Using vancomycin powder to prevent infections after spinal surgery
Randomized, Controlled, Single-blinded Trial to Evaluate the Efficacy and Safety of Intra-wound Administration of Vancomycin Powder as Add-on Prophylactic Intraoperative Antibiotic in Patients at High Risk for Surgical Site Infections After Receiving Open Posterior Spinal Surgery
NA · The University of Hong Kong · NCT03839914
This study tests if using vancomycin powder during spinal surgery can help prevent infections in patients who are at high risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03839914 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of using intra-wound vancomycin powder as a preventive measure against surgical site infections in high-risk patients undergoing open posterior spinal surgery. Participants will be randomly assigned to receive either the vancomycin powder or standard care without the antibiotic. The study aims to determine if the addition of vancomycin can significantly reduce infection rates and assess its cost-effectiveness compared to standard practices. The trial is designed as a prospective, single-blinded randomized controlled trial to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing open posterior spinal surgery for spinal deformity, trauma, or tumors.
Not a fit: Patients undergoing minimally invasive surgery or those with a history of vancomycin resistance or allergies to vancomycin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections in high-risk spinal surgery patients.
How similar studies have performed: While the use of topical vancomycin has gained popularity, high-quality evidence specifically for its use in open posterior spinal surgery is limited, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female or male adult with age ≥18 years 2. Undergoing open posterior spinal surgery with instrumentation indicated for spinal deformity, trauma and tumor 3. Able to understand the nature, scope and possible consequences of participation in the study 4. Appropriate voluntary written informed consent have been provided by patients Exclusion Criteria: 1. Has been treated with antibiotics due to primary spinal infection (i.e. spondylodiscitis) within 1 year prior to surgery 2. Ongoing treatment with antibiotics for other infections 3. Undergoing minimally invasive surgery or anterior-only surgical approaches or deformity correction surgery for adolescent idiopathic scoliosis (inherent low-risk for surgical site infections18) 4. Undergoing decompression-only surgery for cervical spine, spinal deformity, trauma and tumors 5. Has known history of allergy to vancomycin, penicillin and other glycopeptides (teicoplanin) 6. Has history of vancomycin resistance 7. Pregnancy
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Jason PY Cheung
- Email: cheungjp@hku.hk
- Phone: (852) 22554581
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.
Conditions: Spinal Deformity, Trauma, Spinal Tumor, Surgical Site Infection, vancomycin powder, surgical site infection, open posterior spinal surgery