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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Fusion, Spinal Stenosis, Spondylolisthesis

Intervention / Treatment
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* Drug: with U-VANCO (vancomycin hydrochloride)
* Drug: without U-VANCO (vancomycin hydrochloride)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin (V Group)<br> | Drug: with U-VANCO (vancomycin hydrochloride)<br>* 1 gm or 2 gm mixed with autogenous cancellous bone graft<br>|
| Active Comparator: Without Vancomycin (NV Group)<br> | Drug: without U-VANCO (vancomycin hydrochloride)<br>* no vancomycin added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bony fusion status | The bony fusion status (Lenke criteria) | Post-operative 1 month | 
| Bony fusion status | The bony fusion status (Lenke criteria) | Post-operative 3 months | 
| Bony fusion status | The bony fusion status (Lenke criteria) | Post-operative 6 months | 
| Bony fusion status | The bony fusion status (Lenke criteria) | Post-operative 1 year | 
| Functional outcomes | Functional outcomes, visual analogue scale (VAS) | Post-operative 1 month | 
| Functional outcomes | Functional outcomes, visual analogue scale (VAS) | Post-operative 3 months | 
| Functional outcomes | Functional outcomes, visual analogue scale (VAS) | Post-operative 6 months | 
| Functional outcomes | Functional outcomes,visual analogue scale (VAS) | Post-operative 1 year | 
| Functional outcomes | Functional outcomes,oswestry disability index (ODI) | Post-operative 1 months | 
| Functional outcomes | Functional outcomes, oswestry disability index (ODI) | Post-operative 3 months | 
| Functional outcomes | Functional outcomes, oswestry disability index (ODI) | Post-operative 6 months | 
| Functional outcomes | Functional outcomes, oswestry disability index (ODI) | Post-operative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancomycin concentration | Vancomycin concentration was checked for both the serum and drainage. | Post-operative days 1 | 
| Vancomycin concentration | Vancomycin concentration was checked for both the serum and drainage. | Post-operative days 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder