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NCT Number: NCT03883022

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

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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Key information

Conditions

Spinal Fusion Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Shih-Tien Wang, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

with U-VANCO (vancomycin hydrochloride)

Drug

1 gm or 2 gm mixed with autogenous cancellous bone graft

without U-VANCO (vancomycin hydrochloride)

Drug

no vancomycin added

Primary outcomes

  1. Bony fusion status

    Time frame: Post-operative 1 month

    The bony fusion status (Lenke criteria)

  2. Bony fusion status

    Time frame: Post-operative 3 months

    The bony fusion status (Lenke criteria)

  3. Bony fusion status

    Time frame: Post-operative 6 months

    The bony fusion status (Lenke criteria)

  4. Bony fusion status

    Time frame: Post-operative 1 year

    The bony fusion status (Lenke criteria)

  5. Functional outcomes

    Time frame: Post-operative 1 month

    Functional outcomes, visual analogue scale (VAS)

  6. Functional outcomes

    Time frame: Post-operative 3 months

    Functional outcomes, visual analogue scale (VAS)

  7. Functional outcomes

    Time frame: Post-operative 6 months

    Functional outcomes, visual analogue scale (VAS)

  8. Functional outcomes

    Time frame: Post-operative 1 year

    Functional outcomes,visual analogue scale (VAS)

  9. Functional outcomes

    Time frame: Post-operative 1 months

    Functional outcomes,oswestry disability index (ODI)

  10. Functional outcomes

    Time frame: Post-operative 3 months

    Functional outcomes, oswestry disability index (ODI)

  11. Functional outcomes

    Time frame: Post-operative 6 months

    Functional outcomes, oswestry disability index (ODI)

  12. Functional outcomes

    Time frame: Post-operative 1 year

    Functional outcomes, oswestry disability index (ODI)

Secondary outcomes

  1. Vancomycin concentration

    Time frame: Post-operative days 1

    Vancomycin concentration was checked for both the serum and drainage.

  2. Vancomycin concentration

    Time frame: Post-operative days 3

    Vancomycin concentration was checked for both the serum and drainage.

Study contacts

Contact information is provided by the study sponsor or research team.

Shih-Tien Wang, MD

CONTACT

[email protected]

886-2-28757557 ext. 9

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2019
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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