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

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

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Drug: Vancomycin

• Study Type: Interventional
• Enrollment (Estimated): 363
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eyal Itshayek, MD; Phone Number: +972-50-8946921; Email: eyal.itshayek@gmail.com
• Study Contact Backup: Name: Shani Berkowitz, Msc; Phone Number: +972528620737; Email: shanihberkowitz@gmail.com

Study Locations

• Israel
  • Petah tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Belaynesh Keren Melke, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; 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; Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis	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.
Experimental: Intervention group: 1 g vancomycin; Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Eyal Itshayek, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Vancomycin; Infections; Surgical Site
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Bacterial Agents; Anti-Infective Agents; Vancomycin
• Other Study ID Numbers: RMC 0103-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes