Online Evaluation, Self-Assessment and CE/CME Credit

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1 December 10, 2018 Update on the Prevention of Surgical Site Infections Faculty Speaker: Tom Talbot, MD, MPH, FSHEA, FIDSA Professor of Medicine and Health Policy, Vanderbilt University School of Medicine Chief Hospital Epidemiologist Vanderbilt University Medical Center Online Evaluation, Self-Assessment and CE/CME Credit Pharmacists, Physicians: Post test & evaluation are required for CE/CME credit Go to Print your CE/CME statement of completion online Credit for live or enduring (not both) Deadline: January 11, 2019 Pharmacists: complete the claim credit step for CE upload to CPE Monitor Attendance Code Nurses: Evaluation is required for Nurse CE credit Go to Must have registered for and used your registration link to watch the webinar. Deadline: December 21, 2018 Questions: Alexis Schrieber, Pharm.D. at Code will be provided at the end of today s activity 2 1

2 How to Ask a Question Locate menu bar on your computer desktop Click orange arrow button to open menu box Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No! Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Click hyperlink 4 2

3 CE/CME Activity Information & Accreditation (Pharmacist CE) This CE activity is jointly provided by and CHSPSC, LLC. ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number L01 P has been assigned to this knowledge based live CE activity (initial release date ). This CE activity is approved for 1.0 contact hours (0.1 CEU) in states that recognize ACPE providers. This CE activity is provided at no cost to participants. Successful completion of the online post test and evaluation at is required to receive CE credit. CE credit will be uploaded to NABP/CPE Monitor. No partial credit will be given. Ultimate Medical Academy (Physician CME) This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Ultimate Medical Academy (UMA), ProCE, and Community Health Systems (CHS). Ultimate Medical Academy (UMA) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians Ultimate Medical Academy (UMA) designates this live activity for a maximum of 1.0 AMA PRA Category 1 credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity. CHSPSC, LLC. (Nurse CE) The nursing CE is accredited by CHS. CHS is an approved provider of continuing nursing education by the Alabama State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. Funding: This activity is self funded through CHSPSC, LLC. 5 December 10, 2018 Update on the Prevention of Surgical Site Infections Faculty Speaker: Tom Talbot, MD, MPH, FSHEA, FIDSA Professor of Medicine and Health Policy, Vanderbilt University School of Medicine Chief Hospital Epidemiologist Vanderbilt University Medical Center It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Talbot does not have any relevant commercial and/or financial relationships to disclose. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature

4 DISCLAIMERS I am not a surgeon I do not believe that SSIs and lapses in practices are necessarily intentional/of malicious intent 7 Background: SSI >30 million surgeries/year in US #1 (tie) healthcare associated infection Expanding issues: Novel techniques Move to outpatient arena Immunosuppressed pts 8 4

5 Surgical Site Infections Major source of surgical infections = the patient s own flora If the bacterial burden, esp. at the site of the incision, can be reduced reduce risk of SSI 9 Public Reporting of SSI Rates Risk adjustment limited?consistency with application of SSI definitions Tied to payments SSI added to Centers for Medicaid and Medicare payment system for acute care hospitals Colon surgery Abd hysterectomy Services

6 Magill SS et al New Engl J Med 2018;379: Risk Factors for SSI Patient Factors: Diabetes Periop hyperglycemia Tobacco use (current) Malnutrition Prolonged pre op stay? Age Irradiation? Corticosteroid use Obesity Operative Factors: Surgical technique Poor skin prep Incorrect abx prophylaxis Use of razor Shaving night before Break aseptic technique No pre op antiseptic shower Prolonged procedure

7 New SSI Prevention Guidelines Allegranzi B et al Lancet Infect Dis 2016;16:e276+ Allegranzi B et al Lancet Infect Dis 2016;16:e288+ Berrios Torres SI et al JAMA Surg 2017;152: Surgical Antibiotic Prophylaxis

