← Back to Search

Antibiotic

Vancomycin Powder for Spinal Disorders

Phase 4

Recruiting

Led By Mohamed Soliman, MD

Research Sponsored by Windsor-Essex Compassionate Care Community

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients requiring surgery due to any spine disease

Be older than 18 years old

Must not have

A previous history of infections at the spine surgical site

Patient is less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will help researchers determine whether intra-wound vancomycin powder is effective in reducing post-surgical infection rates in spine surgery patients.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While not explicitly listed, potential side effects may include allergic reactions, irritation at the wound site, and possibly antibiotic resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for a spine condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had infections where I had spine surgery before.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Infection

Secondary study objectives

Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: VancomycinActive Control1 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: ControlActive Control1 Intervention

Participants will not be receiving vancomycin.

0 / 3Eligibility criteria met