Clinical trial NCT05959603: Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
Official title: Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Infection
Keywords: Vancomycin
Infections
Surgical Site
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of deep spinal infections
timeFrame: One year
Secondary outcomes:
measure: Incidence of superficial spinal infections
timeFrame: One year
measure: Individual components of the composite primary outcomes
timeFrame: One year
measure: Rate of Surgical site infection revisions
timeFrame: 30 days
measure: Number of adverse events
timeFrame: Up to one week post-surgery
measure: Length of hospitalization
timeFrame: From operation date to discharge (up to 4 weeks) or date of death
measure: Rate of mortality
timeFrame: One year
measure: Rate of post-operative seroma
timeFrame: 30 days
measure: Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
timeFrame: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30
measure: Serum vancomycin levels
timeFrame: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Eyal Itshayek, MD
role: PRINCIPAL_INVESTIGATOR
References: