Vancomycin in Spine Surgery

Wound Infection Clinical Trial

Official title:

Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01977989
• Other study ID #: 13-02478-FB
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: November 6, 2013
• Start date: October 2013
• Est. completion date: October 2015

Study information

• 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

Clinical Trial Summary

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.

Description:

1. Purpose: The purpose of this study is to examine the efficacy of prophylactic, locally applied vancomycin powder against surgical site infection in patients undergoing posterior instrumented spinal surgery for traumatic injury.

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.

Recruitment information / eligibility

• 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)

Study Design

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

Related Conditions & MeSH terms

• Wound Infection

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Regional Medical Center (The MED)	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Semmes-Murphey Foundation

Country where clinical trial is conducted

United States, 

References & Publications (23)

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

Outcome

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