Using vancomycin powder to prevent infections in spine surgery
The Effect of Intrawound Vancomycin Powder in Spine Surgery: A Prospective Randomized Controlled Trial
This study is testing if using vancomycin powder during spine surgery can help prevent infections after the operation compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1643 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Windsor-Essex Compassionate Care Community Academic / other |
| Locations | 2 sites (Windsor, Ontario and 1 other locations) |
| Trial ID | NCT04825522 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intrawound vancomycin powder in reducing postoperative wound infections in patients undergoing spine surgery. Participants will be randomly assigned to receive either the vancomycin intervention or standard care without it, while both the patients and the surgeons will remain blinded to the treatment allocation. Data on patient demographics, comorbidities, and surgical details will be collected, and the incidence of infections will be monitored for 12 weeks post-surgery. The goal is to determine if local vancomycin application can significantly lower the rates of surgical site infections compared to standard practices.
Who should consider this trial
Good fit: Ideal candidates are adults requiring surgery for any spine disease.
Not a fit: Patients with a history of infections at the surgical site or those allergic to vancomycin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative infections, leading to improved patient outcomes and lower healthcare costs.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of intrawound vancomycin, making this investigation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring surgery due to any spine disease. Exclusion Criteria: * A previous history of infections at the spine surgical site. * Biopsy procedure. * Patients with a postoperative follow-up time of less than 12 weeks. * Patients allergic to vancomycin. * Patient is less than 18 years old.
Where this trial is running
Windsor, Ontario and 1 other locations
- Windsor Regional Hospital - Ouellette — Windsor, Ontario, Canada (Recruiting)
- Cairo University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed Soliman, MD — Western University
- Study coordinator: Mohamed Soliman, MSc, MD
- Email: msolim8@uwo.ca
- Phone: 17329241637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.