Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: with U-VANCO (vancomycin hydrochloride), without U-VANCO (vancomycin hydrochloride).
- Who it may be relevant to
- Registry conditions: Spinal Fusion, Spinal Stenosis, Spondylolisthesis. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug with U-VANCO (vancomycin hydrochloride)
1 gm or 2 gm mixed with autogenous cancellous bone graft - Drug without U-VANCO (vancomycin hydrochloride)
no vancomycin added
Primary outcome measures
- Bony fusion status [Time frame: Post-operative 1 month]
- Bony fusion status [Time frame: Post-operative 3 months]
- Bony fusion status [Time frame: Post-operative 6 months]
- Bony fusion status [Time frame: Post-operative 1 year]
- Functional outcomes [Time frame: Post-operative 1 month]
- Functional outcomes [Time frame: Post-operative 3 months]
- Functional outcomes [Time frame: Post-operative 6 months]
- Functional outcomes [Time frame: Post-operative 1 year]
- Functional outcomes [Time frame: Post-operative 1 months]
- Functional outcomes [Time frame: Post-operative 3 months]
Secondary outcome measures (2)
- Vancomycin concentration [Time frame: Post-operative days 1]
- Vancomycin concentration [Time frame: Post-operative days 3]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Publications
- Wang ST, Lin HH, Yao YC, Huang N, Hsiung W, Chang MC, Liu CL, Chou PH. Vancomycin powder mixed with autogenous bone graft and bone substitute may decrease the deep surgical site infections in elective lumbar instrumented fusion surgery for degenerative disorders: a prospective randomized study. Spine J. 2025 Sep;25(9):1866-1876. doi: 10.1016/j.spinee.2025.05.001. Epub 2025 May 5. PMID 40334989
Identifiers
NCT: NCT03883022 · 2017-10-008A