InfectionPhase 3NCT05959603
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
A Phase 3 study testing Vancomycin in people with Infection, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infection
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteIsrael
- Study dates
- 31 May 2020to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Undergoing spinal decompression only
- Trauma patients
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Belaynesh Keren Melke, BSc
About this study
Official title: Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
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
- Being tested
- Vancomycin
- Keywords
- Vancomycin, Infections, Surgical Site
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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 | Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis Receives: Drug: Vancomycin |
| Intervention group: 1 g vancomycin | Experimental | Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of deep spinal infections
According to Center for Disease Control and Prevention (CDC) criteria
Measured: One year
Secondary outcomes (9)
Incidence of superficial spinal infections
According to CDC criteria
Measured: One year
Individual components of the composite primary outcomes
Deep surgical site infections and superficial surgical site infections separately
Measured: One year
Rate of Surgical site infection revisions
Number of surgical site infection revisions
Measured: 30 days
Number of adverse events
Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Measured: Up to one week post-surgery
Length of hospitalization
Length of hospitalization starting on operation date up to discharge or death
Measured: From operation date to discharge (up to 4 weeks) or date of death
Rate of mortality
Rate of mortality among study participants within one year from operation date
Measured: One year
Rate of post-operative seroma
Rate of post-operative seroma
Measured: 30 days
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
Creatinine, glucose and albumin lab results
Measured: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30
Serum vancomycin levels
Serum vancomycin levels
Measured: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start31 May 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 363 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Itshayek, Rabin Medical Center
- Investigators
- Eyal Itshayek, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959603
- Sponsor's protocol ID
- RMC 0103-20
- Status last verified
- Jul 2024
- First submitted
- 20 May 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT05959603
- Acronym / sponsor ID
- RMC 0103-20
- Conditions
- Infection
- Keywords
- Vancomycin, Infections, Surgical Site
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 363 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –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 | Drug: VancomycinPatients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis |
| Intervention group: 1 g vancomycin | Experimental | Drug: VancomycinPatients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinPowdered 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. | Drug | Intervention group: 1 g vancomycin, Intervention group: 500 mg vancomycin |
Primary outcome
Incidence of deep spinal infections
Time frame: One year
According to Center for Disease Control and Prevention (CDC) criteria
9 secondary outcomes
Incidence of superficial spinal infections
Time frame: One year
Individual components of the composite primary outcomes
Time frame: One year
Rate of Surgical site infection revisions
Time frame: 30 days
Number of adverse events
Time frame: Up to one week post-surgery
Length of hospitalization
Time frame: From operation date to discharge (up to 4 weeks) or date of death
Rate of mortality
Time frame: One year
Rate of post-operative seroma
Time frame: 30 days
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)
Time frame: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30
Serum vancomycin levels
Time frame: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eyal Itshayek, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin in people with Infection, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eyal Itshayek, MD (+972-50-8946921, eyal.itshayek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of deep spinal infections (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.