Vancomycin Powder for Spinal Disorders

Recruiting at 1 trial location

Overseen By Abdalla Shamisa, FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Windsor-Essex Compassionate Care Community

Disqualifiers: Previous infections, Biopsy, Allergic to vancomycin, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Surgery duration varies

1643 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of vancomycin powder in preventing infections after spinal surgery. Infections pose a significant problem by prolonging and increasing the cost of recovery. Participants will receive either vancomycin powder (an antibiotic) applied to their surgical site or no additional treatment, to determine the powder's efficacy. Individuals requiring spine surgery without a history of infections at the surgical site may be suitable candidates. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for vancomycin powder in spinal surgeries?

Research has shown that using vancomycin powder during spine surgery is generally safe for patients. Studies have found that applying the powder to the wound can help prevent infections after surgery without causing harm. Many clinical studies support its safety, with no major side effects reported. However, some research suggests that its effectiveness in reducing infections can vary. Overall, current evidence supports vancomycin powder as a well-tolerated option for preventing infections in spine surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for spinal disorders, which often focus on systemic antibiotics to prevent infection, vancomycin powder is applied directly during surgery. This local application is key because it delivers a high concentration of the antibiotic right where it's needed, potentially reducing the risk of infection more effectively and minimizing systemic side effects. Researchers are excited about this approach because it could lead to safer surgeries with better outcomes for patients, especially in complex spinal procedures.

What evidence suggests that vancomycin powder might be an effective treatment for reducing post-surgical infection in spinal surgeries?

Research has shown that using vancomycin powder during spinal surgeries can lower the risk of infections at the surgical site. In this trial, some participants will receive vancomycin powder during their surgeries. One study found that applying this powder reduced infection rates in patients undergoing thoracic and lumbar spine surgeries. Another report found it effective in preventing infections during specific spine surgeries, such as PLIF (posterior lumbar interbody fusion). These findings suggest that vancomycin powder plays a crucial role in preventing infections after surgery, making it a valuable tool for improving patient health. ^{4 6 7 8 9}

Who Is on the Research Team?

Mohamed Soliman, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for patients needing surgery for any spinal disease. It aims to see if applying vancomycin powder into the surgical wound can prevent infections after spine surgery.

Inclusion Criteria

I need surgery for a spine condition.

Exclusion Criteria

I have had infections where I had spine surgery before.

I have had a biopsy.

Patients with a postoperative follow-up time of less than 12 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo spinal surgery with or without intrawound vancomycin powder application

Surgery duration varies

1 visit (in-person)

Follow-up

Participants are monitored for wound infections and complications for 12 weeks post-surgery

12 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Vancomycin

Trial Overview The study is testing whether intrawound vancomycin powder reduces post-surgical infections in spine surgeries. Patients are randomly assigned to receive either the vancomycin treatment or no treatment (control group).

How Is the Trial Designed?

Group I: Vancomycin Active Control 1 Intervention

For surgeries involving one level, 500mg of vancomycin will be applied. For surgeries involving greater than 1 level and less than 3 levels, 1gm will be applied and for surgeries greater than 3 levels, 2gms will be applied.

Group II: Control Active Control 1 Intervention

Participants will not be receiving vancomycin.

Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Vancocin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus
• Staphylococcal endocarditis

Approved in European Union as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)

Approved in Canada as Vancomycin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus

Approved in Japan as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis

Who Is Running the Clinical Trial?

Windsor-Essex Compassionate Care Community

Lead Sponsor

Trials

4

Recruited

4,100+

Cairo University

Collaborator

Trials

3,977

Recruited

1,601,000+

Published Research Related to This Trial

A retrospective study of 36 patients undergoing 191 procedures for early-onset scoliosis found that using vancomycin powder significantly reduced the rate of surgical site infections (SSIs) from 13.8% in the control group to 4.8% in the vancomycin group (p = 0.038).

The study suggests that vancomycin powder is effective in preventing SSIs in growing spine surgery, with an estimated 10.9 procedures needed to prevent one infection, indicating its potential as a safe and beneficial intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Vancomycin Powder Decrease Surgical Site Infections in Growing Spine Surgery?: A Preliminary Study. Thompson, GH., Poe-Kochert, C., Hardesty, CK., et al.[2022]

In a study of 289 patients undergoing posterior cervical fusion surgeries, the use of local vancomycin powder did not significantly reduce the rate of deep wound infections compared to those who did not receive the treatment (5.2% vs. 6.9%).

