Intraosseous Vancomycin for Lumbar Fusion Surgery

Overseen By Emily Vidal

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Previous spine surgery, BMI > 40, Uncontrolled diabetes, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using the antibiotic vancomycin during spinal fusion surgery. Instead of administering vancomycin intravenously, the trial tests direct injection into the bone marrow to assess its effectiveness. Individuals preparing for certain types of spinal fusion surgeries who can consent to participate might be suitable candidates. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications that affect your immune system, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A study of 253 patients who underwent spine surgery found that applying vancomycin powder directly at the surgical site reduced infection rates from 11% to less than 2%. This demonstrates that direct application of vancomycin is safe and effective in preventing infections. Another study discovered that mixing vancomycin with bone grafts maintained high levels of the drug at the surgical site, proving it effective and safe for infection prevention. These findings indicate that using vancomycin directly in surgery is well-tolerated and reduces the risk of infection. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about intraosseous vancomycin for lumbar fusion surgery because it offers a new delivery method directly into the bone. Unlike traditional intravenous antibiotics, which circulate through the bloodstream, this method targets the surgical site more precisely, potentially improving infection control. This direct delivery could enhance effectiveness and reduce systemic exposure, minimizing side effects. By targeting the infection risk at its source, intraosseous vancomycin provides a promising alternative to existing methods like intravenous ancef or cefepime.

What evidence suggests that intraosseous vancomycin might be an effective treatment for lumbar fusion surgery?

Research has shown that applying vancomycin directly in the bone during back surgery can help reduce infections. In this trial, participants will receive either intravenous vancomycin or intraosseous vancomycin. A study with 253 patients found that using vancomycin powder lowered the infection rate from 11% to 4%. Another study discovered that mixing vancomycin with bone grafts (a bone substitute) maintained high levels of the drug at the surgery site, helping to prevent infections. Overall, most studies suggest that this method can lower the risk of infections after spine surgery, making the use of vancomycin in the bone a promising option for safer surgeries. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing lumbar fusion surgery. Specific eligibility criteria are not provided, so participants should consult with the research team to determine if they meet the necessary requirements for inclusion.

Inclusion Criteria

Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study

I am older than 18 years.

I am having spine surgery involving fusion.

Exclusion Criteria

My diabetes is not well-controlled, and my kidney function is low.

I do not wish to participate in the trial.

I cannot take certain antibiotics like vancomycin or cefepime due to allergies or other issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive pre-operative antibiotic regimen including IV antibiotics approximately 1 hour prior to incision

1 day

1 visit (in-person)

Surgery

Participants undergo lumbar fusion surgery with either intraosseous or intravenous vancomycin administration

1 day

1 visit (in-person)

Post-operative Follow-up

Participants' charts are reviewed for post-operative complications and vancomycin concentration levels are assessed

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Vancomycin

Trial Overview The study is examining whether injecting vancomycin directly into bone marrow (intraosseous) during lumbar fusion surgery has equal or greater effectiveness compared to standard intravenous administration.

How Is the Trial Designed?

Group I: Intraosseous Vancomycin Experimental Treatment 1 Intervention

Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium.

Group II: Intravenous Vancomycin Active Control 1 Intervention

Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500mL NS).

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a study of 253 patients undergoing lumbar laminectomy and fusion, the use of 1g vancomycin powder significantly reduced the wound infection rate from 11% to 0%, demonstrating its efficacy in preventing infections after spinal surgery.

The reduction in infection rates was observed in both instrumented (from 12% to 0%) and non-instrumented cases (from 10% to 0%), with no complications linked to the use of vancomycin powder, indicating it is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar laminectomy and fusion with routine local application of vancomycin powder: decreased infection rate in instrumented and non-instrumented cases. Strom, RG., Pacione, D., Kalhorn, SP., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06748144

Study Details | NCT06748144 | IO Vancomycin Spine The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion ...

2. withpower.com withpower.com/trial/intraosseous-vancomycin-for-lumbar-fusion-surgery-3fbca

Intraosseous Vancomycin for Lumbar Fusion Surgery In a study of 253 patients undergoing lumbar laminectomy and fusion, the use of 1g vancomycin powder significantly reduced the wound infection rate from 11% to ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943025002293

Vancomycin powder mixed with autogenous bone graft ... Vancomycin mixed with local ABG and bone substitute maintains high vancomycin level at surgical site and appears safe and effective for preventing DSSI.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6584447/

Effect of Intra‐wound Vancomycin for Spinal Surgery Most studies support the conclusion that intra‐wound vancomycin powder used in spine surgery can reduced the postoperative incidence of wound infection without ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-2-3-io-vancomycin-spine-trial-nct06748144

IO Vancomycin Spine ... Intraosseous and Intravenous Vancomycin ... This is a clinical trial comparing two methods of administering vancomycin during lumbar (spinal) fusion surgery.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38913429/

Safety and efficacy of intrawound vancomycin powder in ... The follow-up rate was 91%. All participants were followed up for at least 90 days. The 90-day SSI rate in the vancomycin group was 1.3% (1/78), ...

7. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/9/10/EOR-23-0023.xml

Efficacy and safety of vancomycin for local application in the ... The aim of this systematic review and meta-analysis is to explore the effect of topical vancomycin powder (VP) in surgical site infection (SSI) ...