Moving SSI Reduction and OR Safety to Scale

Moving SSI Reduction and OR Safety to Scale SSI Evidence a Surgeon s Perspective E. Patchen Dellinger, MD University of Washington

Some things old and Some things new

Caring for the Critically Ill Patient ABC = airway, breathing, circulation

Preventing Surgical Site Infections (SSI) ABC = airway, breathing, circulation = temperature, oxygen, fluids ABCD - Add drugs (antibiotics) Add - glucose control proper hair removal surgical technique teamwork other??

Prophylactic Antibiotics Questions Which cases benefit? Which drug should you use? When should you start? How much should you give? How long should antibiotics be continued?

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 4-12 9-29 Spinal operation 2.2 5.9 27 Total joint repl 0.5-1 2-9 12-100 Brst & hernia ops 3.5 5.2 58

Antibiotic Prophylaxis Demonstrated Benefit: All Procedures?? Review of prophylaxis meta-analyses suggests that there is a consistent relative risk of wound infection less than one associated with antibiotic prophylaxis. This is independent of the type of operation or the baseline (placebo) rate of infection. Bowater. Ann Surg 2009;249: 551 556

Prophylaxis for Clean procedures? Relative reduction of SSI with prophylaxis is the same for all procedures Absolute reduction is less if baseline rate with placebo is less. Decision on whether to use depends on cost of prophylaxis ($, side effects, generating resistance) and the cost of the infection ($, disability, etc).

Prophylactic Antibiotics Questions Which cases benefit? Which drug should you use? When should you start? How much should you give? How long should antibiotics be continued?

Surgical Antibiotic Prophylaxis My Choices Bacteroides expected Cefazolin 2 g + Metronidazole 1g, IV in OR Repeat cefazolin q 3 h during procedure Bacteroides not expected Cefazolin 2 g, IV in OR Repeat q 3 h during procedure

Cefazolin Alternatives Other first generation cephalosporin Cefuroxime, cefamandole, cefonicid Oxacillin, etc Cefazolin plus metronidazole Ertapenem Aminoglycoside or quinolone plus clindamycin or metronidazole

Prophylactic Antibiotics Questions Which cases benefit? Which drug should you use? When should you start? How much should you give? How long should antibiotics be continued?

Decisive Period For Development Of Wound Infection

Efficacy Of Prophylaxis Is Independent Of The Specific Antibiotic

Perioperative Prophylactic Antibiotics Timing of Administration

Prophylactic Antibiotics Timing - Cefazolin Serum Levels (mg/l) On Call Anesth Incision 87 148 1 hour 37 57 2 hours 25 39 DiPiro. Arch Surg 1985;120:829

Prophylactic Antibiotics Timing Cefazolin Muscle Levels Incision Wound closure No Drug Dectectable On Call 9 7 38% Anesth 17 11 14% DiPiro JT et al. Arch Surg. 1985;120:829-832.

Prophylactic Antibiotics Administration in the O.R. Drugs Given I.V. Push over 5-10 Min Cefazolin Drug to incision 17 (7-29) min Muscle levels 76 (9-245) mg/kg Cefoxitin Drug to incision 22 (14-27) min Muscle levels 24 (13-45) mg/kg DiPiro. Arch Surg 1985;120:829 DiPiro. Personal Communication

Timing of Prophylactic Antibiotic Administration Cardiac, Arthroplasty, Hysterectomy Steinberg. TRAPE. Ann Surg 2009; 250:10

Repeat Antibiotic Prophylaxis Doses in Gastrointestinal Procedures Scher. Am Surg 1997;63:59

Prophylactic Antibiotics Questions Which cases benefit? Which drug should you use? When should you start? How much should you give? How long should antibiotics be continued?

Cardiac Surgery Prophylaxis Effect of Serum Levels Serum Level at Wound Closure Infection None Present P =.002 3/11 2/175 Goldmann. J Thorac Cardiovasc Surg. 1977;73:470-479.

Cardiac Surgery Prophylaxis Effect of Atrial Appendage Levels Infected Yes No Cephalothin (mg/l) 6 13 P =.02 Platt. Ann Intern Med. 1984;101:770-774.

