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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883022
• Other study ID #: 2017-10-008A
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Shih-Tien Wang, MD
• Phone: 886-2-28757557
• Email: stwang[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: September 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Spinal Fusion
• Spinal Stenosis
• Spondylolisthesis

Intervention

Drug:
• with U-VANCO (vancomycin hydrochloride)
1 gm or 2 gm mixed with autogenous cancellous bone graft
• without U-VANCO (vancomycin hydrochloride)
no vancomycin added

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bony fusion status	The bony fusion status (Lenke criteria)	Post-operative 1 month
Primary	Bony fusion status	The bony fusion status (Lenke criteria)	Post-operative 3 months
Primary	Bony fusion status	The bony fusion status (Lenke criteria)	Post-operative 6 months
Primary	Bony fusion status	The bony fusion status (Lenke criteria)	Post-operative 1 year
Primary	Functional outcomes	Functional outcomes, visual analogue scale (VAS)	Post-operative 1 month
Primary	Functional outcomes	Functional outcomes, visual analogue scale (VAS)	Post-operative 3 months
Primary	Functional outcomes	Functional outcomes, visual analogue scale (VAS)	Post-operative 6 months
Primary	Functional outcomes	Functional outcomes,visual analogue scale (VAS)	Post-operative 1 year
Primary	Functional outcomes	Functional outcomes,oswestry disability index (ODI)	Post-operative 1 months
Primary	Functional outcomes	Functional outcomes, oswestry disability index (ODI)	Post-operative 3 months
Primary	Functional outcomes	Functional outcomes, oswestry disability index (ODI)	Post-operative 6 months
Primary	Functional outcomes	Functional outcomes, oswestry disability index (ODI)	Post-operative 1 year
Secondary	Vancomycin concentration	Vancomycin concentration was checked for both the serum and drainage.	Post-operative days 1
Secondary	Vancomycin concentration	Vancomycin concentration was checked for both the serum and drainage.	Post-operative days 3