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

Clalit Health Services

Status and phase

Enrolling

Phase 3

Conditions

Infection

Treatments

Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT05959603

RMC 0103-20

Details and patient eligibility

About

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.

Enrollment

363 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

363 participants in 3 patient groups

Standard of care

No Intervention group

Description:

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 group

Description:

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

Treatment:

Drug: Vancomycin

Intervention group: 1 g vancomycin

Experimental group

Description:

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

Treatment:

Drug: Vancomycin