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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UNKNOWN
PHASE4
140 participants
INTERVENTIONAL
2013-10-31
2015-10-31
Brief Summary
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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.
Detailed Description
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2. Rationale: Surgical site infection (SSI) is a morbid complication with high cost in management of surgical spine patients. In this era of healthcare reforms, adjuvant therapies that not only improve quality, but also decrease cost, are considered of highest value. Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious perioperative concern. In comparison to systemic antibiotics, local delivery of antibiotics is attractive because high concentrations are achieved directly at these sites and systemic toxicity is limited.
Prior investigations have primarily focused on the treatment of infected wounds with local antibiotics. Only a few studies have analyzed prophylactic use of local antibiotics during spine surgery. To date, there are no prospective, randomized studies on the prophylactic use of local antibiotics. The investigators will introduce local vancomycin powder into their practice of instrumented posterior spinal fusion for traumatic spine injury and determine efficacy in preventing postoperative infections.
3. Study Population: The study will consist of adult patients undergoing posterior, instrumented spine surgery for traumatic injury.
4. Research Design: This will be a prospective, randomized, controlled trial. The study will primarily be carried out through the University of Tennessee Health Science Center with all spinal surgery taking place at the Regional Medical Center at Memphis. Once patients with traumatic spine injury have been deemed eligible through several other criteria described later in the application, they will be placed into one of two randomized groups:
1\) The control group will consist of patients who are administered systemic prophylactic antibiotic only.
2\) The treatment group will consist of patients who are administered systemic prophylactic antibiotic along with vancomycin powder within the surgical site.
5\. Study/Project Procedures: Patients who meet the entry criteria and agree to participate in the trial will be randomized to receive intraoperative vancomycin powder within the surgical wound or not. In all patients, vancomycin 1g and cefazolin 2g IV will be given within 60min of skin incision. If an allergy to cefazolin exists, 900mg of clindamycin IV will be used in its place. Cefazolin 1g IV will be given q6hr during surgery and continued q8hr post surgery for 24hrs, regardless of whether a surgical drain is in place. One to three liters of normal saline will be used for irrigation purposes during surgical procedure. Prior to wound closure, vancomycin powder will be topically applied both above (50% of dose) and below (50% of dose) the deep muscular fascia in patients participating in the treatment arm of the study. For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin (1/2 vial) will be applied. For surgeries involving greater than 3 contiguous spinal segments, 1gm will be applied.
6\. Outcome Measures: All patients will be followed on an inpatient or outpatient basis (as applicable) for a period of 12 months post-operatively. Residents, attendings and study coordinators will perform data collection. All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection (ex. purulent drainage from the incision, erythema and swelling). A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons (pacemaker, metallic foreign bodies, fresh vascular stents, etc.). All wound data will be collected and recorded in specific data forms at each clinical encounter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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No Vancomycin Powder
Patients who only receive IV Vancomycion prior to surgery. No Vancomycin powder is administered.
No interventions assigned to this group
Vancomycin Powder
Patients who receive Vancomycin powder in the surgical site following surgery.
Vancomycin Powder
For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site.
Interventions
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Vancomycin Powder
For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury
Exclusion Criteria
* 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)
18 Years
90 Years
ALL
Yes
Sponsors
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Semmes-Murphey Foundation
OTHER
University of Tennessee
OTHER
Responsible Party
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Locations
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Regional Medical Center (The MED)
Memphis, Tennessee, United States
Countries
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References
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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. doi: 10.3201/eid0902.020232.
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.
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.
Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7. doi: 10.1007/BF01653540. No abstract available.
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.
Isefuku S, Joyner CJ, Simpson AH. Gentamicin may have an adverse effect on osteogenesis. J Orthop Trauma. 2003 Mar;17(3):212-6. doi: 10.1097/00005131-200303000-00010.
Isefuku S, Joyner CJ, Simpson AH. Toxic effect of rifampicin on human osteoblast-like cells. J Orthop Res. 2001 Sep;19(5):950-4. doi: 10.1016/S0736-0266(01)00022-5.
Klemm KW. Antibiotic bead chains. Clin Orthop Relat Res. 1993 Oct;(295):63-76.
Levi AD, Dickman CA, Sonntag VK. Management of postoperative infections after spinal instrumentation. J Neurosurg. 1997 Jun;86(6):975-80. doi: 10.3171/jns.1997.86.6.0975.
Martin C, Viviand X, Potie F. Local antibiotic prophylaxis in surgery. Infect Control Hosp Epidemiol. 1996 Aug;17(8):539-44. doi: 10.1086/647366.
Hanssen AD. Local antibiotic delivery vehicles in the treatment of musculoskeletal infection. Clin Orthop Relat Res. 2005 Aug;(437):91-6. doi: 10.1097/01.blo.0000175713.30506.77.
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. doi: 10.1002/jor.1100180507.
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.
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.
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.
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. doi: 10.1086/501572.
Other Identifiers
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13-02478-FB
Identifier Type: -
Identifier Source: org_study_id