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

T

Taipei Veterans General Hospital

Status

Enrolling

Conditions

Spondylolisthesis
Spinal Stenosis
Spinal Fusion

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03883022
2017-10-008A

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups

Vancomycin (V Group)
Experimental group
Treatment:
Drug: with U-VANCO (vancomycin hydrochloride)
Without Vancomycin (NV Group)
Active Comparator group
Treatment:
Drug: without U-VANCO (vancomycin hydrochloride)

Trial contacts and locations

1

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Central trial contact

Shih-Tien Wang, MD

Data sourced from clinicaltrials.gov

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