search
Back to results

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

Primary Purpose

Spinal Fusion, Spinal Stenosis, Spondylolisthesis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
with U-VANCO (vancomycin hydrochloride)
without U-VANCO (vancomycin hydrochloride)
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Fusion focused on measuring Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vancomycin (V Group)

Without Vancomycin (NV Group)

Arm Description

Outcomes

Primary Outcome Measures

Bony fusion status
The bony fusion status (Lenke criteria)
Bony fusion status
The bony fusion status (Lenke criteria)
Bony fusion status
The bony fusion status (Lenke criteria)
Bony fusion status
The bony fusion status (Lenke criteria)
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Functional outcomes,visual analogue scale (VAS)
Functional outcomes
Functional outcomes,oswestry disability index (ODI)
Functional outcomes
Functional outcomes, oswestry disability index (ODI)
Functional outcomes
Functional outcomes, oswestry disability index (ODI)
Functional outcomes
Functional outcomes, oswestry disability index (ODI)

Secondary Outcome Measures

Vancomycin concentration
Vancomycin concentration was checked for both the serum and drainage.
Vancomycin concentration
Vancomycin concentration was checked for both the serum and drainage.

Full Information

First Posted
March 10, 2019
Last Updated
March 18, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT03883022
Brief Title
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Official Title
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
September 12, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fusion, Spinal Stenosis, Spondylolisthesis
Keywords
Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin (V Group)
Arm Type
Experimental
Arm Title
Without Vancomycin (NV Group)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
with U-VANCO (vancomycin hydrochloride)
Intervention Description
1 gm or 2 gm mixed with autogenous cancellous bone graft
Intervention Type
Drug
Intervention Name(s)
without U-VANCO (vancomycin hydrochloride)
Intervention Description
no vancomycin added
Primary Outcome Measure Information:
Title
Bony fusion status
Description
The bony fusion status (Lenke criteria)
Time Frame
Post-operative 1 month
Title
Bony fusion status
Description
The bony fusion status (Lenke criteria)
Time Frame
Post-operative 3 months
Title
Bony fusion status
Description
The bony fusion status (Lenke criteria)
Time Frame
Post-operative 6 months
Title
Bony fusion status
Description
The bony fusion status (Lenke criteria)
Time Frame
Post-operative 1 year
Title
Functional outcomes
Description
Functional outcomes, visual analogue scale (VAS)
Time Frame
Post-operative 1 month
Title
Functional outcomes
Description
Functional outcomes, visual analogue scale (VAS)
Time Frame
Post-operative 3 months
Title
Functional outcomes
Description
Functional outcomes, visual analogue scale (VAS)
Time Frame
Post-operative 6 months
Title
Functional outcomes
Description
Functional outcomes,visual analogue scale (VAS)
Time Frame
Post-operative 1 year
Title
Functional outcomes
Description
Functional outcomes,oswestry disability index (ODI)
Time Frame
Post-operative 1 months
Title
Functional outcomes
Description
Functional outcomes, oswestry disability index (ODI)
Time Frame
Post-operative 3 months
Title
Functional outcomes
Description
Functional outcomes, oswestry disability index (ODI)
Time Frame
Post-operative 6 months
Title
Functional outcomes
Description
Functional outcomes, oswestry disability index (ODI)
Time Frame
Post-operative 1 year
Secondary Outcome Measure Information:
Title
Vancomycin concentration
Description
Vancomycin concentration was checked for both the serum and drainage.
Time Frame
Post-operative days 1
Title
Vancomycin concentration
Description
Vancomycin concentration was checked for both the serum and drainage.
Time Frame
Post-operative days 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Tien Wang, MD
Phone
886-2-28757557
Ext
9
Email
stwang@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Tien Wang, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shih-Tien Wang, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs