Spinal FusionNCT03883022
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
A study testing with U-VANCO (vancomycin hydrochloride) and without U-VANCO (vancomycin hydrochloride) in people with Spinal Fusion and Spinal Stenosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Fusion, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- with U-VANCO (vancomycin hydrochloride) and without U-VANCO (vancomycin hydrochloride)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Sep 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who agree to accept the spine surgery but do not agree to sign the inform consent
- Patients who have allergic reaction to vancomycin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Shih-Tien Wang, MD
About this study
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.
- Conditions
- Spinal Fusion, Spinal Stenosis, Spondylolisthesis
- Being tested
- with U-VANCO (vancomycin hydrochloride), without U-VANCO (vancomycin hydrochloride)
- Keywords
- Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin (V Group) | Experimental | Not described Receives: Drug: with U-VANCO (vancomycin hydrochloride) |
| Without Vancomycin (NV Group) | Active comparator | Not described Receives: Drug: without U-VANCO (vancomycin hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bony fusion status
The bony fusion status (Lenke criteria)
Measured: Post-operative 1 month
Bony fusion status
The bony fusion status (Lenke criteria)
Measured: Post-operative 3 months
Bony fusion status
The bony fusion status (Lenke criteria)
Measured: Post-operative 6 months
Bony fusion status
The bony fusion status (Lenke criteria)
Measured: Post-operative 1 year
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Measured: Post-operative 1 month
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Measured: Post-operative 3 months
Functional outcomes
Functional outcomes, visual analogue scale (VAS)
Measured: Post-operative 6 months
Functional outcomes
Functional outcomes,visual analogue scale (VAS)
Measured: Post-operative 1 year
Functional outcomes
Functional outcomes,oswestry disability index (ODI)
Measured: Post-operative 1 months
Functional outcomes
Functional outcomes, oswestry disability index (ODI)
Measured: Post-operative 3 months
Functional outcomes
Functional outcomes, oswestry disability index (ODI)
Measured: Post-operative 6 months
Functional outcomes
Functional outcomes, oswestry disability index (ODI)
Measured: Post-operative 1 year
Secondary outcomes (2)
Vancomycin concentration
Vancomycin concentration was checked for both the serum and drainage.
Measured: Post-operative days 1
Vancomycin concentration
Vancomycin concentration was checked for both the serum and drainage.
Measured: Post-operative days 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start3 Sep 2018
- Primary completion12 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shih-Tien Wang, MD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883022
- Sponsor's protocol ID
- 2017-10-008A
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang ST, Lin HH, Yao YC, Huang N, Hsiung W, Chang MC, Liu CL, Chou PH. Vancomycin powder mixed with autogenous bone graft and bone substitute may decrease the deep surgical site infections in elective lumbar instrumented fusion surgery for degenerative disorders: a prospective randomized study. Spine J. 2025 Sep;25(9):1866-1876. doi: 10.1016/j.spinee.2025.05.001. Epub 2025 May 5.
PubMed 40334989
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
- ClinicalTrials.gov ID
- NCT03883022
- Acronym / sponsor ID
- 2017-10-008A
- Conditions
- Spinal Fusion, Spinal Stenosis, Spondylolisthesis
- Keywords
- Deep surgical site infection, Vancomycin-impregnated bone graft, Spine surgery, Degenerative lumbar disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 12 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin (V Group) | Experimental | Drug: with U-VANCO (vancomycin hydrochloride) |
| Without Vancomycin (NV Group) | Active comparator | Drug: without U-VANCO (vancomycin hydrochloride) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who agree to accept the spine surgery but do not agree to sign the inform consent
- Patients who have allergic reaction to vancomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with U-VANCO (vancomycin hydrochloride)1 gm or 2 gm mixed with autogenous cancellous bone graft | Drug | Vancomycin (V Group) |
| without U-VANCO (vancomycin hydrochloride)no vancomycin added | Drug | Without Vancomycin (NV Group) |
Primary outcome
Bony fusion status
Time frame: Post-operative 1 month
The bony fusion status (Lenke criteria)
Bony fusion status
Time frame: Post-operative 3 months
The bony fusion status (Lenke criteria)
Bony fusion status
Time frame: Post-operative 6 months
The bony fusion status (Lenke criteria)
Bony fusion status
Time frame: Post-operative 1 year
The bony fusion status (Lenke criteria)
Functional outcomes
Time frame: Post-operative 1 month
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Time frame: Post-operative 3 months
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Time frame: Post-operative 6 months
Functional outcomes, visual analogue scale (VAS)
Functional outcomes
Time frame: Post-operative 1 year
Functional outcomes,visual analogue scale (VAS)
Functional outcomes
Time frame: Post-operative 1 months
Functional outcomes,oswestry disability index (ODI)
Functional outcomes
Time frame: Post-operative 3 months
Functional outcomes, oswestry disability index (ODI)
Functional outcomes
Time frame: Post-operative 6 months
Functional outcomes, oswestry disability index (ODI)
Functional outcomes
Time frame: Post-operative 1 year
Functional outcomes, oswestry disability index (ODI)
2 secondary outcomes
Vancomycin concentration
Time frame: Post-operative days 1
Vancomycin concentration
Time frame: Post-operative days 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Derived from this study: PubMed 40334989Wang ST, Lin HH, Yao YC, Huang N, Hsiung W, Chang MC, Liu CL, Chou PH. Vancomycin powder mixed with autogenous bone graft and bone substitute may decrease the deep surgical site infections in elective lumbar instrumented fusion surgery for degenerative disorders: a prospective randomized study. Spine J. 2025 Sep;25(9):1866-1876. doi: 10.1016/j.spinee.2025.05.001. Epub 2025 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shih-Tien Wang, MD study chair
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with U-VANCO (vancomycin hydrochloride) and without U-VANCO (vancomycin hydrochloride) in people with Spinal Fusion and Spinal Stenosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Tien Wang, MD (886-2-28757557 ext. 9, stwang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bony fusion status (time frame: Post-operative 1 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.