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Recruiting NCT03883022

Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery

◆ AI Clinical Summary

This study examines whether mixing vancomycin powder (an antibiotic) with bone graft material used during spine surgery can prevent serious infections after the operation. Researchers are comparing patients who receive this antibiotic-enhanced bone graft with those who receive standard bone graft without the antibiotic.

Key Objective: The trial is testing whether vancomycin powder mixed with bone graft reduces the risk of deep surgical site infections following spinal fusion surgery.

Who to Consider: Patients undergoing spinal fusion surgery who are concerned about post-operative infection risk should consider enrolling in this study.

Trial Parameters

Condition Spinal Fusion
Sponsor Taipei Veterans General Hospital, Taiwan
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 20 Years
Max Age N/A
Start Date 2018-09-03
Completion 2027-09-12
Interventions
with U-VANCO (vancomycin hydrochloride)without U-VANCO (vancomycin hydrochloride)

Brief Summary

Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.

Eligibility 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

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