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

NCT ID: NCT05959603

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2026-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eyal Itshayek

Prof. Eyal Itshayek

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyal Itshayek, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eyal Itshayek, MD

Role: CONTACT

eyal.itshayek@gmail.com

+972-50-8946921

Shani Berkowitz, Msc

Role: CONTACT

shanihberkowitz@gmail.com

+972528620737

Facility Contacts

Belaynesh Keren Melke, BSc

Role: primary

Other Identifiers

RMC 0103-20

Identifier Type: -

Identifier Source: org_study_id