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

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ClinicalTrials.gov Identifier: NCT02299882
Recruitment Status : Unknown
Verified February 2013 by Jason A Squires, DO, Spectrum Health Hospitals.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Jason A Squires, DO, Spectrum Health Hospitals

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

Condition or disease Intervention/treatment Phase
Lumbar Pain Drug: Vancomycin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
Study Start Date : August 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Surgical wound infection rate, both deep and superficial infections [ Time Frame: 12 weeks post surgery ]

Secondary Outcome Measures :
  1. Post-operative rate of MRSA infections. [ Time Frame: 12 weeks post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299882


Locations
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United States, Michigan
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Nichole Rodrique    616-258-3886    Nichole.Rodrique@spectrumhealth.org   
Principal Investigator: Jason Squires, DO         
Sub-Investigator: Sanja Patra, MD         
Sub-Investigator: Marilyn Gates, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Jason Squires, DO Spectrum Health Hospitals

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Responsible Party: Jason A Squires, DO, Physician, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02299882     History of Changes
Other Study ID Numbers: 2012-166
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: February 2013
Keywords provided by Jason A Squires, DO, Spectrum Health Hospitals:
Posterior spine surgery
infection
vancomycin
surgical wound infection
Additional relevant MeSH terms:
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Infection
Anti-Bacterial Agents
Vancomycin
Anti-Infective Agents