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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03883022

Enrollment

400

Registered

2019-03-20

Start date

2018-09-03

Completion date

2027-12-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion, Spinal Stenosis, Spondylolisthesis

Keywords

Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder

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.

Interventions

DRUGwith U-VANCO (vancomycin hydrochloride)

1 gm or 2 gm mixed with autogenous cancellous bone graft

DRUGwithout U-VANCO (vancomycin hydrochloride)

no vancomycin added

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bony fusion status	Post-operative 1 month	The bony fusion status (Lenke criteria)
Functional outcomes	Post-operative 1 month	Functional outcomes, visual analogue scale (VAS)

Secondary

Measure	Time frame	Description
Vancomycin concentration	Post-operative days 1	Vancomycin concentration was checked for both the serum and drainage.

Countries

Taiwan

Contacts

Primary ContactShih-Tien Wang, MD

stwang@vghtpe.gov.tw886-2-28757557

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026