NCT03883022

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2018Dec 2027

Study Start

First participant enrolled

September 3, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

9 years

First QC Date

March 10, 2019

Last Update Submit

March 18, 2019

Conditions

Spinal FusionSpinal StenosisSpondylolisthesis

Keywords

Deep surgical site infectionVancomycin-impregnated bone graftSpine surgeryDegenerative lumbar disorder

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (2)

  • Vancomycin concentration

    Post-operative days 1

  • Vancomycin concentration

    Post-operative days 3

Study Arms (2)

Vancomycin (V Group)

EXPERIMENTAL
Drug: with U-VANCO (vancomycin hydrochloride)

Without Vancomycin (NV Group)

ACTIVE COMPARATOR
Drug: without U-VANCO (vancomycin hydrochloride)

Interventions

with U-VANCO (vancomycin hydrochloride)DRUG

1 gm or 2 gm mixed with autogenous cancellous bone graft

Vancomycin (V Group)
without U-VANCO (vancomycin hydrochloride)DRUG

no vancomycin added

Without Vancomycin (NV Group)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who agree to accept the spine surgery but do not agree to sign the inform consent
  • Patients who have allergic reaction to vancomycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (1)

  • 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: 40334989DERIVED

MeSH Terms

Conditions

Spinal StenosisSpondylolisthesis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Shih-Tien Wang, MD

    Taipei Veterans General Hospital, Taiwan

    STUDY CHAIR

Central Study Contacts

Shih-Tien Wang, MD

CONTACT

886-2-28757557stwang@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 20, 2019

Study Start

September 3, 2018

Primary Completion (Estimated)

September 12, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

TW(1)