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A Mechanistic and Evidence-Based Approach to Reducing the Surgical Site Infections

A Mechanistic and Evidence-Based Approach to Reducing the Surgical Site Infections. Charles E. Edmiston Jr., PhD., CIC Professor of Surgery & Hospital Epidemiologist - Department of Surgery Medical College of Wisconsin Milwaukee, Wisconsin USA edmiston@mcw.edu.

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A Mechanistic and Evidence-Based Approach to Reducing the Surgical Site Infections

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  1. A Mechanistic and Evidence-Based Approach to Reducing the Surgical Site Infections Charles E. Edmiston Jr., PhD., CIC Professor of Surgery & Hospital Epidemiologist - Department of Surgery Medical College of Wisconsin Milwaukee, Wisconsin USA edmiston@mcw.edu

  2. 2010 National Patient Safety Goals (NPGS) – The Joint Commission Health Care-Associated Infections • NPSG.07.03.01: Implement evidence-based practices to prevent health care-associated infections due to multidrug-resistant organisms in acute care organizations (critical access facilities). • NPSG.07.04.01: Implement evidence-based practices to prevent central line-associated bloodstream infections (critical access and long-term care facilities). • NPSG.07.05.01: Implement evidence-based practices for preventing surgical site infections (critical care, ambulatory and office-based surgical facilities).

  3. “Risk Reduction Requires an Understanding of the Mechanistic Factors which Potentiate the Risk of Infection in the Surgical Patient Population”

  4. Maki DG, Hospital Infections (3rd ed) 1992 p. 861

  5. Evidence-Based Hierarchy

  6. Goal of the Surgical Care Improvement Project (SCIP) Reduce preventable surgical morbidity and mortality by 25% by the year 2010

  7. Mitigating Risk - Surgical Care Improvement Project (SCIP) – An Evidence-Based Approach • Timely and appropriate antimicrobial prophylaxis • Glycemic control in cardiac and vascular surgery • Appropriate hair removal • Normothermia in general surgical patients Is this the Holy Grail?

  8. An Increase in Compliance With the Surgical Care Improvement Project Measures Does Not Prevent Surgical Site Infection in Colorectal Surgery Pastor et al. Diseases of the Colon & Rectum 2010; 53:24-30

  9. “The report by Stulberg et al in this issue of JAMA is the largest study to date that fails to demonstrate an association between adherence to SCIP process measures and the occurrence of postoperative infections. The authors found no significant association between individual process measures or the all-or-none composite core measurement composed of all 3 measures for prophylactic antibiotic administration and postoperative infection. They report a modest association between adherence to a composite measure that included at least 2 of the 6 SCIP measures applied to an expanded SCIP population and postoperative infection. Despite substantial improvements in SCIP adherence over the 2-year study period, postoperative infection rates actually increased.” MT Hawn – Editorial JAMA

  10. Does the Process Improve the Outcome? The author’s analysis suggest that, “…there was little or no association between compliance with most SCIP infection-related process measures and ACS NSQIP risk-adjusted outcome…….with the exception of administration of the appropriate antibiotic (SCIP-2).” • Ingraham et al. J Am Coll Surg 2010;211:705-711

  11. Taking a SCIP-Plus Perspective to Risk Reduction

  12. Does BMI Increase Risk?

  13. Perioperative Antimicrobial Prophylaxis in Higher BMI (>30) Patients: Do We Achieve Therapeutic Levels? Percent Therapeutic Activity of Serum/Tissue Concentrations Compared to Surgical Isolate Susceptibility (2002-2004/2006-2009) to Cefazolin Following 2 gm (N = 38) and 3 gm (N = 40) Perioperative Dosing Regimen 2-gma 3-gmb Organism N Serum Tissue N Serum Tissue S. aureus 70 68.6% 27.1% 92 87.5% 68.5% S. epidermidis110 34.5% 10.9% 156 64.5% 49.6% E. coli 85 75.3% 56.4% 101 92.4% 86.5% Kl. pneumoniae 55 80%65.4% 49 96.8% 98.4% a period covering 2001-2003 b period covering 2006-2009 aEdmiston et al, Surgery 2004;136:738-747 bEdmiston et al., In Press 2011: Surgical Infection

  14. Effect of Maternal Obesity on Tissue Concentration Of Prophylactic Cefazolin During Cesarean Delivery Pevzner L, Edmiston CE, et al. Obstet & Gynecol 2011;117:877-882

  15. Perioperative Cefazolin Prophylaxis During Cardiovascular Surgery: Are Therapeutic Levels Impacted by BMI?* Percent (%) N = 10/Group *% therapeutic level versus BMI and cefazolin breakpoint Surgical Microbiology Research Laboratory 2010

  16. Best Practice # 1: All surgical patients will receive a minimum dose of 2 gram unless their BMI is >30 – Then the correct dose is 3 grams • Please Note: All surgical procedures at Froedtert Hospital are viewed as SCIP-eligible procedures

  17. Risk Reduction Begins on the Front End

  18. Microbial Ecology of Skin Surface • Scalp 6.0 Log10cfu/cm2 • Axilla 5.5 Log10cfu/cm2 • Abdomen 4.3 Log10cfu/cm2 • Forearm 4.0 Log10cfu/cm2 • Hands 4.0-6.6 Log10cfu/cm2 • Perineum 7.0-11.0 Log10cfu/cm2 Surgical Microbiology Research Laboratory 2008 – Medical College of Wisconsin

  19. Mean Chlorhexidine Gluconate (CHG) Skin Surface Concentrations (µg/ml+SD) Compared to MIC90(5 µg/ml) for Staphylococcal Surgical Isolates Including MRSAa Subgroups (mean C, µg/ml) Pilotb 1 2 Groups (4%) (4% Aqueous) (2% Cloths) [CCHG/MIC90] p-value Group A (20) evening (1X) 3.7+2.5 24.4+5.9 436.1+91.2 0.9 4.8 87.2 <0.001 Group B (20) morning (1X) 7.8+5.6 79.2+26.5 991.3+58.2 1.9 15.8 198.2 <0.0001 Group C (20) both (2X) 9.9+7.1 126.4+19.4 1745.5+204.3 2.5 25.3 349.1 <0.0001 a N = 90 Edmiston et al, J Am Coll Surg 2008;207:233-239 Edmiston et al, AORNJ 2010;92:509-518 b Pilot group N = 30

  20. Why CHG Showering/Cleansing Makes Sense?

  21. Presurgical Skin Preparations as a Pathwayto Improving Patient Outcomes (Evidence-Based) • Reducing the risk of SSI in orthopaedic surgery • Standardized precleansing initiative (CHG cloths) in total joint patients (night before/morning of surgery) • 50% overall reduction in SSI Eiselt - Orthopaedic Nursing 2009;28:141-145 • Bundling risk reduction strategies – Quality initiative • MRSA prescreening in orthopaedic, obstetric, bariatric patients – decolonization + precleansing with 2% CHG • >60% overall reduction in SSI • >75% reduction in MRSA SSI Lipke VL Hyott AS. AORNJ 2010’;62:288-296 • Eradication of MRSA in orthopaedic patients • 60% reduction in MRSA infections • 40% reduction in MSSA infection • Kim et al. J Bone Joint Surg 2010;92;1820-1826

  22. Institutional Prescreening for Detection and Eradication of Methicillin Resistant Staphylococcus aureus in Patients Undergoing Elective Orthopaedic Surgery Kim DH, Spencer M, Davidson SM, et al. J Bone Joint Surg Am 2010;92:1820-1826

  23. Institutional Prescreening for Detection and Eradication of Methicillin Resistant Staphylococcus aureus in Patients Undergoing Elective Orthopaedic Surgery Kim DH, Spencer M, Davidson SM, et al. J Bone Joint Surg Am 2010;92:1820-1826

  24. Best Practice # 2: All patients undergoing an elective surgical procedure will take a minimum of 2 CHG antiseptic shower/cleansings using a standardized regimen – The CHG must be supplied to the patient by the hospital

  25. Why CHG – Why not!

  26. Why Should We Consider Chlorhexidine Gluconate (CHG)? • Persistent antimicrobial activity for up to 6 hours 1, 5 • Documented residual activity and repeat applications will maximize antimicrobial effect 2, 5 • Rapid bactericidal action 3, 5 • Has good to excellent activity against gram-positive and gram-negative bacteria 4, 5 • CHG activity is not adversely impacted by either blood or tissue proteins 5 1. Larson E, APIC guidelines for infection control practice: guideline for use of topical antimicrobial agents. Am J Infect Control. 1988;16(6):253-65; 2. Paulson D, Am J Infect Control. 1993;21:205-9; 3. Denton GW, Chlorhexidine. In Seymour S. Block (Ed.) Disinfection, sterilization, and preservation. 4th Ed., Lea & Febiger, Williams & Wilkins, Media PA, 1991:279; 4. Mangram AJ, et al., Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital Infection Control Practices Advisory Committee, Atlanta GA.; 5. Edmiston CE et al. Am J Infection Control 2007;35:89.

