Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
NCT ID: NCT01566422
Last Updated: 2018-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vancomycin powder
80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery.
Vancomycin powder
patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
Control
80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery.
No interventions assigned to this group
Interventions
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Vancomycin powder
patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Bibbo C, Patel DV. The effect of demineralized bone matrix-calcium sulfate with vancomycin on calcaneal fracture healing and infection rates: a prospective study. Foot Ankle Int. 2006 Jul;27(7):487-93. doi: 10.1177/107110070602700702.
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. No abstract available. German.
Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7. doi: 10.1007/BF01653540. No abstract available.
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.
Cavanaugh DL, Berry J, Yarboro SR, Dahners LE. Better prophylaxis against surgical site infection with local as well as systemic antibiotics. An in vivo study. J Bone Joint Surg Am. 2009 Aug;91(8):1907-12. doi: 10.2106/JBJS.G.01237.
Dahners LE, Funderburk CH. Gentamicin-loaded plaster of Paris as a treatment of experimental osteomyelitis in rabbits. Clin Orthop Relat Res. 1987 Jun;(219):278-82.
Edin ML, Miclau T, Lester GE, Lindsey RW, Dahners LE. Effect of cefazolin and vancomycin on osteoblasts in vitro. Clin Orthop Relat Res. 1996 Dec;(333):245-51.
Gitelis S, Brebach GT. The treatment of chronic osteomyelitis with a biodegradable antibiotic-impregnated implant. J Orthop Surg (Hong Kong). 2002 Jun;10(1):53-60. doi: 10.1177/230949900201000110.
Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.
Gold HS, Moellering RC Jr. Antimicrobial-drug resistance. N Engl J Med. 1996 Nov 7;335(19):1445-53. doi: 10.1056/NEJM199611073351907. No abstract available.
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.
Other Identifiers
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Vanc-1510
Identifier Type: -
Identifier Source: org_study_id
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