Logistic regression analysis confirmed that the application of vancomycin powder had no meaningful impact on the development of surgical site infections, suggesting that its routine use may not be effective in preventing infections in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with intrawound vancomycin powder for posterior cervical fusion surgery. Martin, JR., Adogwa, O., Brown, CR., et al.[2022]

The local application of vancomycin powder significantly reduces the incidence of surgical site infections (SSI) after spinal surgeries, with a risk ratio of 0.39 based on a meta-analysis of 31 studies.

This method is shown to be both effective and safe, providing strong evidence for its use in clinical practice to prevent infections following spinal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the local application of vancomycin powder to prevent surgical site infection after spinal surgeries. Shan, S., Tu, L., Gu, W., et al.[2021]

The application of local vancomycin powder during spinal surgeries significantly reduces the incidence of surgical site infections (SSI), as shown in a meta-analysis of 50 studies involving 34,301 cases.

This protective effect is particularly strong in surgeries involving internal fixation and deformity correction, while no significant difference was observed in noninstrumented surgeries or superficial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Application of Vancomycin Powder in Preventing Surgical Site Infections After Spinal Surgery. Shu, L., Muheremu, A., Shoukeer, K., et al.[2023]

Applying vancomycin powder directly into the surgical wound during spinal surgery significantly reduces the risk of surgical site infections, with a relative risk of 0.11 based on a meta-analysis of six studies involving 3,379 patients.

There were no recorded adverse events related to vancomycin in the 1,437 patients treated, indicating that its use is safe and does not increase the risk of complications like pseudo-arthrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of vancomycin powder into the wound during spine surgery: systematic review and meta-analysis]. Alcalá-Cerra, G., Paternina-Caicedo, AJ., Moscote-Salazar, LR., et al.[2018]

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]

In a mouse model of spine implant infection, intrawound vancomycin powder significantly reduced bacterial loads and persistent infections compared to controls, indicating its efficacy in preventing infections during spine surgery.

The study found that while vancomycin powder is effective, it does not completely eradicate infections, and lower doses (like 2 mg) still provide protective benefits, suggesting potential for dose adjustments in certain patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress not panacea: vancomycin powder efficacy and dose evaluated in an in vivo mouse model of spine implant infection. Park, HY., Hegde, V., Zoller, SD., et al.[2021]

The study of 209 patients undergoing posterior spinal instrumentation found that local application of vancomycin powder significantly reduced surgical site infection rates from 6.54% in the control group to 1.96% in the treatment group, highlighting its efficacy as a prophylactic measure.

In high-risk populations, such as Syrian refugees, the infection rates were also lower with vancomycin (3.22%) compared to the control group (8.11%), suggesting that vancomycin powder may be particularly beneficial in settings with higher baseline infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of prophylactic application of vancomycin powder in preventing surgical site infections after instrumented spinal surgery: A retrospective analysis of patients with high-risk conditions. Oktay, K., Özsoy, KM., Çetinalp, NE., et al.[2021]

Citations

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

Safety and efficacy of intrawound vancomycin powder in ... Intrawound application of vancomycin powder is a safe and effective procedure for reducing the risk of SSI during PLIF surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7734260/

The Cost-Effectiveness of Vancomycin Powder in Lumbar ... With regard to spine surgery, Sweet et al demonstrated that vancomycin powder reduced the deep infection rate after thoracic and lumbar instrumented spinal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S152994302500539X

P158. Effectiveness of intrawound vancomycin powder in ... ... spine surgery. OUTCOME MEASURES. The primary outcome measure was the incidence of surgical site infections (SSIs) between vancomycin-treated and control groups.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04825522

The Effect of Intrawound Vancomycin Powder in Spine ... According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative ...

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/43/4/article-p509.xml

Intraoperative vancomycin for preventing infection after open ... The use of prophylactic intrasite vancomycin powder in spine surgery has been described as a possible method for infection prevention.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745637/

Safety and efficacy of intrawound vancomycin powder in ... Intrawound application of vancomycin powder is a safe and effective procedure for reducing the risk of SSI during PLIF surgery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462360/

Intrawound vancomycin powder for prevention of surgical site ... In this randomized controlled trial, we aim to investigate the safety and efficacy of intrawound vancomycin powder in reducing the rate of SSIs ...

8. journalofhospitalinfection.com journalofhospitalinfection.com/article/S0195-6701(24)00193-2/fulltext

Effect of topical vancomycin powder on surgical site ... This systematic review and meta-analysis suggests inconclusive results regarding the effect of VCM powder in reducing SSI in major orthopaedic surgeries.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875014014041

The Use of Vancomycin Powder In Modern Spine Surgery Numerous clinical studies have confirmed the safety of using vancomycin powder in the surgical site. The pooled clinical data supports the use of vancomycin to ...