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

Sponsor

Rabin Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05959603

Collaborator

(none)

363

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Vancomycin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

363 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 31, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Incidence of deep spinal infections [One year]
According to Center for Disease Control and Prevention (CDC) criteria

Secondary Outcome Measures

Incidence of superficial spinal infections [One year]
According to CDC criteria
Individual components of the composite primary outcomes [One year]
Deep surgical site infections and superficial surgical site infections separately
Rate of Surgical site infection revisions [30 days]
Number of surgical site infection revisions
Number of adverse events [Up to one week post-surgery]
Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Length of hospitalization [From operation date to discharge (up to 4 weeks) or date of death]
Length of hospitalization starting on operation date up to discharge or death
Rate of mortality [One year]
Rate of mortality among study participants within one year from operation date
Rate of post-operative seroma [30 days]
Rate of post-operative seroma
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl) [Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30]
Creatinine, glucose and albumin lab results
Serum vancomycin levels [6 and 12 hours post op and then one test a day until vancomycin levels reach zero]
Serum vancomycin levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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