Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics

NCT ID: NCT02299882

Last Updated: 2014-11-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-01-31

Brief Summary

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Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.

Detailed Description

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Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.

Conditions

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Lumbar Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vancomycin

Patient will receive Vancomycin powder to the incision just before skin closure

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.

no vancomycin

Patient will be randomized to either vancomycin powder or no vancomycin powder. This arm the patient will not have the powder placed in the incision before skin closure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vancomycin

Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All adult, 18 years or greater undergoing posterior approach spinal surgery

Exclusion Criteria

* Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity.
* patients with known reaction to Vancomycin.
* patients having surgery specifically for spine infection
* patients having ADCF or ALIF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Jason A Squires, DO

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Squires, DO

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

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Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Nichole Rodrique

Role: primary

616-258-3886

Other Identifiers

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2012-166

Identifier Type: -

Identifier Source: org_study_id