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

Primary Purpose

Lumbar Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lumbar Pain focused on measuring Posterior spine surgery, infection, vancomycin, surgical wound infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spectrum Health HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vancomycin

no vancomycin

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Surgical wound infection rate, both deep and superficial infections

Secondary Outcome Measures

Post-operative rate of MRSA infections.

Full Information

First Posted
February 20, 2013
Last Updated
November 21, 2014
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02299882
Brief Title
Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
Official Title
Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Pain
Keywords
Posterior spine surgery, infection, vancomycin, surgical wound infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
Patient will receive Vancomycin powder to the incision just before skin closure
Arm Title
no vancomycin
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical wound infection rate, both deep and superficial infections
Time Frame
12 weeks post surgery
Secondary Outcome Measure Information:
Title
Post-operative rate of MRSA infections.
Time Frame
12 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Squires, DO
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Rodrique
Phone
616-258-3886
Email
Nichole.Rodrique@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Jason Squires, DO
First Name & Middle Initial & Last Name & Degree
Sanja Patra, MD
First Name & Middle Initial & Last Name & Degree
Marilyn Gates, MD

12. IPD Sharing Statement

Learn more about this trial

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

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