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

This study is not yet open for participant recruitment.
Verified March 2012 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Sheyan Armaghani, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01566422
First received: March 12, 2012
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Surgical Site Infection
 Drug: Vancomycin powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Determine efficacy of using local vancomycin powder [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 160
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566422

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet 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
Study First Received: March 12, 2012
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013