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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Fusion Spinal Stenosis Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vancomycin (V Group)

Group Type EXPERIMENTAL

with U-VANCO (vancomycin hydrochloride)

Intervention Type DRUG

1 gm or 2 gm mixed with autogenous cancellous bone graft

Without Vancomycin (NV Group)

Group Type ACTIVE_COMPARATOR

without U-VANCO (vancomycin hydrochloride)

Intervention Type DRUG

no vancomycin added

Interventions

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with U-VANCO (vancomycin hydrochloride)

1 gm or 2 gm mixed with autogenous cancellous bone graft

Intervention Type DRUG

without U-VANCO (vancomycin hydrochloride)

no vancomycin added

Intervention Type DRUG

Eligibility Criteria

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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