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Flow Pharma Edura Gentamicin Microsphere Technology Under Development for Surgcal Site Infection Prevention

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  • 1. Instrumented SpineSurgical Site Infections (SSI) source: AAOS orthopaedic knowledge online

2. Contents Risk Factors for SSI Economic impact of SSIs SSI Isolates Presentation of SSI Current methods of prophylaxis Novel approaches for prophylaxis The Edura gentamicin advantage 3. Risk FactorsAmy Cizket al. Bone and Joint, 2012.Retrospective analysis of 1532 pts over 1 yearInclusion: > 18yo, no prior SSI, invasiveness index > 0Not statistically significant: age group (p = 0.16 0.60); smoking (p = 0.83); PVD (p = 0.17) 4. Risk FactorsAmy Cizket al. Bone and Joint, 2012.Retrospective analysis of 1532 pts over 1 yearInclusion: > 18yo, no prior SSI, invasiveness index > 0 5. Risk Factors Summary Primary Impact Factor on SSIs:Surgical invasiveness Secondary Impact Factors on SSIs:Treating pre-existing diseaseNot operating on high risk patients 6. Economic Impact About 300,000 US spine fusion surgeries/year1 SSI rate about 6% overall2 Cost per SSI about $24,0002 Total annual spine fusion SSI cost = 0.06 X 300,000 X $24,000 = $432,000,000 Spine fusion SSI now an HAC for IPPS hospitals CMS bulletin May 2012 The hospitals pay 7. Analysis of SSI isolates Pullter Gunne et al. Spine, 2010. Retrospective cohort analysis of 3174 pts over 9 years Culture yields Isolated organisms* Diagnosed SSI: 132 (4.2%) Gram(+): 82 (68%) Deep component: 84 (64%) Gram(-): 27 (22%) Superficial only:_____________________________________________________________________________________________________________________________ _____________________________ 48 (36%)_____________________________________________________________________________________________________________________________ _____________________________ S. aureus: 63 (76%) Culture (+): 83 (63%) MSSA:54 (86%) MRSA:9 (14%) Culture (-): 38 (29%)_____________________________________________________________________________________________________________________________ _____________________________ E. faecalis: 12 (14%) Monomicrobial: 63 (77%) E. coli9 (11%) Polymicrobial: 20 (24%) K. pneumoniae6 (7%)* Percentages calculated as a function of the number of patients with culture growth 8. Analysis of SSI isolates Pullter Gunne et al. Spine, 2010. Retrospective cohort analysis of 3174 pts over 9 years Culture yields Isolated organisms* Diagnosed SSI: 132 (4.2%) Gram(+): 82 (68%) Deep component: 84 (64%) Gram(-): 27 (22%) Superficial only:_____________________________________________________________________________________________________________________________ _____________________________ 48 (36%)_____________________________________________________________________________________________________________________________ _____________________________ S. aureus: 63 (76%) Culture (+): 83 (63%) MSSA:54 (86%) MRSA:9 (14%) Culture (-): 38 (29%)_____________________________________________________________________________________________________________________________ _____________________________ E. faecalis: 12 (14%) Monomicrobial: 63 (77%) E. coli9 (11%) Polymicrobial: 20 (24%) K. pneumoniae6 (7%)* Percentages calculated as a function of the number of patients with culture growth 9. Presentation of SSI Pullter Gunne et al. Spine, 2010. Retrospective cohort analysis of 3174 pts over 9 yearsMedian Time to Diagnosis (d) Signs & Symptoms Deep SSI: 15 (6 - 730) ESR 94.4% Superficial SSI:18 (5 - 85) CRP 98.0% WBC 44 - 58% Microbial trends _____________________________________________________________________________________________________________________________ _____________________________ Drainage 88 (67%) Gram(-) isolates 4X as frequentPain 36 (27%)in deep vs superficial SSI Fever34 (26%) Erythema 24 (18%) 10. Current methods of prophylaxis IV 1st gen cephalosporin IV vanco non-superior3 Discectomy< 1% Antiseptic prep Decompression 1.5 2% Chlorahex / betadine /isopropanolFusion1 5% Ioban dressing Instrumentation 3 9% Laminar flow systems Trauma8 13% Agency for Healthcare Research and Quality, 2004 Limited room traffic 11. Current methods of prophylaxis The economic impact of SSI is large Big spine surgeries are high risk for SSI Current methods are not effective The hospitals are paying for SSI care 12. Novel methods for SSIprophylaxisIntrawound Application of Vancomycin PowderSweet et al. Spine, Nov. 2011.Retrospective cohort study of 1732 consecutive pts over 11 years 13. Vancomycin Powder Sweet et al. Objective: To examine safety, drug levels, efficacy Inclusion: Thoracic / lumbar posterior instrumented fusions Control: 2g IV Ancef: 2000 2006, (n = 821) Tx: 2g vancomycin powder adjunct: 2006 2011, (n = 911) Average follow-up: 2.5 years (1 7 year range) 14. Vancomycin Powder Sweet et al.Results drug levels Local drug levels, POD 0 3 (n = 178, consecutive) Post op day0 123 Drug level (g/mL) 1457 (263-2938) 462 (97-2258) 271 (48-732) 128 (37-311) Serum drug levels: Day 1: 20% detection, average level 1.6 g/mL (range 0.7 5.9) Days 2 3: 6% detection, serum levels not reported ISDA guideline: Keep trough above 10 g/mL to avoid resistance 4 S. aureus in vitro MIC commonly ranges from