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

Trial Summary

What is the purpose of this trial?

Problem: Postoperative wound infection following various spinal surgeries is a serious complication. The incidence of post-surgical wounds in spine surgery is high, and various researchers have reported different infection rates. In addition, increased healthcare costs, prolonged lengths of stay in hospital, and reduced quality of life as a result of surgical site infections (SSI) are also major concerns. Several methods for avoiding SSI, such as betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder, have been used to reduce the rate of wound infection in spine surgery. Use of local vancomycin has been popular because of its protective effects and lower cost. According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative wound infection rates; however, other studies have revealed a non-significant effect of intra-wound vancomycin use for decreasing the postsurgical wound infection rate. Solution: Therefore, the investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.

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 data supports the effectiveness of the drug Vancomycin Powder for treating spinal disorders?

Research shows that using vancomycin powder during spinal surgeries can reduce the risk of infections at the surgical site, which is a common complication in these procedures. ^{1 2 3 4 5}

Is vancomycin powder safe for use in spinal surgeries?

Research shows that vancomycin powder is generally safe when used during spinal surgeries to prevent infections, including in children. It has been used without significant safety concerns in various spinal procedures. ^{1 3 5 6 7}

How is vancomycin powder used in spinal surgeries different from other treatments?

Vancomycin powder is unique because it is applied directly to the surgical site during spinal surgeries to prevent infections, unlike other treatments that may be given orally or intravenously. This local application helps reduce the risk of surgical site infections, which are common complications in spinal surgeries. ^{1 2 4 5 8}

Research Team

Mohamed Soliman, MD

Principal Investigator

Western University

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the local application of vancomycin powder to prevent surgical site infection after spinal surgeries. [2021]

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

Prophylactic Application of Vancomycin Powder in Preventing Surgical Site Infections After Spinal Surgery. [2023]

3. Turkey 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. [2021]

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

Experience with intrawound vancomycin powder for posterior cervical fusion surgery. [2022]

5. 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]

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

Does Vancomycin Powder Decrease Surgical Site Infections in Growing Spine Surgery?: A Preliminary Study. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Application of vancomycin powder into the wound during spine surgery: systematic review and meta-analysis]. [2018]

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

Progress not panacea: vancomycin powder efficacy and dose evaluated in an in vivo mouse model of spine implant infection. [2021]