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Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients

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ClinicalTrials.gov Identifier: NCT01566422
Recruitment Status : Unknown
Verified December 2014 by Sheyan Armaghani, Vanderbilt University.
Recruitment status was:  Recruiting
First Posted : March 29, 2012
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious concern. The incidence of deep infection after spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of treating such infections is profound. With diminishing healthcare dollars and policy that refuses to reimburse for postoperative infections, it is critical that physicians and hospital systems seek out cost effective ways of decreasing postoperative infections. Local delivery of antibiotics into the surgical site have been found to significantly decrease infection rates in those undergoing posterior spine fusion for traumatic injuries as studied in a retrospective manner by the investigators of this grant. In this proposal the investigators will prospectively randomize patients undergoing posterior spinal stabilization for traumatic injuries into either receiving vancomycin powder into the surgical site (treatment) versus not receiving vancomycin powder (control) and subsequently follow infection rate, complications, and cost of care. The investigator's hypothesis is that i) vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a cost saving advancement in the safety of delivering spine surgical care.

Condition or disease Intervention/treatment
Surgical Site Infection Drug: Vancomycin powder

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Study Start Date : June 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vancomycin powder
80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery.
Drug: Vancomycin powder
patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
No Intervention: Control
80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery.


Outcome Measures

Primary Outcome Measures :
  1. Determine efficacy of using local vancomycin powder [ Time Frame: 2 years ]
    Patient demographics and perioperative information obtained will include: comorbidities known to increase the risk of infection, body mass index, level of injury, presence of neurologic deficit, prealbumin level, evidence of an open fracture elsewhere, injury severity score, operative time, estimated blood loss, and blood creatinine levels. All wounds will be assessed 4-6 weeks after surgery to address early surgical site infection (SSI).


Eligibility Criteria

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

Inclusion Criteria

  • All English-speaking patients ≥ 18 years undergoing posterior spine fusions at Vanderbilt University Medical Center for the treatment of traumatic injuries will be considered for inclusion

Exclusion Criteria

  • have a known allergy to vancomycin
  • do not agree to participate
  • had previous spine surgery at the injury level within 6 months
  • are pregnant
  • have a history of Steven's Johnson Syndrome
  • have a history of infections at the surgical site
  • have a history of cancer or radiation treatment at the injured level
  • have open spine fractures
  • have traumatic injuries to non-spine organ systems that limit their functional capacity
Contacts and Locations

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): NCT01566422


Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sheyan J Armaghani, MD    352-318-3235    sheyan.armaghani@vanderbilt.edu   
Principal Investigator: Sheyan J Armaghani, MD         
Sponsors and Collaborators
Vanderbilt University
More Information

Publications:

Responsible Party: Sheyan Armaghani, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01566422     History of Changes
Other Study ID Numbers: Vanc-1510
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents