Wound Infection Clinical Trial
Official title:
Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma
Verified date | October 2013 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to study how well using a powdered form of the antibiotic,
vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented
spinal surgery for traumatic injury to the back.
Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating
certain kinds of bacteria. It is also used to prevent infections of the surgery site.
This will be a study in which the experimental treatment is compared to a standard (control)
treatment. It will be prospective in nature, meaning that it will follow patients forward in
time, and it will consist of a randomization process to determine who will receive the
experimental treatment versus the standard (control) treatment.
The study will take place at Regional Medical Center (The MED). 140 subjects will be
participating in this study.
The investigators hypothesize that the topical use of powder vancomycin will decrease the
rate of surgical site infection.
Status | Enrolling by invitation |
Enrollment | 140 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Hemodynamically stable - 18 years of age or older - Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury Exclusion Criteria: - Septic patient - Open or penetrating spinal injury - Active infection - Active cancer - Known allergy to vancomycin - Previous surgery in surgical site - History of radiation therapy at surgical site - Immunosuppressed (disease or drug-induced) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Regional Medical Center (The MED) | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee | Semmes-Murphey Foundation |
United States,
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. — View Citation
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. — View Citation
Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. German. — View Citation
Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Gold HS, Moellering RC Jr. Antimicrobial-drug resistance. N Engl J Med. 1996 Nov 7;335(19):1445-53. Review. — View Citation
Hanssen AD. Local antibiotic delivery vehicles in the treatment of musculoskeletal infection. Clin Orthop Relat Res. 2005 Aug;(437):91-6. Review. — View Citation
Holtom PD, Pavkovic SA, Bravos PD, Patzakis MJ, Shepherd LE, Frenkel B. Inhibitory effects of the quinolone antibiotics trovafloxacin, ciprofloxacin, and levofloxacin on osteoblastic cells in vitro. J Orthop Res. 2000 Sep;18(5):721-7. — View Citation
Hou T, Xu J, Li Q, Feng J, Zen L. In vitro evaluation of a fibrin gel antibiotic delivery system containing mesenchymal stem cells and vancomycin alginate beads for treating bone infections and facilitating bone formation. Tissue Eng Part A. 2008 Jul;14(7):1173-82. doi: 10.1089/ten.tea.2007.0159. — View Citation
Isefuku S, Joyner CJ, Simpson AH. Gentamicin may have an adverse effect on osteogenesis. J Orthop Trauma. 2003 Mar;17(3):212-6. — View Citation
Isefuku S, Joyner CJ, Simpson AH. Toxic effect of rifampicin on human osteoblast-like cells. J Orthop Res. 2001 Sep;19(5):950-4. — View Citation
Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. — View Citation
Klemm KW. Antibiotic bead chains. Clin Orthop Relat Res. 1993 Oct;(295):63-76. — View Citation
Levi AD, Dickman CA, Sonntag VK. Management of postoperative infections after spinal instrumentation. J Neurosurg. 1997 Jun;86(6):975-80. — View Citation
Martin C, Viviand X, Potié F. Local antibiotic prophylaxis in surgery. Infect Control Hosp Epidemiol. 1996 Aug;17(8):539-44. Review. — View Citation
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. — View Citation
Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. — View Citation
Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Site Infection | All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection. A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons. | 12 Months | No |
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