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

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Site Infection

Intervention: Vancomycin powder (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Vanderbilt University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Determine efficacy of using local vancomycin powder

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Sheyan J Armaghani, MD, Phone: 352-318-3235, Email: sheyan.armaghani@vanderbilt.edu
Sheyan J Armaghani, MD, Principal Investigator
Additional Information

Related publications:

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Branstetter JG, Jackson SR, Haggard WO, Richelsoph KC, Wenke JC. Locally-administered antibiotics in wounds in a limb. J Bone Joint Surg Br. 2009 Aug;91(8):1106-9. doi: 10.1302/0301-620X.91B8.22216.

Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. German.

Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7.

Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.

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O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, Devin CJ. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder. Spine J. 2011 Jul;11(7):641-6. doi: 10.1016/j.spinee.2011.04.025. Epub 2011 May 19.

Starting date: June 2012
Last updated: December 8, 2014

Page last updated: August 23, 2015

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