Intrawound Vancomycin Powder in Spinal Fusion 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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-03-01

Brief Summary

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Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in spinal fusion surgery. The powder will be locally administered into to the wound cavity before wound closure.

Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical site infections

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Detailed Description

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Vancomycin is being widely used as an antibiotic agent for intravenous and topical use. The surgical application of vancomycin powder in Austria is limited as there is no powder with marketing authorization for intraoperative, intrawound usage. Previous reports widely document the application of vancomycin powder for solution for infusion. The powder is not soluted, but instead directly spread throughout the wound surface. Limited data is available for spinal fusion surgery, mostly retrospective studies. Results were promising, but the low evidence level does not allow for a conclusion regarding routine usage. Additional randomized, controlled trials are necessary to further investigate this matter.

This trial aims to investigate Vancomycin powder "Xellia" 1000mg, which has a Marketing authorization, in an off-label usage (intrawound, intraoperatively) in spinal fusion surgery. The investigational medicinal product will be used unmodified.

Conditions

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Spinal Fusion Acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

No additional treatment. Routine iv. antibiotic prophylaxis only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Vancomycin Group

Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Locally, intrawound applied vancomycin powder

Interventions

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Vancomycin

Locally, intrawound applied vancomycin powder

Intervention Type DRUG

Other Intervention Names

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Vancomycin Hydrochloride, Powder for Solution for Infusion

Eligibility Criteria

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Inclusion Criteria

* Planned TLIF (transforaminal lumbar interbody fusion) or PLIF (posterolateral lumbar interbody fusion) surgery
* TLIF/PLIF fusion length of one or two motion-segments OR
* One motion-segment TLIF/PLIF in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy)
* Fusions within L1 (first lumbar vertebra) through S1 (sacrum)
* Age of 18-years or older
* Signed informed consent

Exclusion Criteria

* Preoperative inflammatory or infectious state (C-reactive protein levels above 10mg/l)
* Allergic to vancomycin, teicoplanin or penicillin
* Preexisting auto-immune disease with an impaired immune system
* Current post-traumatic vertebral injury (e.g. vertebral split fracture)
* Preexisting Renal impairment
* Preexisting cochlea damage
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No