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

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ClinicalTrials.gov Identifier: NCT03883022
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Spinal Fusion Spinal Stenosis Spondylolisthesis Drug: with U-VANCO (vancomycin hydrochloride) Drug: without U-VANCO (vancomycin hydrochloride) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 12, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Vancomycin (V Group) Drug: with U-VANCO (vancomycin hydrochloride)
1 gm or 2 gm mixed with autogenous cancellous bone graft

Active Comparator: Without Vancomycin (NV Group) Drug: without U-VANCO (vancomycin hydrochloride)
no vancomycin added




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883022


Contacts
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Contact: Shih-Tien Wang, MD 886-2-28757557 ext 9 stwang@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Shih-Tien Wang, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Chair: Shih-Tien Wang, MD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03883022     History of Changes
Other Study ID Numbers: 2017-10-008A
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Deep surgical site infection
Vancomycin-impregnated bone graft
Spine surgery
Degenerative lumbar disorder
Additional relevant MeSH terms:
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Vancomycin
Infection
Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Anti-Bacterial Agents
Anti-Infective Agents