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NASS 32nd Annual Meeting Proceedings / The Spine Journal 17 (2017) S111–S165
PURPOSE: Using an established in vivo mouse model of spine implant infection, we aim to evaluate whether combination therapy with vancomycin plus rifampin has increased efficacy compared with vancomycin alone. STUDY DESIGN/SETTING: Randomized control experiment utilizing a mouse model of spine implant infection to test systemic antibiotics against biofilm infections. PATIENT SAMPLE: Not applicable. OUTCOME MEASURES: (1) Bioluminescence representative of bacterial burden; (2) colony forming units (CFU) of bacteria cultured from the implant/wound bed after experiment is complete. METHODS: A mouse model of spinal surgery was used in which an L-shaped, stainless steel Kirschner-wire was transfixed into the L4 spinous processes. The implant was inoculated with a bioluminescent Staphylococcus aureus. Mice were randomized into a vancomycin, combination with vancomycin plus rifampin, or control group receiving sterile saline. Antibiotic and sham injections began on POD7 to allow biofilm formation and continued through POD14. In vivo imaging over 5 weeks was performed using bioluminescence imaging. CFUs were cultured from the implant and surrounding tissues on POD35 to verify infection. RESULTS: Bacterial bioluminescence peaked at POD7 for all groups. The combination group had nearly a 10-fold decrease in bioluminescent signal by POD10. The vancomycin and control groups did not reach similar levels until POD17 and 21, respectively. On POD25 the combination group dropped below baseline, but then rebounded to the same level as vancomycin and control groups. CFUs collected from the implant at POD35 confirmed persistent infection. CONCLUSIONS: These data suggest that combination antibiotic therapy causes an initial rapid decline in bacterial burden in the setting of an implant infection. However, when studying the natural course of infection to POD35, combination antibiotic therapy did not eradicate infection. This study lends evidence toward the inability of systemic antibiotic therapy to completely eradicate an implant infection and suggests alternative biofilm modifying agents are required. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.251
203. Vancomycin Powder in Spine Surgery: Does It Work and Does Dose Matter? An In Vivo Mouse Model Experiment Howard Y. Park, MD1, William Sheppard, BS2, Vishal Hegde, MD3, Stephen Zoller, MD1, Marina Sprague, MS2, Ryan Smith, BS4, Nicholas Bernthal, MD5; 1Department of Orthopaedic Surgery, UCLA Medical Center, Los Angeles, CA, USA; 2Los Angeles, CA, USA; 3 Department of Orthopaedic Surgery, UCLA, Los Angeles, CA, USA; 4 Bernthal Lab, Los Angeles, CA, USA; 5UCLA, Santa Monica, CA, USA BACKGROUND CONTEXT: Postoperative spine infections, whether early or late onset, are devastating complications to patients necessitating multimodal treatment and imposing significant morbidity. A variety of strategies are employed to prevent such infections, including the use of vancomycin powder prior to operative closure. This strategy is based on the finding that Staphylococcus aureus represents the most prevalent causative organism in spine surgical site infections. The promise and effect of vancomycin powder (VP) in preventing spine infection has been suggested within the clinical literature, but high-level controlled clinical studies and basic science studies with regard to the efficacy of this practice are scarce. PURPOSE: The purpose of this experiment is to test the efficacy and dose of vancomycin powder within a novel, in vivo mouse model of spinal infection. STUDY DESIGN/SETTING: This is a basic science experiment utilizing an established, novel mouse model of spine implant infection inoculated with bioluminescent Staphylococcus aureus for longitudinal quantification of bacterial burden. Prior to closure of the wound, mice were randomized to intrawound VP application vs no VP. PATIENT SAMPLE: Twenty-eight JAX mice were utilized in this experiment: 4 sterile controls, 4 sterile controls with VP, 10 inoculated implants
within mice without VP treatment, and 10 inoculated implants within mice with VP treatment. OUTCOME MEASURES: Utilizing an established mouse model of spinal implant infection, in vivo bioluminescence imaging was performed using an IVIS Lumina II (PerkinElmer, Hopkinton, MA) on POD 0, 1, 3, 5, 7, 10, 14, 18, 21, 25, and 35 to quantify bacterial burden over time. CFU analysis was also completed at the conclusion. METHODS: The in vivo efficacy of VP was tested using an established mouse model of spinal implant infection in which bioluminescent Staphycoccus aureus were inoculated on implants surgically inserted into the L4 spinous processes. Prior to closure, mice were randomized to treatment with intra-wound VP or no VP. The standard dose was determined upon the vancomycin dosing for humans (15 mg/kg), which was converted to dosing for mice according to established surface area dosing conversion factors. In addition, the experiment was repeated with double and half the standard dose. RESULTS: Beginning on day 1, the bioluminescence levels of the control group without VP treatment matched our historical controls confirming a robust infection. On every date of bioluminescent imaging, the infected group without VP treatment exhibited significantly higher levels of bioluminescence when compared to the treatment group with VP administration. The VP treatment group exhibited bioluminescence levels indistinguishable from the sterile control group and sterile control group with vancomycin powder treatment. This suppression of bioluminescence was also seen with half and double the dose of VP. CONCLUSIONS: Vancomycin powder has the ability to control acute infection in the postoperative period within this in vivo model of spine implant infection. Furthermore, the dose, when reduced in half, was efficacious, perhaps questioning the current standards of dosing. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.252