8 Who Needs Surgical Antimicrobial Prophylaxis? Recommended for all clean contaminated procedures e.g. colon, small bowel, gyn Recommended for clean procedures: a) involving insertion of intravascular prosthetic material or a prosthetic joint or b) in which an SSI would pose catastrophic risk (e.g. cardiac surgery) Contaminated/dirty procedures: Assume already on abx Should also ensure Staphylococcal coverage 15 Bowater RJ et al Ann Surg 2009;249:

9 Key Principles of Surgical Prophylaxis Tissue concentration of antimicrobial needs to be above the mean inhibitory concentration (MIC) of that drug for the organisms of concern AT THE TIME OF THE INCISION Get the D s right: Right Drug Right Dose Right Delivery (i.e. timing) Right Duration 17 Abx Given Antibiotic Concentration in Relation to Incision Concentration TOO LOW Abx Concentration in Tissue Concentration OK MIC for likely encountered organisms Incision Incision Incision Incision

10 RIGHT DELIVERY: Relation of Abx Timing to Risk for Developing SSI Time of Administration # Pts No (%) of SSI OR (95% CI) 6 >2 hrs before incision (3.8%) 4.3 ( ) 0 2 hrs before incision (0.6%) hrs after incision (1.4%) 2.1 ( ) 3 24 hrs after incision (3.3%) 5.8 ( ) 5 Infection Rate (%) > >10 Hours Before Incision Incision Hours After Incision Classen DC et al NEJM 1992;326: RIGHT DELIVERY: Relation of Abx Timing to Risk for Developing SSI Steinberg JP et al Arch Surg 2009;250:

11 Timing of Abx Prophylaxis: Still in Question? 2013 Multispecialty Guideline Give within 60 mins unless glycopeptide or quinolone 2016 WHO SSI Guideline Given within 120 mins 2017 HICPAC SSI Guideline 21 Koch CG et al J Thorac Cardiovasc Surg 2012;144:

12 Spectrum of activity RIGHT DRUG: Basic Principles Cover the pathogens of concern at anatomic location Bioactivity/penetration into target tissues Limited toxicity Patient allergies Cost(if all other factors equal)

13 Antibiotic Allergy and SSI Prophylaxis Retrospective cohort Hip/knee arthroplasty, hyst, colon, CABG pts Blumenthal KG et al Clin Infect Dis 2018;66: What About MRSA Coverage? Use of vancomycin recommended if outbreak situation or if local incidence levels are high Many communities do not know local incidence of MRSA (infection or colonization) Literature limited by use of non standard dosing (e.g., 1gm Q 12 hrs instead of weightbased dosing)

14 Meta analysis Studies Study Population Sample Size Comparisons Results Bolon et al Cardiothoracic pts 7 RCTs lactams vs. glycopeptides SSI 30 days post op RR 1.14 (95% CI ) Chambers et al Clean & cleancontaminated procedures 14 RCTs lactams vs. glycopeptides Similar effectiveness for SSI prevention Saleh et al Cardiac, vascular, and orthopedic surgical pts 14 RCTs lactams vs. glycopeptides No difference in SSIs; Glycopep signif reduced Staph SSI by 48% but increased resp tract infections by 54%; Cardiac: lactam signif reduced SSIs Bolon MK et al Clin Infect Dis 2004;38:1357+ Chambers D et al Surg Infections 2010;11:455+ Saleh A et al Ann Surgery 2015;261: Vancomycin for Surgical Prophylaxis What is the level of MRSA prevalence where vancomycin has benefit? STS: Use if known h/o MRSA colonization, undergoing prosthetic valve/graft placement, or healthcare exposures (hosp > 3 days, inpt transfer, on abx) Use of MRSA bundle Screen for carriage Decolonization with mupirocin Nares and at chest tube sites Add vancomycin for MRSA + pts (continue cefazolin)

15 Abx Choice: Guideline Recommendations 2017 HICPAC SSI Guideline No comment on abx choice 2016 WHO SSI Guideline No comment on abx choice 2013 Multispecialty Guideline 29 RIGHT DOSE: Gastroplasty Patients and Cefazolin Levels Cefazolin (mg/ml)? 3 gms? Forse RA et al Surgery 1989;106:

