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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03883022
• Date of registration: 10/03/2019
• Prospective Registration: No
• Primary sponsor: Taipei Veterans General Hospital, Taiwan
• Public title: Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
• Scientific title: Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
• Date of first enrolment: September 3, 2018
• Target sample size: 400
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03883022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Shih-Tien Wang, MD

• Name: Shih-Tien Wang, MD
• Affiliation: Taipei Veterans General Hospital, Taiwan

• Name: Shih-Tien Wang, MD

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Fusion

Spondylolisthesis

Spinal Stenosis

Intervention(s)

Drug: without U-VANCO (vancomycin hydrochloride)

Drug: with U-VANCO (vancomycin hydrochloride)

Primary Outcome(s)

Functional outcomes [Time Frame: Post-operative 1 month]

Bony fusion status [Time Frame: Post-operative 3 months]

Bony fusion status [Time Frame: Post-operative 6 months]

Functional outcomes [Time Frame: Post-operative 1 months]

Functional outcomes [Time Frame: Post-operative 3 months]

Functional outcomes [Time Frame: Post-operative 1 year]

Functional outcomes [Time Frame: Post-operative 6 months]

Bony fusion status [Time Frame: Post-operative 1 year]

Bony fusion status [Time Frame: Post-operative 1 month]

Secondary Outcome(s)

Vancomycin concentration [Time Frame: Post-operative days 3]

Vancomycin concentration [Time Frame: Post-operative days 1]

Secondary ID(s)

2017-10-008A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors