Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

Launched by THE UNIVERSITY OF HONG KONG · Feb 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether using a special powder called vancomycin, applied directly to the surgical site during spinal surgery, can help prevent infections that can occur after the procedure. The surgery is often done on patients with spinal deformities, trauma, or tumors, and these patients are at a higher risk for infections. In the trial, some patients will receive the vancomycin powder applied to their wounds, while others will not, allowing researchers to compare the two groups and see if the vancomycin makes a difference in reducing infections.

To be eligible for this trial, participants need to be adults aged 18 or older who are scheduled for specific types of open spinal surgery. They should not have been treated with antibiotics for a spinal infection in the past year, and they should not be pregnant or have known allergies to vancomycin or related medications. Those who join the study can expect to undergo their usual surgery, receive standard post-operative care, and be monitored for any signs of infection as well as how well their kidneys are functioning. This trial aims to provide important information that could help doctors make better decisions in preventing infections after spine surgery.

Gender

ALL

Eligibility 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