Using vancomycin powder with bone graft to prevent infections after spine surgery
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
This study is testing if using vancomycin powder with bone grafts can help prevent infections after spine surgery for patients who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT03883022 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of vancomycin powder combined with autogenous bone graft in preventing deep surgical site infections (DSSI) in patients undergoing spinal fusion surgeries. It aims to assess whether this combination can reduce the incidence of DSSI without negatively impacting bone fusion. The study includes patients who have not responded to conservative treatments and are undergoing instrumented spine fusion surgery. Participants will be monitored for infection rates and fusion outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing instrumented spine fusion surgery due to failed conservative treatment for degenerative lumbar disorders.
Not a fit: Patients who are allergic to vancomycin or unwilling to sign the informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections following spinal surgeries, leading to better recovery outcomes for patients.
How similar studies have performed: While the use of antibiotics in surgical procedures is common, the specific combination of vancomycin with autogenous bone graft in spine surgery is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months * Patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks * Patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent * Patients who agree one more blood withdrawal after operation Exclusion Criteria: * Patients who agree to accept the spine surgery but do not agree to sign the inform consent * Patients who have allergic reaction to vancomycin
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shih-Tien Wang, MD
- Email: stwang@vghtpe.gov.tw
- Phone: 886-2-28757557
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.