204. Prophylactic Use of Intraoperative Vancomycin Powder and Postoperative Infection: An Analysis of Microbiological Patterns in 1,200 Consecutive Surgical Cases Owoicho Adogwa, MD, MPH1, Aladine A. Elsamadicy, BS2, Amanda Sergesketter, BS3, Victoria D. Vuong, MSc, BS4, Syed I. Khalid, BS5, Ankit Mehta, MD6, Raul A. Vasquez-Castellanos, MD7, Joseph S. Cheng, MD, MS8, Carlos A. Bagley, MD9, Isaac O. Karikari, MD10; 1Rush University Medical Center, Chicago, IL, USA; 2Duke School of Medicine, Durham, NC, USA; 3Durham, NC, USA; 4Chicago, IL, USA; 5Chicago Medical School, North Chicago, IL, USA; 6University of Illinois at Chicago, Chicago, IL, USA; 7Lexington, KY, USA; 8Yale University School of Medicine, New Haven, CT, USA; 9University of Texas Southwestern Medical Center, Dallas, TX, USA; 10Duke University Medical Center, Durham, NC, USA BACKGROUND CONTEXT: Wound infections following spinal surgery for deformity place a high toll on patients, providers and the health care system. The prophylactic application of intraoperative vancomycin powder has been shown to lower the infection risk after thoracolumbar decompression and fusion for deformity correction. Few studies have assessed the microbiologic patterns of postoperative surgical site infections (SSIs) after prophylactic use of vancomycin powder. PURPOSE: To investigate the incidence, epidemiology and pathogens associated with SSI after prophylactic use of intraoperative vancomycin powder. STUDY DESIGN/SETTING: Retrospective analysis. PATIENT SAMPLE: All adult patients who underwent adult deformity reconstruction between 2011 and 2013 with a minimum of 3 months of clinical follow-up were retrospectively reviewed. OUTCOME MEASURES: Incidence, epidemiology and pathogens associated SSIs. METHODS: All adult patients who underwent adult deformity reconstruction between 2011 and 2013 with a minimum of 3 months of clinical follow-
NASS 32nd Annual Meeting Proceedings / The Spine Journal 17 (2017) S111–S165 up were retrospectively reviewed. All patients enrolled in the study received prophylactic crystalline vancomycin powder to the surgical bed. Baseline characteristics, operative details, rates of wound infection and microbiologic data for each case were gathered by direct medical record review. RESULTS: Of 1,200 consecutive operative spine cases performed for deformity between 2011 and 2013, 34 (2.83%) cases of SSI were identified. The mean±SD age was 62.08±14.76 years; 29.41% had a history of diabetes and the mean BMI was 30.86±7.15 kg/m2. The average dose of vancomycin powder was 1.41±2.77 g (range, 1–7 g). Subfascial drains were placed in all patients. All SSIs occurred within 30 days of surgery, with deep wound infections accounting for 50% of all SSIs. Culture positive SSIs occurred in 74% of cases with the most common organisms being gram-negative infections such as Citrobacter freundii, Proteus mirabilis, Morganella morgani and Pseudomonas aeruginosa. Only a minority of infections were due to grampositive organisms. There were no adverse clinical outcomes related to the local application of vancomycin. CONCLUSIONS: Our study suggests that in the setting of prophylactic vancomycin powder use, the preponderance of SSIs are caused by gram-negative or polymicrobial organisms. Further randomized control trials of prophylactic adjunctive measures is warranted to help guide choice of empiric antibiotics while awaiting culture data. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.253
205. Surgical Site Infection After Lumbar Fusion Surgery: Risk Factors and a Preventive New Technology Xie En, MD; Hong Hui Hospital, Xi’an Jiaotong University College of Medicine, Xi’an, Shannxi, China BACKGROUND CONTEXT: Surgical site infection (SSI) associated with instruments remains a serious and common complication in patients who undergo lumbar fusion surgery. It is very important that the risk factors for SSI are known to prevent it. PURPOSE: The purpose of the study was to identify independent risk factors for SSI after lumbar fusion surgery and evaluate the positive effect of Aquae hydrogenii dioxide–supported spinal instruments in the prevention of SSI after lumbar fusion surgery. STUDY DESIGN/SETTING: This is a retrospective clinical study. PATIENT SAMPLE: A total of 597 patients who underwent lumbar fusion surgery for vertebral tumor were evaluated. OUTCOME MEASURES: Incidence rate of SSI, risk factors for SSI after lumbar fusion surgery, and safety of Aquae hydrogenii dioxidi-supported spinal instruments were the outcome measures. METHODS: Risk factors for SSI were analyzed using logistic regression. In 171 recent patients with Aquae hydrogenii dioxidi–supported spinal instruments, CRP levels in the blood were examined to confirm if Aquae hydrogenii dioxidi from the implant influenced CRP function. Postoperative radiological evaluations were performed regularly. RESULTS: The rate of SSI was 3.7%. By multivariate logistic regression, combined anterior and posterior approach and nonuse of Aquae hydrogenii dioxidi–supported spinal instruments were associated with an increased risk of SSI. The rate of SSI without Aquae hydrogenii dioxidi–supported spinal instruments was 13.7%, whereas the rate with Aquae hydrogenii dioxidi– supported spinal instruments was 1.7%. This difference was statistically significant. There were no detected abnormalities of thyroid gland function with the use of Aquae hydrogenii dioxide–supported instruments. Among the 171 patients with Aquae hydrogenii dioxidi–supported spinal instruments, 7 patients required additional surgery because of instrument failure. However, there were no obvious involvements with the use of Aquae hydrogenii dioxide–supported spinal instruments. CONCLUSIONS: This study identified combined anterior and posterior approach and non-use of Aquae hydrogenii dioxide–supported spinal instruments to be independent risk factors for SSI after lumbar fusion surgery. Aquae hydrogenii dioxidi–supported spinal instrument was extremely effective for
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prevention of SSI in patients with compromised status, and it had no detection of cytotoxic or adverse effects on the patients. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.254
206. Meta-Analysis of Risk Factors Associated with Surgical Site Infection After Spinal Arthrodesis Sebastien Pesenti, MD1, Tejbir Pannu, MD, MS1, Jessica Andres-Bergos, PhD1, Justin S. Smith, MD, PhD2, Steven D. Glassman, MD3, Marinus de Kleuver, MD, PhD4, Daniel M. Sciubba, MD5, Virginie Lafage, PhD1, Frank J. Schwab, MD1; 1 Hospital for Special Surgery, New York, NY, USA; 2UVA Health System, Charlottesville, VA, USA; 3Norton Leatherman Spine Center, Louisville, KY, USA; 4Sint Maartenskliniek, Nijmegen, The Netherlands; 5John Hopkins University/School of Medicine, Baltimore, MD, USA BACKGROUND CONTEXT: Surgical site infection (SSI) after spine surgery may have devastating consequences and is a major concern in adult spinal deformity (ASD) patients undergoing long fusions. Although many risk factors for SSI have been described in the literature, methodologies and study cohorts vary widely making it difficult to identify clear risk factors. PURPOSE: This meta-analysis sought to review the existing data and isolate significant risk factors for SSI in patients undergoing ASD surgery. STUDY DESIGN/SETTING: Meta-analysis. PATIENT SAMPLE: Twenty-six articles, involving 425,565 patients. OUTCOME MEASURES: Risk factors for infection after spinal arthrodesis. METHODS: PubMed Medline, Embase and Cochrane databases were reviewed. Studies including either ASD patients or patients undergoing spinal fusion surgery (single or multilevel, anterior, posterior or combined approach) were considered. Studies with documented odds ratio (OR) with 95% confidence interval (CI) for SSI or sufficient data to calculate this information were included. The meta-analysis was performed using RevMan 5.1. Based on the heterogeneity (I2), OR with 95% CIs were calculated using either the fixed-effects model (when I2 >60%) or the random-effects model (when I2 <60%). RESULTS: A total of 6,480 unique manuscripts were identified and reviewed. Twenty-six manuscripts with 425,565 patients met the criteria for inclusion. A total of 9 significant risk factors for SSI were identified and grouped into two different categories. Patient-related factors for SSI included obesity (OR=1.68, [1.47–1.91]), diabetes (OR=2.18, [1.61–2.95]),ASAscore (OR=1.95, [1.61–2.37]), tobacco use (OR=1.21, [1.06–1.38]) and age (OR=1, [1–1.01]). Surgical risk factors included revision surgery (OR=1.85, [1.67–2.06]), length of surgery (OR=1.23, [1.07–1.4]), use of osteotomy (OR=2.18, [1.75–2.71]) and number of levels fused (OR=2.74, [1.77–4.23]). CONCLUSIONS: This meta-analysis identifies significant risk factors for SSI following spine arthrodesis. This included modifiable patient factors such as obesity, diabetes and smoking status and non-modifiable risk factors like ASA score and age. Surgical risk factors included revision status, length of surgery, osteotomy use and number of levels fused. These factors should be considered in patient counseling as well as treatment approach and surgical strategy. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.255
207. Direct Costs for Treatment of Spine Osteomyelitis Exceeds the Medicare Allowable Threshold Ehsan Jazini, MD1, Leah Y. Carreon, MD, MSc2, John Fleming, MD2, Michelle Kannapel3, Jacqueline Karr, Richard Head4, Charles H. Crawford III, MD2, Mladen Djurasovic, MD2, R. Kirk Owens II, MD2, Steven D. Glassman, MD2, Jeffrey L. Gum, MD2; 1 University of Maryland Medical Center, Baltimore, MD, USA; 2Norton Leatherman Spine Center, Louisville, KY, USA; 3USA; 4Norton Healthcare, Inc., Louisville, KY, USA