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

Not Applicable

Recruiting

• Conditions: Spinal Fusion; Spinal Stenosis; Spondylolisthesis
• Interventions: Drug: with U-VANCO (vancomycin hydrochloride); Drug: without U-VANCO (vancomycin hydrochloride)

• Registration Number: NCT03883022
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-03
• Status Verified: 2019-03
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Primary Completion: 2027-09-12
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin (V Group)	with U-VANCO (vancomycin hydrochloride)	-
Without Vancomycin (NV Group)	without U-VANCO (vancomycin hydrochloride)	-

Primary Outcome Measures

Name	Time	Method
Bony fusion status	Post-operative 1 year	The bony fusion status (Lenke criteria)
Functional outcomes	Post-operative 1 year	Functional outcomes, oswestry disability index (ODI)

Secondary Outcome Measures

Name	Time	Method
Vancomycin concentration	Post-operative days 3	Vancomycin concentration was checked for both the serum and drainage.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan