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

Information source: Spectrum Health Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lumbar Pain

Intervention: Vancomycin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Spectrum Health Hospitals

Official(s) and/or principal investigator(s):
Jason Squires, DO, Principal Investigator, Affiliation: Spectrum Health Hospitals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Surgical wound infection rate, both deep and superficial infections

Secondary outcome: Post-operative rate of MRSA infections.

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Spectrum Health Hospitals, Grand Rapids, Michigan 49503, United States; Recruiting
Nichole Rodrique, Phone: 616-258-3886, Email: Nichole.Rodrique@spectrumhealth.org
Jason Squires, DO, Principal Investigator
Sanja Patra, MD, Sub-Investigator
Marilyn Gates, MD, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: November 21, 2014

Page last updated: August 23, 2015

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