Surgical Site Infection Prevention The Cardiovascular Surgical Translational Study (“CSTS”) Armstrong Institute for Patient Safety and Quality Elizabeth Martinez, MD, MHS martinez.elizabeth@mgh.harvard.edu

Armstrong Institute for Patient Safety and Quality Learning Objectives To understand the evidence based practices for SSI reduction To understand the model for translating evidence into practice To explore how to implement evidence-based behaviors to prevent SSI To understand strategies to engage, educate, execute and evaluate 9/21/2011 Armstrong Institute for Patient Safety and Quality

Proportion of Adverse Events Most Frequent Categories Non-surgical Surgical Brennan. N Engl J Med. 1991;324:370-376 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Introduction Over 300,000 CABG annually SSI rates 3.51% (10,500 annually) 25% mediastinitis 33% saphenous vein site 6.8% multiple sites Increased mortality:17.3% v. 3.0% (p<0.0001) Increased LOS: 47% v 5.9% with LOS>14days (p<0.0001) Increased cost: $20,000 to $60,000 Fowler et al.Circ, 2005:112(S), 358. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality CABG SSI Risk Model* Preop Age Obesity Diabetes Cardiogenic shock Hemodialysis Immunosuppression Intraop Perfusion time Placement of IABP ≥ 3 anastomoses *Did not include known best practices (e.g. SCIP) Fowler et al.Circ, 2005:112(S), 358. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Traditional SSI Risk Factors Intrinsic-Patient Related Age Nutritional status Diabetes Smoking Obesity Remote infections Endogenous mucosal microorganisms Altered immune system Preoperative stay-severity of illness Wound class 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Preventive Measures* Appropriate hair removal Appropriate prophylactic antibiotic use Selection, timing, redosing**, discontinuation Perioperative normothermia Perioperative normoglycemia *Surgical Care Improvement Metrics **Proposed SCIP measure 1/16/2019 Armstrong Institute for Patient Safety and Quality

CDC Guidelines for Antibiotic Prophylaxis 1. The procedure should carry a significant risk of infection and/or cause significant bacterial contamination. There are 3 SCIP measures for the appropriate use of prophylactic antibiotics. These are: Prophylactic abx received within 1 hour prior to incision, Appropriate abx selection, Discontinuation of abx within 24 hours after surgery end time. The Guidelines to evaluate and follow when implementing a local, evidence-based practice for these choices include that (1) –The procedure should carry a significant risk of infection and/or cause significant bacterial contamination. For example, there are no evidence based guidelines to suggest that prophylactic abx are indicated for tonsillectomy or urethral dilatation if the urine is sterile. However – most of the teams involved today are following procedures in which prophylactic abx are indicated. Mangram. Infect.Control Hosp.Epidemiol. 1999;20(4):250 1/16/2019 Armstrong Institute for Patient Safety and Quality

Relative Benefit from Antibiotic Surgical Prophylaxis Operation Prophylaxis (%) Placebo (%) NNT* Colon 4-12 24-48 3-5 Other (mixed) GI 4-6 15-29 4-9 Vascular 1-4 7-17 10-17 Cardiac 3-9 44-49 2-3 Hysterectomy 1-16 18-38 3-6 Craniotomy 0.5-3 9-29 Total joint 0.5-1 2-9 12-100 Breast & hernia ops 3.5 5.2 58 This is a summary slide – showing the difference in the infection rate for various procedures and the number needed to receive the appropriate abx at the appropriative time to prevent on SSI. The differences in the NNT reflect the degree of risk of contamination. The number needed to treat (NNT) is an epidemiological measure used in assessing the effectiveness of a health-care intervention, typically a treatment with medication. The NNT is the number of patients who need to be treated in order to prevent one additional bad outcome (i.e. to reduce the expected number of cases of a defined endpoint by one). It is defined as the inverse of the absolute risk reduction * Number Needed to Treat 1/16/2019 Armstrong Institute for Patient Safety and Quality

CDC Guidelines for Antibiotic Prophylaxis 2. The antibiotic selected must be active against the major contaminating organisms and should have previously been shown to be effective prophylaxis. It is NOT necessary to cover ALL organisms present. The next principle to keep in mind as local Guidelines are utilized is that The antibiotic selected must be active against the major contaminating organisms and should have previously been shown to be effective prophylaxis. 1/16/2019 Armstrong Institute for Patient Safety and Quality