  27. DESIGN: A PROSPECTIVE, RANDOMIZED, MULTICENTER CLINICAL TRIAL OF 2% CHLORHEXIDINE GLUCONATE / 70% ISOPROPYL ALCOHOL (Alc-CHG) VS POVIDONE- IODINE (PI) FOR PREVENTION OF SSI Multi Center:Michael E. Debakey Veterans Affairs Medical Center, Ben Taub General Hospital, Houston, Veterans Affairs Medical Center, Boston, Medical College of Wisconsin, Milwaukee, Veterans Affairs Medical Center, Atlanta, Baylor College of Medicine, Houston • Patients > 18 years, undergoing clean-contaminated procedures (gastrointestinal, thoracic, urologic and gynecologic) • N = 849 surgical patients: 409 Alc-CHG vs 440 PI • 1:1 randomization • Patients monitored for 30 days post-op • Overall rate of SSI was significantly reduced in Alc-CHG vs PI groups: 9.5% vs 16.1%, p=0.004 • Significant difference for both superficial incisional site rate: 4.2% A-CHG vs 8.6% PI (p=0.008) and deep incisional: 1% A-CHG vs 3% PI (p=0.05) • No significant adverse events noted during the study in either group • Alc-CHG superior to PI in reducing the risk of SSI in clean-contaminated procedures New England Journal of Medicine 2010;362:18-26

  28. Best Practice # 3: Alcohol/chlorhexidine gluconate represents the state-of-the-art skin antiseptic agent • Please Note: Froedtert services using Alcohol/CHG for skin antisepsis: general, vascular, CT, orthopaedic, urology, neurosurgery, OB/GYN, hepatobiliary, solid organ transplant

  29. Utilizing Innovative Impregnated Technology to Reduce the Risk of Surgical Site Infections J Am CollSurg 2006;203:481-489

  30. Are Sutures Really a Nidus for Infection? Staphylococcus epidermidis Incisional Wound Infection Surgical Microbiology Research Laboratory, Milwaukee - 2005

  31. Mean Microbial Recovery from Standard Polyglactin 910 Sutures (V) and Triclosan-Coated Polyglactin 910 Braided Sutures (VT) V VT N=10 Mean colony forming units (cfu)/cm suture p<0.01 102 105 102 105 102 105 S. aureus(MRSA) S. epidermidis RP62A E. coli Exposure Time 2 Minutes Edmiston et al, J Am Coll Surg 2006;203:481-489

  32. Making an Evidence-Based Argument for Antimicrobial (Triclosan) Coated Sutures Safety 1. Ford et al. Intraoperative handling and wound healing…… Surg Infect 2005;3:313 Clinical Efficacy 2. Edmiston et al. Bacterial adherence to surgical sutures:…Surgery 2006;203:481. 3. Rozzelle at al. Antimicrobial sutures for wound closure in CSF shunt surgery…… J Neurosurg 2008;42:111 4. Pico et al. Incisional closure following appendectomy in children….Pediatric Surg 2008;21:199 5. Justinger et al. Antimicrobial coating of abdominal closure sutures and infection….. Surgery 2009;145:330 6. Mingmalairak et al. Efficacy of antimicrobial coated sutures in reducing SSI following appendectomy. J Med Assoc Thai 2009;92:770 7. Chao-ping et al. Comparison of two absorbable sutures for abdominal wall closure. J Clin Rehab Tissue Eng Research 2009;13:4045 8. Galal et al. Impact of using triclosan-antibacterial sutures on incidence of surgical site infection. Am J Surgery 2011 (In Press) Economic Benefit 9. Fleck et al. Triclosan-coated sutures for reduction of sternal wound infection….Ann Thor Surg 2007;84:232 10. Stone et al. Healthcare saving associated with reduced infection in CSF shunt procedures….Pediatric Neurosurg 2009;46:19-24

  33. Best Practice # 4: A myriad of evidence-based studies support the adoption of an antimicrobial closure technology – However, this should never be viewed as a “magic bullet” but part of a thoughtful, integrated, evidence-based process

  34. A Special Consideration: Device-Related Breast Infections

  35. Considering the Risk and Microbial Epidemiology of Breast Infections: Non-Device versus Device-Related • Operative closure and SSI in women undergoing breast conserving therapy (N=580) -11.7% (superficial) vs. 5.2% (full-thickness) • Indelicato et al, Surgery 2007;141:645 • Economic burden N=949): mastectomy with immediate reconstruction (implant) – 12.4% vs. mastectomy only – 4.4% vs. breast reduction – 1.1% - Suboptimal antimicrobial prophylaxis modifiable risk factor • Olsen et al, J Am CollSurg 2008;207:326 • Breast augmentation (N=3,002) – 1.1% (<1.0%-2.5%): modifiable risk factor – drains • Araco et al, Aesthetic Plastic Surgery 2007;31:325

  36. Considering the Risk and Microbial Epidemiology of Breast Infections • Microbial Etiology Percent • Methicillin-sensitive Staphylococcus aureus 41.9 (35)a • Methicillin-resistant Staphylococcus aureus16.3 (22) • Coagulase-negative staphylococci 7.0 (11) • Streptococcal sp. 4.7 (<2.0) • Gram-negative 8.0 (<6.0) • Pseudomonas aeruginosa18.6 (<7.0) • Polymicrobial 16.3 (<12) • No growth 9.3 (<6.0) • aMCW implant experience (2000-2009) • Olsen et al, J Am Coll Surgery 2008;207:326 “Is cefazolin sufficient in breast implant surgery“ – Feldman et al, PlastReconstrSurg 2010;126:779

  37. Staphylococcal Biofilm - Surgical Microbiology Research Laboratory 2006 - Medical College of Wisconsin

  38. Thoughtful Approach to Risk Reduction in Breast Reconstruction • CHG shower or cleansing • Augment antibiotic dosing – 2 to 3 grams • Antimicrobial (CHG) dressing post JP insertion • CHG irrigation (0.05%) Improving Patient Outcome Requires Commitment & Innovation

  39. Expanding the Mechanistic Possibilities

  40. Looking at the Risk of Surgical Site Infections from a New Mechanistic PerspectiveSurgical Glove Perforation and the Risk of Surgical Site Infection – Analysis of 4147 Surgical Cases • Compared to a control group logistic regression model documented a higher likelihood of SSI in procedures in which surgical gloves were perforated and errors had occurred in antimicrobial prophylaxis (adjusted OR, 4.2; 95% CI, 1.7-10.8; P=0.003). Misteli et al. Arch Surgery 2009;144:553-558 Bacteria Passage Following Surgical Glove Perforation • Over a 4 month interval the microperforation rate of the outer layer ranged from • 4.7% to 28% - allowing bacterial passage across the surgical glove into the • surgical wound. Harmob et al. Am J Infect Control 2010;38:154-158

  41. Integrated Antimicrobial Surgical Glove Technology Outermechanical layer Middle layer including the antimicrobial liquid in drop- like compartments Innermechanical layer Skin (hand) Sonntag et al., Nature Materials 2004;3:311-315 Krikorian R, J Hosp Infect 2007;66:339-345

  42. Mean Microbial (S. aureus) Recovery (cfu/ml) at 10 and 45 Minutes Post Surgical Glove Microperforation* 418 351 cfu/ml 292 p<0.005 NS 24.5 180 p<0.005 p<0.05 1.4 *N = 24 gloves per group Daeschlein and Edmiston – Am J Infect Control 2011;39:98-103

  43. Why Should an Antimicrobial Surgical Glove be Viewed as a Risk Reduction Strategy Viewing Risk from a Mechanistic Perspective • Microperforation rates exceed 25% in selective surgical services • Microbial rebound (hand) occurs in all surgical cases • Perforation rates highest in non-dominant hand (thumb and index finger) • Wound bed vulnerable to contamination – hyperglycemia and corticosteroids diminish wound defenses • Biomedical devices at high risk for contamination – 40% of SSI discovered beyond 30 days

  44. Caveat - Surgical site infections represent a complex and multi-factorial process - the mechanistic etiology is quite often elusive, requiring innovative solutions

  45. Era of Surgical Transparency – NHSN and CMS (308d Participation and Consent Document)

  46. A New Era of Transparency – A Surgeon’s Perspective • 4-year colorectal infection rate = 24.5% (Surgery 2007;142:704) • Operative closure and SSI in women undergoing breast conserving therapy = 5.2 to 11.7% (Surgery 2007;141:645) • SSI risk factors in inflammatory bowel patients undergoing colorectal procedures = >15% (Diseases Colon & Rectum 2007;50:331) • Post-cesarean surgical site infection rate – 8.9% (post-discharge) vs 1.8% at hospital discharge (ActaObstetGynecol 2007;86:1097) Thinking outside of the box – impact of BMI, diminished granulocytic cell function

  47. The Pogo Effect – “Yep, we have met the enemy and he is us”

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