Back to resultsIntra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
Primary Purpose
Infection
Status
Recruiting
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring Vancomycin, Infections, Surgical Site
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
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of care
Intervention group: 500 mg vancomycin
Intervention group: 1 g vancomycin
Arm 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).
Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
Outcomes
Primary Outcome Measures
Incidence of deep spinal infections
According to Center for Disease Control and Prevention (CDC) criteria
Secondary Outcome Measures
Incidence of superficial spinal infections
According to CDC criteria
Individual components of the composite primary outcomes
Deep surgical site infections and superficial surgical site infections separately
Rate of Surgical site infection revisions
Number of surgical site infection revisions
Number of adverse events
Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Length of hospitalization
Length of hospitalization starting on operation date up to discharge or death
Rate of mortality
Rate of mortality among study participants within one year from operation date
Rate of post-operative seroma
Rate of post-operative seroma
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
Creatinine, glucose and albumin lab results
Serum vancomycin levels
Serum vancomycin levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05959603
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Vancomycin, Infections, Surgical Site
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm 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).
Arm Title
Intervention group: 500 mg vancomycin
Arm Type
Experimental
Arm Description
Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
Arm Title
Intervention group: 1 g vancomycin
Arm Type
Experimental
Arm Description
Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of deep spinal infections
Description
According to Center for Disease Control and Prevention (CDC) criteria
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incidence of superficial spinal infections
Description
According to CDC criteria
Time Frame
One year
Title
Individual components of the composite primary outcomes
Description
Deep surgical site infections and superficial surgical site infections separately
Time Frame
One year
Title
Rate of Surgical site infection revisions
Description
Number of surgical site infection revisions
Time Frame
30 days
Title
Number of adverse events
Description
Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Time Frame
Up to one week post-surgery
Title
Length of hospitalization
Description
Length of hospitalization starting on operation date up to discharge or death
Time Frame
From operation date to discharge (up to 4 weeks) or date of death
Title
Rate of mortality
Description
Rate of mortality among study participants within one year from operation date
Time Frame
One year
Title
Rate of post-operative seroma
Description
Rate of post-operative seroma
Time Frame
30 days
Title
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
Description
Creatinine, glucose and albumin lab results
Time Frame
Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30
Title
Serum vancomycin levels
Description
Serum vancomycin levels
Time Frame
6 and 12 hours post op and then one test a day until vancomycin levels reach zero
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eyal Itshayek, MD
Phone
+972-50-8946921
Email
eyal.itshayek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shani Berkowitz, Msc
Phone
+972528620737
Email
shanihberkowitz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Itshayek, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belaynesh Keren Melke, BSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
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