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Recruiting NCT03883022

NCT03883022 Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery

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Clinical Trial Summary
NCT ID NCT03883022
Status Recruiting
Phase
Sponsor Taipei Veterans General Hospital, Taiwan
Condition Spinal Fusion
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2018-09-03
Primary Completion 2027-09-12

Eligibility & Interventions

Sex All sexes
Min Age 20 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
with U-VANCO (vancomycin hydrochloride)without U-VANCO (vancomycin hydrochloride)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2018-09-03 with a primary completion date of 2027-09-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Shih-Tien Wang, MD

✉ stwang@vghtpe.gov.tw

📞 886-2-28757557

Principal Investigator

Shih-Tien Wang, MD

STUDY CHAIR

Taipei Veterans General Hospital, Taiwan

Frequently Asked Questions

Who can join the NCT03883022 clinical trial?

This trial is open to participants of all sexes, aged 20 Years or older, studying Spinal Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03883022 currently recruiting?

Yes, NCT03883022 is actively recruiting participants. Contact the research team at stwang@vghtpe.gov.tw for enrollment information.

Where is the NCT03883022 trial being conducted?

This trial is being conducted at Taipei, Taiwan.

Who is sponsoring the NCT03883022 clinical trial?

NCT03883022 is sponsored by Taipei Veterans General Hospital, Taiwan. The principal investigator is Shih-Tien Wang, MD at Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 400 participants.

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