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

Not Applicable

• Conditions: Lumbar Pain
• Interventions: Drug: Vancomycin

• Registration Number: NCT02299882
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2014-11-21
• Last Update Submitted: 2014-11-21
• Study First Posted: 2014-11-24
• Last Update Posted: 2014-11-24
• Primary Completion: 2015-08
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Surgical wound infection rate, both deep and superficial infections	12 weeks post surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative rate of MRSA infections.	12 weeks post surgery

Trial Locations

Locations (1)

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States