Health TrialsbyHealthPanel

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

ConditionInfection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRabin Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

363 Participants
are divided into 3 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: Intervention group: 500 mg vancomycinExperimental treatment 1 intervention
Group C: Intervention group: 1 g vancomycinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of deep spinal infections

According to Center for Disease Control and Prevention (CDC) criteria

Time frame
One year

Secondary outcomes

1

Incidence of superficial spinal infections

According to CDC criteria

Time frame
One year
2

Individual components of the composite primary outcomes

Deep surgical site infections and superficial surgical site infections separately

Time frame
One year
3

Rate of Surgical site infection revisions

Number of surgical site infection revisions

Time frame
30 days
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rabin Medical Center

Lead sponsor

Source ClinicalTrials.gov
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