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

Taipei Veterans General Hospital, Taiwan400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

400

Conditions

Spinal Fusion Spinal Stenosis Spondylolisthesis

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame: Post-operative 1 month

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame: Post-operative 3 months

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame: Post-operative 6 months

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame: Post-operative 1 year

Functional outcomes

Functional outcomes, visual analogue scale (VAS)

Time frame: Post-operative 1 month

Functional outcomes

Functional outcomes, visual analogue scale (VAS)

Time frame: Post-operative 3 months

Functional outcomes

Functional outcomes, visual analogue scale (VAS)

Time frame: Post-operative 6 months

Functional outcomes

Functional outcomes,visual analogue scale (VAS)

Time frame: Post-operative 1 year

Functional outcomes

Functional outcomes,oswestry disability index (ODI)

Time frame: Post-operative 1 months

Functional outcomes

Functional outcomes, oswestry disability index (ODI)

Time frame: Post-operative 3 months

Functional outcomes

Functional outcomes, oswestry disability index (ODI)

Time frame: Post-operative 6 months

Functional outcomes

Functional outcomes, oswestry disability index (ODI)

Time frame: Post-operative 1 year

Secondary Outcomes

Vancomycin concentration

Vancomycin concentration was checked for both the serum and drainage.

Time frame: Post-operative days 1

Vancomycin concentration

Vancomycin concentration was checked for both the serum and drainage.

Time frame: Post-operative days 3

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts