number of adverse events [Time frame: Up to one week post-surgery]
- Length of hospitalization [Time frame: From operation date to discharge (up to 4 weeks) or date of death]
- Rate of mortality [Time frame: One year]
- Rate of post-operative seroma [Time frame: 30 days]
- Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl) [Time frame: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30]
- Serum vancomycin levels [Time frame: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Rabin Medical Center — Petah Tikva
Identifiers
NCT: NCT05959603 · RMC 0103-20