Prophylactic Antibiotics Size of Patient and Size of Dose Morbidly obese patients having bariatric operation with a high infection rate Cefazolin levels lower than in non-obese patients at same dose Cefazolin dose changed from 1 g to 2 g Infection rate at 1g: 16.5% Infection rate at 2g: 5.6% Forse RA. Surgery 1989;106:750

Gentamicin Levels and SSI Risk for Colectomy Closing Gent level (mg/l) D.M. (%) Stoma (%) Age SSI 1.3+1.0 29 50 59+14 No SSI 2.1+0.9 2 24 55+19 p 0.02 0.02 0.04 0.05 Gent level < 0.5 at close had 80% SSI rate (p=0.003). Zelenitsky. Antimicrob Ag Chemother 2002;46:3026-30

Dose of Antibiotic for Prophylaxis Always give at least a full therapeutic dose of antibiotic. Consider the upper range of doses for large patients and/or long operations. Repeat doses for long operations.

New ASHP / IDSA / SHEA / SIS Antibiotic Prophylaxis Guidelines Cefazolin < 80 kg 2 g > 120 kg 3 g Vancomycin 15 mg/kg Gentamicin 5 mg/kg dosing wgt = ideal wgt + 40% of excess wgt Bratzler. Am J Health Syst Pharm 2013;70:195-283

Prophylactic Antibiotics Questions Which cases benefit? Which drug should you use? When should you start? How much should you give? How long should antibiotics be continued?

Antibiotic Prophylaxis Duration Most studies have confirmed efficacy of 12 hrs. Many studies have shown efficacy of a single dose. Whenever compared, the shorter course has been as effective as the longer course.

Duration of Prophylaxis Colorectal Author Drug Duration Infection Törnqvist 1981 doxycycline 1 dose 10% 3 days 19% Juul 1987 amp/metronid 1 dose 6% 3 days 6%

Duration of Prophylaxis Joint Replacement Author Drug Duration Infection Pollard 1979 cephaloridine 12 hours 1.4% (hips) flucloxacillin 14 days 1.3% Heydemann 1986 cefazolin 1 dose 0 (hips and knees) 24 hours 1% 48 hours 0 7 days 1.5%

Duration of Prophylaxis: Infection and Antibiotic Resistance Risk in Cardiac Surgery < 48 hr >48 hr Odds Short Long Ratio Number 1502 1139 SSI 131 (8.7%) 100(8.8%) 1.0 (0.8-1.3) Acq Ab Res 6% 1.6 (1.1-2.6) Harbarth. Circulation 2000;101:2916

Single vs Multiple Dose Surgical Prophylaxis: Systematic Review McDonald. Aust NZ J Surg 1998;68:388

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 4-12 9-29 Spinal operation 2.2 5.9 27 Total joint repl 0.5-1 2-9 12-100 Brst & hernia ops 3.5 5.2 58

When I started my residency in 1970 all When I started patients having colectomy got a bowel prep as inpatients before their operation, and we had just seen the first widely believed paper that demonstrated a beneficial effect of parenteral prophylactic antibiotics for patients having GI operations. Oral antibiotics were not used.

Effect of Mechanical Bowel Prep on Colon Flora (log 10 ) Coliforms Bacteroides Clostridia No Prep 4.5 7.5 7.9 9.5 1.8 3.6 Prep 3.0 4.3 7.8 9.0 0.7 2.5 Nichols. Dis Col & Rect 1971; 14: 123-7

Antibiotic and Mechanical Bowel Prep for Colectomy (48 hrs) Any SSI Placebo (63) 27 (43%) Neomycin (68) 28 (41%) Neo + Tetracycline (65) 3 (5%) p<0.01 Washington. Ann Surg 1974;180:567-71

Antibiotic and Mechanical Bowel Prep for Colectomy (18 hrs) Any SSI Placebo (56) 26 (43%) Neo + Erythro (56) 5 (9%) p=0.0001 Clarke. Ann Surg 1977; 186:251-9

Antibiotic and Mechanical Bowel Prep for Colectomy (48 hrs) Any SSI Placebo (59) 25 (42%) Neo + Metronidazole (51) 9 (18%) p<0.01 Matheson. Br J Surg 1978; 65:597-600

Antibiotic and Mechanical Bowel Prep for Colectomy (48 hrs) Any SSI Placebo (39) 16 (41%) Kanamycin + Erythro (38) 3 (8%) p<0.001 Wapnick. Surgery 1979; 85:317-21

Antibiotic and Mechanical Bowel Prep for Colectomy (18-48 hrs) Bowel Prep + Placebo Oral Ab 1974 43% 5% 1977 43% 9% 1978 42% 18% 1979 41% 8%

1980 s Sometime in the 1980 s most American and Canadian surgeons adopted oral antibiotic regimens while most European surgeons abandoned oral antibiotics.

