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Clinical Trials in Taiwan / NCT03883022
Recruiting Not applicable

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

NCT03883022 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Taipei Veterans General Hospital, Taiwan
Phase
Not applicable
Started
2018-09-03
Last updated
2019-03-20

Condition(s) studied

Spinal FusionSpinal StenosisSpondylolisthesis

Investigational drug(s) / intervention(s)

with U-VANCO (vancomycin hydrochloride)without U-VANCO (vancomycin hydrochloride)

with U-VANCO (vancomycin hydrochloride): 1 gm or 2 gm mixed with autogenous cancellous bone graft

without U-VANCO (vancomycin hydrochloride): no vancomycin added

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bony fusion status — Post-operative 1 month
    The bony fusion status (Lenke criteria)
  • Bony fusion status — Post-operative 3 months
    The bony fusion status (Lenke criteria)
  • Bony fusion status — Post-operative 6 months
    The bony fusion status (Lenke criteria)
  • Bony fusion status — Post-operative 1 year
    The bony fusion status (Lenke criteria)
  • Functional outcomes — Post-operative 1 month
    Functional outcomes, visual analogue scale (VAS)
  • Functional outcomes — Post-operative 3 months
    Functional outcomes, visual analogue scale (VAS)
  • Functional outcomes — Post-operative 6 months
    Functional outcomes, visual analogue scale (VAS)
  • Functional outcomes — Post-operative 1 year
    Functional outcomes,visual analogue scale (VAS)
  • Functional outcomes — Post-operative 1 months
    Functional outcomes,oswestry disability index (ODI)
  • Functional outcomes — Post-operative 3 months
    Functional outcomes, oswestry disability index (ODI)
  • Functional outcomes — Post-operative 6 months
    Functional outcomes, oswestry disability index (ODI)
  • Functional outcomes — Post-operative 1 year
    Functional outcomes, oswestry disability index (ODI)

Trial sites (1)

FacilityCityRegionStatus
Taipei Veterans General Hospital Taipei Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03883022 on ClinicalTrials.gov ↗ ← All trials in Taiwan