16 What About Another Dose? Tissue concentrations fall during procedure redose of Abx may be needed, but need to redose before tissues levels drop below MIC Operative Procedure Time Abx Given Abx Given Incision Vulnerable Period (Incision open, tissue abx levels low) 31 Kasatpibal N et al Surg Infections 2017;18:

17 RIGHT DURATION: How Long Should Abx be Continued? Desire to protect tubes and drains May increase risk of infection with MDRO Study in cardiac surgery patients No difference in infection rate in those w/abx 48 hrs vs. < 48 hrs Significantly risk for infection w/ resistant organisms (by 60%) w/ prolonged abx Harbarth S et al Circulation 2000;101: RIGHT DURATION: Single vs. Multiple Doses Favors single dose Favors multiple doses No benefit of multiple doses over single perioperative dose McDonald M et al Aust N Z J Surg 1998;68:

18 Abx Duration: Guideline Recommendations 2017 HICPAC SSI Guideline 2016 WHO SSI Guideline 35 How Well Do Did We Do? Timing of First Dose of Abx Bratzler DW et al Arch Surg 2005;140:

19 How Well Do Did We Do? Duration of Surgical Prophylaxis Bratzler DW et al Arch Surg 2005;140: Quality Measures for Surgical Care: SCIP 1: Abx within 1hr (2hr if vancomycin used) SCIP 2: Selection of abx SCIP 3: Timely discontinuation of Abx (24hrs, except for cardiac surgery = 48hrs)

20 S INF Core = INF 1, INF 2, INF 3 S INF = 2 or more of Any INF measure Stulberg et al JAMA 2010;303: Have the SCIP Metrics Slipped? SCIP abx prophylaxis measure reporting retired Jan 2015 With lack of transparency, focus on other quality measures has compliance faltered?

21 Reasons for Failure of Surgical Antimicrobial Prophylaxis Patient risk factors Procedural risk factors Hair removal with razor Inappropriate skin antisepsis Hypothermia during procedure Incorrect dosing/drug/delivery Antibiotic resistant pathogens When to change standard agents? 41 Staph. aureus Colonization as a Risk for Infection RCT of mupirocin in general, gynecologic, neurosurgical, and CT procedures OR of S. aureus SSI in colonized vs. non colonized placebo recipients = 4.5 ( ) Cardiac surgery patients: Carriers 9.6 times more likely to have SSI than noncolonized patients Harvest site infections: RR of S. aureus SSI in colonized vs. non colonized patients = 7.1 ( ) Perl TM et al NEJM 2002;346:1871+ Kluytmans JA et al L Infect Dis 1995;171:

22 RCTs of Mupirocin Decolonization Nosocomial S. aureus infections among surgical pts with SA carriage S. aureus SSIs among surgical pts with SA carriage van Rijen MM et al J Antimicrob Chemother 2008;61: RCT in Netherlands Adult patients admitted to departments of surgery and internal medicine screened for SA carriage (PCR) Carriers randomized to mupirocin CHG decolonization vs. placebo soap & ointment Mupirocin: BID for 5 days CHG: Daily for 5 days Reapplication at 3 weeks and 6 weeks if still hospitalized Bode LGM et al NEJM 2010;362:

23 N = 6771 screened 1251 SA+ (18.5%) 918 randomized Placebo group with signif. more immunocompromised pts. No data on compliance w/ other SSI prevention measures Bode LGM et al NEJM 2010;362:9+ 45 Assessed bundle to reduce S. aureus SSIs 20 hospitals in 9 states Cardiac, hip arthroplasty, knee arthroplasty Bundle: If SA nasal screen +: Intranasal mupirocin BID and daily CHG bathing x 5 days pre op Added vancomycin if MRSA + carrier Schweitzer ML et al JAMA 2015;313:

24 RR 0.58 (95% CI ) Schweitzer ML et al JAMA 2015;313: Screening + Decolonization Benefits: It s cheap (maybe) It s easy (usually) It works (in some pts) Risks: Increased infections due to other pathogens? Resistance development Questions: Does effect last? Use in all populations? Costs of screening? Which screening test? Impact of mupirocin resistance

