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

November 21, 2014 updated by: Jason A Squires, DO, Spectrum Health Hospitals
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health Hospitals
        • Contact:
        • Principal Investigator:
          • Jason Squires, DO
        • Sub-Investigator:
          • Sanja Patra, MD
        • Sub-Investigator:
          • Marilyn Gates, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vancomycin
Patient will receive Vancomycin powder to the incision just before skin closure
Drug: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical wound infection rate, both deep and superficial infections
Time Frame: 12 weeks post surgery
12 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative rate of MRSA infections.
Time Frame: 12 weeks post surgery
12 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Investigators

  • Principal Investigator: Jason Squires, DO, Spectrum Health Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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