Intraosseous Vancomycin for Lumbar Fusion Surgery
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.12345
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.23467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Participants receive pre-operative antibiotic regimen including IV antibiotics approximately 1 hour prior to incision
Surgery
Participants undergo lumbar fusion surgery with either intraosseous or intravenous vancomycin administration
Post-operative Follow-up
Participants' charts are reviewed for post-operative complications and vancomycin concentration levels are assessed
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Published Research Related to This Trial
Citations
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 ...
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 ...
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.
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 ...
IO Vancomycin Spine
... Intraosseous and Intravenous Vancomycin ... This is a clinical trial comparing two methods of administering vancomycin during lumbar (spinal) fusion surgery.
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), ...
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) ...
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