- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883022
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
-
-
-
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)
|
1 gm or 2 gm mixed with autogenous cancellous bone graft
|
ACTIVE_COMPARATOR: Without Vancomycin (NV Group)
|
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.
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.
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