Parenteral Alone vs Parenteral and Oral Antibiotics All with Bowel Prep for Colectomy Lewis. Can J Surg 2002; 45: 173-80

Parenteral Alone vs Parenteral and Oral Antibiotics All with Bowel Prep for Colectomy Meta-Analysis Lewis. Can J Surg 2002; 45: 173-80

MBP yes / no? Antibiotics oral / I.V. / both? Guenaga. Cochrane Database Syst Rev,2009(1):p.C001544 Nelson. Cochrane Database Syst Rev, 2009,(1): p.cd001181

Bowel Preparation Prior to Elective Colectomy in Bowel Preparation Prior to Elective Colectomy in Michigan (n=1648) Overall SSI Rate in Michigan is 8.0% Michigan (n=1648) Overall SSI Rate in Michigan is 8.0%

Surgical Site Infection Rates following Elective Colectomy The Michigan Surgical Quality Collaborative

Oral Antibiotics with a Bowel Preparation A Propensity Matched Analysis (n=740)

Evidence Based Bundle to Prevent SSI in Colorectal Surgery Anthony. Arch Surg 2010; 146: 263-9

Conclusions -? If you are not going to give any oral antibiotics then the MBP is not necessary and there is a suggestion of harm along with more GI symptoms. However, if you are going to take my colon out I will suffer through the bowel prep and take oral antibiotics in advance of the operation for the lowest SSI rate!

Oxygen and SSI

Influence of Oxygen on the Development of Wound Infection Hunt. Am J Med. 1981;70:712.

Wound Oxygen Tension & SSI Hopf. Arch Surg 1997;132:997

Near InfraRed O2 Saturation in the Surgical Incision at 12 hrs Abdominal Operations p < 0.04 Ives. Br J Surg 2007;94:87-91

Oxygen and SSI Oxygen tension in the wound is important. How to translate that into clinical practice that lowers SSI is less obvious.

Temperature and SSI (Oxygen)

Temperature and Tissue O 2 tension Subcut temp increase 4 C Subcut O 2 tension increase 40 torr Linear correlation between temperature and O 2 tension Threefold increase in local perfusion Rabkin. Arch Surg 1987;122:221

Temperature and SSI Following Colectomy Normo (104) Hypo (96) P SSI 6 18.009 Kurz. NEJM 1996;334:1209

Local Warming and SSI after Clean Operations Local Systemic Control SSI* 5 (4%) 8 (6%) 19 (14%) Post-op antibiotics* 9 (7%) 9 (7%) 22 (16%) * p < 0.01 Melling. Lancet 2001;358:876

Perioperative Warming, Intraoperative Temperature and Complications ---- Open Abdominal Bowel Resections Wong. Br J Surgery 2007; 94: 423-6

Redistribution Hypothermia

Hypothermia During Anesthesia 0 ² C ore T em p ( C) -1-2 -3 0 2 4 6 El apsed T i m e (h)

Keeping Your Patient Warm in the O.R. Prewarming and active warming in the O.R. is much more important than the O.R. room temperature. If you raise O.R. room temperature from 20 o to 27 o, you still have an 10 o gradient between the patient s temperature and the room temperature and everyone in the room is miserable.

Prewarming at UWMC & First Postoperative Temperature Post Anesthesia Care Unit (PACU) 2006 > 36 o 7836/8132 (96.4%) > 36 o & < 36.5 o 1047/2647 (40%) > 36.5 o 1491/2647 (56%)

Oxygen (FiO 2 ) and SSI

Spinal Surgery, FiO 2, & SSI Maragakis. Anesthesiol 2009; 110:556-62

Meta-Analysis: FiO 2 & SSI Mayzler Pryor Greif Belda Myles Qadan. O 2 & SSI.Review. Arch Surg 2009; 144:359-66

FiO 2, SSI, Atelectasis, & Respiratory Failure PROXI Trial Meyhoff. JAMA 2009; ;302:1543-50

Glucose and SSI

Diabetes, Glucose Control, and SSIs After Median Sternotomy Latham. ICHE 2001; 22: 607-12

Hyperglycemia and Risk of SSI after Cardiac Operations Hyperglycemia - doubled risk of SSI Hyperglycemic: 48% of diabetics 12% of nondiabetics 30% of all patients 47% of hyperglycemic episodes were in nondiabetics Latham. Inf Contr Hosp Epidemiol. 2001;22:607 Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604

