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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin (V Group) | Experimental |
| |
| Without Vancomycin (NV Group) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| with U-VANCO (vancomycin hydrochloride) | Drug | 1 gm or 2 gm mixed with autogenous cancellous bone graft |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shih-Tien Wang, MD | Contact | 886-2-28757557 | 9 | stwang@vghtpe.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Shih-Tien Wang, MD | Taipei Veterans General Hospital, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40334989 | Derived | 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. |
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| without U-VANCO (vancomycin hydrochloride) | Drug | no vancomycin added |
|
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 |
| Post-operative days 3 |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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