WOUND INFECTION: ORGANISMS 1990-1996 Staphylococci and Streptococci are the most common organisms of concern for most procedures, whereas anaerobes and Enterobacteriaceae are common for GI cases. Many published guidelines for AMP [5,6,11-15] are available for development of local antibiotic guidelines; local sensitivity profiles also should be taken into account. 1/16/2019 Armstrong Institute for Patient Safety and Quality

CDC Guidelines for Antibiotic Prophylaxis 3. The antibiotic chosen must achieve concentrations higher than the minimal inhibitory concentration (MIC) of the suspected pathogens in the wound site at the time of incision. Unpublished data with cefazolin is adequate for average MIC within 3 minutes – Consideration must be made when a tourniquet is used – that the abx is administered prior to tourniquet inflation. Also – while there are mixed data on whether the infusion, of say vanc or clindaymicin needs to be completed prior to incision – most experts would advocate completion to make certain there are adequate levels. Of course – the goal should be avoidance of these except only with true pcn allergies – which is essentially in those patient with hives of previous anaphylaxis with exposure to a penicillin. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Give antibiotics within 60 minutes prior to incision. Relative Risk Antibiotic levels of the individual agents must be higher than the MIC at the time of incision Individual agents must be considered Cefazolin has a Vd of 10-12 L can can be pushed within minutes of incision Additional doses dependent on half-life and blood loss We have clinical data. Classen et al reported findings on 2847 patients investigating the timing of prophylactic antibiotics and surgical wound infections. In this study of patients undergoing clean or clean-contaminated surgery were prospectively monitored for antibiotic timing and incidence of SSI. This slide summarizes the results of that study showing that if antibiotics were not given in the preop time period defined as 0-120 minutes – the relative risk of infection ranged from 2.4 x baseline if given after incision, and 5.8 to 6.7 times the risk if given too early or postoperatively. Classen. NEJM. 1992;328:281. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Cardiac surgery prophylaxis effect of serum levels Serum Level at Wound Closure Infection None Present 3/11 (27%) 2/175 (1%) Observational studies have shown that repeated intraoperative dosing of an antibiotic with a short half-life is associated with a decreased risk of SSI. P = .002 Goldmann. J Thorac Cardiovasc Surg. 1977;73:470-479. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Cefazolin Half-life 1/16/2019 Armstrong Institute for Patient Safety and Quality

CDC Guidelines for Antibiotic Prophylaxis 4. The shortest possible course of the most effective least toxic antibiotic must be used for prophylaxis. Must consider distribution and half-life of individual agents. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Does prolonged peri-op abx prophylaxis have consequences? Prospective surveillance 2641 patients undergoing cardiac surgery Exposure outcome: cephalosporin resistant enterobacteriaceae and VRE Prolonged antibiotic prophylaxis (>48 h) increase the risk of acquired resistance (OR 1.6, CI 1.1-2.6) 1/16/2019 Armstrong Institute for Patient Safety and Quality

CDC Guidelines for Antibiotic Prophylaxis 5. The newer broader spectrum agents must be saved for therapy of resistant organisms and should not be used for prophylaxis. 1/16/2019 Armstrong Institute for Patient Safety and Quality

Antimicrobial Prophylaxis: Category IB Evidence Do not routinely use vancomycin for antimicrobial prophylaxis IT IS NOT THE BEST AGENT FOR SKIN FLORA! If Vancomycin is used “it is recommended that an aminoglycoside be considered for one preoperative and at most one additional postoperative dose to act as a specific gram-negative agent when vancomycin is indicated to be the primary prophylactic agent.”1 This may not be commonly used but should be considered if you have a problem with gram negative infections. 1Ann Thorac Surg 2007;83:1569–76 1/16/2019 Armstrong Institute for Patient Safety and Quality

Hyperglycemia and Infection Risk: Abdominal and Cardiovascular Operations Glucose POD#1 <220 mg% >220 mg% Any Infection 12% 31% “Serious” Infection 5.7-fold increase for any glucose > 220 mg% Glycemic control in the perioperative care of surgery is beginning to gain momentum. The predominance of the data are in cardiac and critical care patients. There are also compelling animal and lab data to support the impact of normoglycemia on infection and wound healing. Pomposelli et all followed 100 diabetic patients undergoing abdominal and CV surgery and showed the glycemic control early in the postop course decreased patients risk. Pomposelli. JPEN 1998;22:77 1/16/2019 Armstrong Institute for Patient Safety and Quality

Portland Diabetes Project: Mortality CII 10 8 6 4 Mortality (%) 87 88 89 90 91 92 93 94 98 99 00 Year Patients with diabetes Patients without diabetes 2 95 96 97 01 Portland Diabetic Project: Mortality All patients with diabetes undergoing CABG (N = 3,554) were treated aggressively with either subcutaneous insulin (1987–1991) or continuous insulin infusion (1992–2001) for hyperglycemia in this nonrandomized, prospective study. Observed mortality and glucose control were both significantly better with continuous insulin infusion than with subcutaneous insulin therapy. Continuous insulin infusion independently reduced perioperative absolute mortality by 57% and risk-adjusted mortality by 50%. Improved survival was attributed to a reduction in cardiac-related deaths. Furnary AP, Gao G, Grunkemeier GL, et al. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003;125:1007–1021. Eliminating the diabetic disadvantage. Furnary AP, et al. J Thorac Cardiovasc Surg. 2003;125 1/16/2019 Armstrong Institute for Patient Safety and Quality

ADDITIONAL CONSIDERATIONS FOR REDUCING SSI 1/16/2019 Armstrong Institute for Patient Safety and Quality

Chlorhexidine is Beneficial as Surgical Skin Prep Br J Surg. 2010 Nov;97(11):1614-20 1/16/2019 Armstrong Institute for Patient Safety and Quality

Selective Nasal Decolonization Bode. N Engl J Med 2010;362:9-17 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Nasal Decolonization Selective decolonization Rapid PCR Patients with S. aureus Protocol used Mupirocin PLUS chlorhexidine baths The duration of the study treatment was 5 days, irrespective of the timing of any interventions. Patients who were still hospitalized after 3 weeks and those still hospitalized after 6 weeks received a second and third course of the same trial medication, respectively. Bode. N Engl J Med 2010;362:9-17 1/16/2019 Armstrong Institute for Patient Safety and Quality

Mupirocin Recommendations STS recommendations “beginning at least the day before operation (sooner, if elective operation) and continuing for 2 to 5 days after surgery.” 1 CSTS recommendations Selective decolonization 1Ann Thorac Surg 2007;83:1569–76 1/16/2019 Armstrong Institute for Patient Safety and Quality

Preoperative Chlorhexidine Baths Mixed data Do demonstrate decrease in skin colony count Little data including cardiac surgical patients Consider as part of a comprehensive program 1/16/2019 Armstrong Institute for Patient Safety and Quality

Estimated Overall Benefits1 Process Relative Risk Reduction NNT* Clipping vs. Shaving 70% 21 Normothermia 68% 8 Appropriate Abx timing 80% 42 Glycemic control* 63% 31 *Number Needed to Treat **Post op cardiac and Abd 1/16/2019 Armstrong Institute for Patient Safety and Quality

Summary Recommendations First line antibiotic Cefazolin 2 grams to be given within 60 minutes prior to incision Cefazolin to be redosed within 4 hours Consider 2-3 hours Perioperative antibiotics to be discontinued prior to 48 hours Use a clipper to remove hair; remove the least area as possible Maintain glucoses in the 140-180 range and prevent hyperglycemia >200mg/dL Chlorhexidine for skin prep Selective decolonization 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Learning Objectives To understand the evidence based practices for SSI reduction To understand the model for translating evidence into practice To explore how to implement evidence-based behaviors to prevent SSI To understand strategies to engage, educate, execute and evaluate 1/16/2019 Armstrong Institute for Patient Safety and Quality

Translating Evidence into Practice Pronovost, Berenholtz, Needham. BMJ 2008 1/16/2019 Armstrong Institute for Patient Safety and Quality

Your Hospitals’ Performance* *summarized (estimate) data for all surgical procedures from all participating Institutions as of 3/31/2011 www.hospitalcompare.hhs.gov; Accessed 3/5/2011 1/16/2019 Armstrong Institute for Patient Safety and Quality

Ensure Patients Reliably Receive Evidence   Senior Team Staff leaders Engage How does this make the world a better place? Educate What do we need to do? Execute What keeps me from doing it? How can we do it with my resources and culture? Evaluate How do we know we improved safety? 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Engage Make the problem real Share local infection rates Share local compliance with process measures Share a story of a patient with SSI Have the patient share their story Publicly commit that harm is untenable Institutional commitment Champions within the OR and the ICU and floor teams Partnership with Infection Preventionist 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Educate Develop an educational plan to reach ALL members of the caregiver team Educate on the evidence based practices AND the data collection plan and other steps of the process. Use multiple methods to educate Posters to educate the teams about the evidence-based process measure Presentations at staff/faculty meetings, M&M 1/16/2019 Armstrong Institute for Patient Safety and Quality

Six Steps to Prevent SSI 1. Avoid Razors 2. Avoid Hypothermia >36 degrees 3. Give Correct Antibiotics 4. Give Antibiotics at the Right Time *Within 60 minutes prior to incision 5. Redose Antibiotics Appropriately 6. Antibiotics at 24 Hours 1/16/2019

Perioperative SSI Process Measures Quality Indicator Numerator Denominator Appropriate antibiotic choice Number of patients who received the appropriate prophylactic antibiotic All patients for whom prophylactic antibiotics are indicated Appropriate timing of prophylactic antibiotics Number of patients who received the prophylactic antibiotic within 60 minutes prior to incision Appropriate discontinuation of antibiotics Number of patients who received prophylactic antibiotics and had them discontinued in 24 hours All patients who received prophylactic antibiotics Appropriate hair removal Number of patients who did not have hair removed or who had hair removed with clippers All surgical patients Perioperative normothermia Number of patients with postoperative temperature ≥36.0oC Patients undergoing surgery without CPB/planned hypothermia Perioperative glycemic control Number of cardiac surgery patients with glucose control at 6AM pod 1 and 2 Patients undergoing cardiac surgery 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Execute Culture Develop a culture of intolerance for infection Standardize/Reduce complexity of the process Checklists -Confirm abx administration during briefing Utilize a glycemic control protocol Local antibiotic guidelines posted in ORs Standardize surgical skin prep Redundancy Add best practices to briefing/debriefing checklist Post reminders in the OR (White board) Antibiotic timer program for redosing Regular team meetings Develop a project plan Identify barriers 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Evaluate Track compliance with SCIP measures Performance measures already being tracked by hospitals as part of SCIP participation* Post performance on monthly basis Post in the OR, ICU and floor Investigate non-compliant cases on a monthly basis Use Learning from Defect (LFD) tool Post SSI rates on a monthly/quarterly basis Investigate each SSI with the CUSP team to identify areas for improvement using the LFD tool Audit performance with skin prep methodology (at a minimum) and goal is conversion to chlorhexidine There are data from all participating hospitals on hospital compare and SCIP is very highly penetrated nationally so we do not anticipate additional data collection burden for the evidence-based practices (SCIP infection measures). Check with your hospital QI/QA leaders to confirm tracking of these measures for cardiac surgery and brainstorm how to present these data these data locally. The goal is leverage current data collection burden for the teams. *based on data availability on Hospital compare 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Share Results 1/16/2019 Armstrong Institute for Patient Safety and Quality

Armstrong Institute for Patient Safety and Quality Acknowledgements Deborah Hobson, BSN Pamela Lipsett, MD Sara Cosgrove, MD Lisa Maragakis, MD Trish Perl, MD Matthew Huddle, BS Nicole Errett, BS Justin Henneman, BS Joyce Wahr, MD The Johns Hopkins SSI Prevention Collaborative teams 1/16/2019 Armstrong Institute for Patient Safety and Quality

QUESTIONS? Thank you! Elizabeth Martinez, MD, MHS Massachusetts General Hospital, Harvard Medical School martinez.elizabeth@mgh.harvard.edu