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

NCT05959603 | Recruiting Phase 3 FDA Drug

• 1 other identifier: RMC 0103-20
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection

Keywords

Vancomycin; Infections; Surgical Site

Outcome Measures

Primary Outcomes (1)

• Incidence of deep spinal infections

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

  One year

Secondary Outcomes (9)

• Incidence of superficial spinal infections

  One year

• Individual components of the composite primary outcomes

  One year

• Rate of Surgical site infection revisions

  30 days

• Number of adverse events

  Up to one week post-surgery

• Length of hospitalization

  From operation date to discharge (up to 4 weeks) or date of death

Study Arms (3)

Standard of care

NO INTERVENTION

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).

Intervention group: 500 mg vancomycin

EXPERIMENTAL

Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis

Drug: Vancomycin

Intervention group: 1 g vancomycin

EXPERIMENTAL

Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis

Drug: Vancomycin

Interventions

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.

Intervention group: 1 g vancomycin; Intervention group: 500 mg vancomycin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Eyal Itshayek, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Itshayek, MD

CONTACT

+972-50-8946921; eyal.itshayek@gmail.com

Shani Berkowitz, Msc

CONTACT

+972528620737; shanihberkowitz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Eyal Itshayek

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: July 25, 2023
• Study Start: May 31, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-07

Locations

IL (1)