25 RCT adults undergoing clean contaminated GI/GU/GYN/Thoracic surgery at 6 sites Chlorhexidine alcohol vs. povidone iodine Outcome: Any SSI within 30 days N = 849 Overall SSI Rate: P I group: 16.1% CHG alcohol group: 9.5% RR: 0.59 (95% CI: ) Darouiche RO et al NEJM 2010;362: NNT to prevent 1 SSI = 17 Darouiche RO et al NEJM 2010;362:

26 Impact noted with superficial and deep SSI, NOT organ space SSI The weight of evidence suggests that chlorhexidine alcohol should replace povidone iodine as the standard for preoperative surgical scrubs. Common criticism: No comparison with povidone + alcohol was benefit due to combination with alcohol?? Darouiche RO et al NEJM 2010;362:18+ Wenzel RP NEJM 2010;362: Surgical Skin Antisepsis CHG based prep appears to be best Avoid use with: < 2 month old Mucous membranes Contact with meninges**

27 CHG Pre Operative Bathing Reductions in skin bacterial colonization in some studies Significant SSI reductions not noted in many studies Different methods and preparations used? Removed immediately after application? Use of agents that inactivate CHG 53 Chlebicki MP et al Am J Infect Control 2013;41:

28 Skin Prep: Guideline Recommendations 2017 HICPAC SSI Guideline 2016 WHO SSI Guideline 55 Hypoxia & SSI: Pathophysiology WBC bactericidal activity secondary to oxidative killing Use of superoxide radicals Dependent upon partial pressure of O 2 in tissue Disruption of local vascular supply O 2 Provision of higher FiO2 reduced SSI?

29 Randomized Trials of High and Low Inspired FiO 2 and SSI Study Intervention Sample Size Grief et al (2000) FiO 2 30% vs. FiO 2 80% Patient Population 250 per arm Elective colorectal SSI Rates* 30% arm: 11.2% 80% arm: 5.2% Comments Trial stopped early Pryor et al (2004) FiO 2 35% vs. FiO 2 80% 80 per arm Elective major abdominal 30% arm: 11.3% 80% arm: 25% Trial stopped early Belda et al (2005) FiO 2 30% vs. FiO 2 80% 143 in 30%; 148 in 80% Elective colorectal 30% arm: 24.4% 80% arm: 14.9% Mayzler et al (2005) FiO 2 30% vs. FiO 2 80% (both w/n 2 O) 19 per arm Elective colorectal 30% arm: 17.6% 80% arm: 12.5% Nonsignificant Myles et al (2007) FiO 2 30% + N 2 O vs. FiO 2 80% + nitrogen 977 in arm 1; 1015 in arm 2 Elective or emergent noncardiothoracic resection 30% arm: 10.0% 80% arm: 7.7% Differing comparators (N 2 O vs. N) *Variable SSI definitions Grief R et al NEJM 2000;342:161+ Pryor KO et al JAMA 2004;291:79+ Belda FJ et al JAMA 2005;294:2035+ Mayzler O et al Minerva Anestesiol 2005;71:21+ Myles PS et al Anesthesiology 2007;107: Randomized Trials of High and Low Inspired FiO 2 and SSI Study Intervention Sample Size Grief et al (2000) FiO 2 30% vs. FiO 2 80% Patient Population 250 per arm Elective colorectal SSI Rates* 30% arm: 11.2% 80% arm: 5.2% Comments Trial stopped early Pryor et al (2004) FiO 2 35% vs. FiO 2 80% 80 per arm Elective major abdominal 30% arm: 11.3% 80% arm: 25% Trial stopped early Belda et al (2005) FiO 2 30% vs. FiO 2 80% 143 in 30%; 148 in 80% Elective colorectal 30% arm: 24.4% 80% arm: 14.9% Mayzler et al (2005) FiO 2 30% vs. FiO 2 80% (both w/n 2 O) 19 per arm Elective colorectal 30% arm: 17.6% 80% arm: 12.5% Nonsignificant Myles et al (2007) FiO 2 30% + N 2 O vs. FiO 2 80% + nitrogen 977 in arm 1; 1015 in arm 2 Elective or emergent noncardiothoracic resection 30% arm: 10.0% 80% arm: 7.7% Differing comparators (N 2 O vs. N) *Variable SSI definitions Grief R et al NEJM 2000;342:161+ Pryor KO et al JAMA 2004;291:79+ Belda FJ et al JAMA 2005;294:2035+ Mayzler O et al Minerva Anestesiol 2005;71:21+ Myles PS et al Anesthesiology 2007;107:

30 Randomized Trials of High and Low Inspired FiO 2 and SSI Study Intervention Sample Size Grief et al (2000) FiO 2 30% vs. FiO 2 80% Patient Population 250 per arm Elective colorectal SSI Rates* 30% arm: 11.2% 80% arm: 5.2% Comments Trial stopped early Pryor et al (2004) FiO 2 35% vs. FiO 2 80% 80 per arm Elective major abdominal 30% arm: 11.3% 80% arm: 25% Trial stopped early Belda et al (2005) FiO 2 30% vs. FiO 2 80% 143 in 30%; 148 in 80% Elective colorectal 30% arm: 24.4% 80% arm: 14.9% Mayzler et al (2005) FiO 2 30% vs. FiO 2 80% (both w/n 2 O) 19 per arm Elective colorectal 30% arm: 17.6% 80% arm: 12.5% Nonsignificant Myles et al (2007) FiO 2 30% + N 2 O vs. FiO 2 80% + nitrogen 977 in arm 1; 1015 in arm 2 Elective or emergent noncardiothoracic resection 30% arm: 10.0% 80% arm: 7.7% Differing comparators (N 2 O vs. N) *Variable SSI definitions Grief R et al NEJM 2000;342:161+ Pryor KO et al JAMA 2004;291:79+ Belda FJ et al JAMA 2005;294:2035+ Mayzler O et al Minerva Anestesiol 2005;71:21+ Myles PS et al Anesthesiology 2007;107: Overall RR High FiO2 = 0.74 (95% CI ) Qadan M et al Arch Surg 2009;144:

31 The Scoop on O 2 and SSI Benefits: It s cheap It s easy It worked in several RCTs Risks:? atelectasis Pulmonary toxicity? Not seen in RCT Associated with increased risk in RCT Questions: Variable SSI ascertainment Use in noncolorectal pts? Manner of delivery important? Nasal cannula vs. mask 61 Periop O 2 : Guideline Recommendations 2017 HICPAC SSI Guideline 2016 WHO SSI Guideline

32 SSI & Perioperative Glucose Control 6% of subjects not known to have diabetes (42/700) had Hgb A1c 7.0% Diabetes = 2.7 fold increase in SSI risk HgbA1c not associated with increased risk Odds Ratio fo SSI Under Postoperative Glucose Level (mg/dl) Latham R et al ICHE 2001;22: Glucose Control: Guideline Recommendations 2017 HICPAC SSI Guideline 2016 WHO SSI Guideline

33 Periop Forced Air Warming & SSI competitor scott augustineadmits role in manufacturing lawsuits against bair hugger device 65 Normothermia: Guideline Recommendations 2017 HICPAC SSI Guideline 2016 WHO SSI Guideline

34 Causes of SSI: Impaired Providers? Sherertz RJ et al Infect Control Hosp Epidemiol 2009;30: Hübner M et al Arch Surg 2011;146:

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36 Higher patient complaints associated with higher surgical complications Adjusted for patient factors (age, sex, race/ethnicity, BMI, functional status, ASA class, ventilator dependence, history of severe COPD/CHF/DM/HTN/preoperative renal failure/disseminated cancer at the time of the operation), operative characteristics (surgeon specialty, # of cases contributed to the study cohort by the surgeon, case urgency, wound classification, long operative time), and deidentified study site Cooper WO et al JAMA Surg 2017;152: Fan CJ et al J Amer Coll Surg 2016;222:

37 The Challenge Create a culture where speaking up is the norm Encourage vigilance for all members of the team Move from Show me why I should do it to Show me why you should not Standardize practices 73 New Challenges for SSI Care Changes in surgical arena Move to outpatient/office venues New surgical techniques Minimally invasive procedures Optimizing surveillance Impact of devices? Worldwide Mycobacterium chimaera outbreak related to heater cooler devices