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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug vancomycin in lumbar fusion surgery?

Research shows that using vancomycin mixed in bone grafts and saline wash during lumbar spine surgery significantly reduces infection rates, with only 1 out of 31 patients experiencing infection compared to 6 out of 32 in the group not using vancomycin. ^{1 2 3 4 5}

Is intraosseous vancomycin safe for use in lumbar fusion surgery?

Intraosseous vancomycin, when used in spinal surgeries, appears to be generally safe with a low rate of side effects. Some rare side effects reported include kidney issues, temporary hearing loss, and fluid buildup at the surgical site, but these occurred in a very small number of patients. ^{2 3 6 7 8}

How is the drug vancomycin used in lumbar fusion surgery different from other treatments?

Vancomycin is unique in lumbar fusion surgery because it is applied directly as a powder to the surgical site to prevent infections, which is different from the usual systemic administration (throughout the body) of antibiotics. This local application helps reduce the risk of surgical site infections more effectively than traditional methods. ^{1 3 4 8 9}

What is the purpose of this trial?

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 surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Vancomycin Use in Posterior Lumbar Interbody Fusion of Deep Surgical Site Infection. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Vancomycin Mixed Bone Graft and Vancomycin Mixed Saline Wash Before Wound Closure Reduces the Rate of Infection in Lumbar Spine Fusion Surgery. [2021]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Local administration of vancomycin powder in posterior lumbar fusion surgery]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The inhibitory effects of vancomycin on rat bone marrow-derived mesenchymal stem cell differentiation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A novel rodent model of chronic spinal implant-associated infection. [2023]

6. Netherlands 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Effect of Intra-wound Vancomycin for Spinal Surgery: A Systematic Review and Meta-analysis. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Intraoperative Intrawound Antibiotic Administration on Spinal Fusion: A Comparison of Vancomycin and Tobramycin in a Rat Model. [2021]