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

March 18, 2019 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Shih-Tien Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bony fusion status
Time Frame: Post-operative 1 month
The bony fusion status (Lenke criteria)
Post-operative 1 month
Bony fusion status
Time Frame: Post-operative 3 months
The bony fusion status (Lenke criteria)
Post-operative 3 months
Bony fusion status
Time Frame: Post-operative 6 months
The bony fusion status (Lenke criteria)
Post-operative 6 months
Bony fusion status
Time Frame: Post-operative 1 year
The bony fusion status (Lenke criteria)
Post-operative 1 year
Functional outcomes
Time Frame: Post-operative 1 month
Functional outcomes, visual analogue scale (VAS)
Post-operative 1 month
Functional outcomes
Time Frame: Post-operative 3 months
Functional outcomes, visual analogue scale (VAS)
Post-operative 3 months
Functional outcomes
Time Frame: Post-operative 6 months
Functional outcomes, visual analogue scale (VAS)
Post-operative 6 months
Functional outcomes
Time Frame: Post-operative 1 year
Functional outcomes,visual analogue scale (VAS)
Post-operative 1 year
Functional outcomes
Time Frame: Post-operative 1 months
Functional outcomes,oswestry disability index (ODI)
Post-operative 1 months
Functional outcomes
Time Frame: Post-operative 3 months
Functional outcomes, oswestry disability index (ODI)
Post-operative 3 months
Functional outcomes
Time Frame: Post-operative 6 months
Functional outcomes, oswestry disability index (ODI)
Post-operative 6 months
Functional outcomes
Time Frame: Post-operative 1 year
Functional outcomes, oswestry disability index (ODI)
Post-operative 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancomycin concentration
Time Frame: Post-operative days 1
Vancomycin concentration was checked for both the serum and drainage.
Post-operative days 1
Vancomycin concentration
Time Frame: Post-operative days 3
Vancomycin concentration was checked for both the serum and drainage.
Post-operative days 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Chair: Shih-Tien Wang, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2018

Primary Completion (ANTICIPATED)

September 12, 2027

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-10-008A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Stenosis

Clinical Trials on with U-VANCO (vancomycin hydrochloride)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe