- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299882
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
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
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Spectrum Health Hospitals
-
Contact:
- Nichole Rodrique
- Phone Number: 616-258-3886
- Email: Nichole.Rodrique@spectrumhealth.org
-
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
16 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
|
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
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
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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