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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959603
• Other study ID #: RMC 0103-20
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2023
• Source: Rabin Medical Center
• Contact: Eyal Itshayek, MD
• Phone: +972-50-8946921
• Email: eyal.itshayek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 363
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of deep spinal infections	According to Center for Disease Control and Prevention (CDC) criteria	One year
Secondary	Incidence of superficial spinal infections	According to CDC criteria	One year
Secondary	Individual components of the composite primary outcomes	Deep surgical site infections and superficial surgical site infections separately	One year
Secondary	Rate of Surgical site infection revisions	Number of surgical site infection revisions	30 days
Secondary	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
Secondary	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
Secondary	Rate of mortality	Rate of mortality among study participants within one year from operation date	One year
Secondary	Rate of post-operative seroma	Rate of post-operative seroma	30 days
Secondary	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
Secondary	Serum vancomycin levels	Serum vancomycin levels	6 and 12 hours post op and then one test a day until vancomycin levels reach zero