Deep Sternal SSI and Glucose Zerr. Ann Thorac Surg 1997;63:356

Glucose Control and Deep Sternal Wound Infections Furnary et al. Ann Thorac Surg 1999:67:352

Early (48h) Postoperative Glucose Levels and SSI after Vascular Surgery Vriesendorp. Eur J Vasc Endovasc Surg 2004; 28:520-5

Postop Glucose (within 48h) and SSI General Surgery Ata. Arch Surg 2010: 145: 858-864

Rabbit 2 Study Surgery Basal/Bolus vs Sliding Scale Insulin Basal Bolus Sliding Scale p value Patients 104 107 Mean Fasting 155 167 0.04 Mean Daily 157 176.001 Readings < 140 53% 31%.001 Wound infections 3 11.05 Any complication 9 26.003 Umpierrez. Diabetes Care 2011; 34: 256-61

Risk Adjusted Odds Ratios for Infection and Operative Intervention Colectomy and Bariatric Operations Kwon. Ann Surg. 2013; 257: 8-14

Composite Infection in Hyperglycemic Patients With and Without Use of Insulin Kwon. Ann Surg. 2013; 257: 8-14

Glucose in NonDiabetics having Colectomy at Cleveland Clinic Highest Gluc N (%) < 125 mg% 816 (33%) 126-200 mg% 1289 (53%) 200 mg% 342 (14%) All patients 2447 (100%) Kiran, et al. ASA abstract, 2013 meeting

Glucose in NonDiabetics having Colectomy at Cleveland Clinic Highest Gluc SSI* Sepsis Reop Mort + < 125 mg% 2.9% 0.6% 3.1% 0.1% 126-200 mg% 4.8% 2.2% 5% 0.3% 200 mg% 6.1% 3.5% 7.3% 1.2% All patients 4.4% 1.8% 4.7% 0.4% *p<0.03, p<0.01, + p<0.05 Kiran, et al. ASA abstract, 2013 meeting

Glucose in NonDiabetics having Colectomy at Cleveland Clinic

Glucose Levels & SSI The exact best level of glucose control in the perioperative period is not known. High glucose levels unequivocally increase the risk of SSI and other perioperative infections. Tight glucose control in the perioperative period is tricky. Hypoglycemia increases the risk of morbidity and mortality.

Some Things New Teamwork, Communication, and Discipline

BMRI = Behavioral Marker Risk Index Briefing, Information sharing, Inquiry, Vigilance and Awareness

Behavioral Marker Risk Index (BMRI) Induction, Intraoperative, & Handoff (293 cases) Briefing Information sharing Inquiry Vigilance and awareness Adjusted Odds Ratio Risk Factor Complication or Death BMRI 4.82 ASA 1.51 Mazzocco. Amer J Surg 2009; 197: 678-85

Prior to Skin Incision: All Team Members Briefing (Attending Surgeon Leads): Each person introduces self by name and role Surgeon, Anesthesia team and Nurse confirm patient (at least 2 identifiers), site, procedure Personnel exchanges: timing, plan for announcing changes Description of procedure and anticipated difficulties Expected duration of procedure Expected blood loss & blood availability Need for instruments/supplies/iv access beyond those normally used for the procedure Questions/issues from any team member and invitation to speak up at any time in the procedure Nursing/Tech reviews: Equipment issues (instruments ready, trained on, requested implants available, gas tanks full) Sharps management plan Other patient concerns Anesthesia reviews: Airway or other concerns Special meds (beta blockers, etc.) Allergies Conditions affecting recovery

Prior to Skin Incision: Process Control Surgeon reviews (as applicable): Essential imaging displayed; right and left confirmed Antibiotic prophylaxis given in last 60 minutes Active warming in place Special instruments and/or implants If case expected to be 1 hour, add: Surgeon reviews: Glucose checked for diabetics Insulin protocol initiated if needed DVT/PE chemoprophylaxis and/or mechanical prophylaxis plan in place If patient on beta blocker, postop plan formulated Re-dosing plan for antibiotics Specialty-specific checklist

After Skin Closure Complete: No Retained Objects, Debriefing, Care Transition All Team Members (Attending Surgeon Leads): Confirm final needles/sponges/ instruments count correct Nursing/Tech show Surgeon and Anesthesia all sponges and laps in holders ( Show Me Ten ) Confirm name of procedure If specimen, confirm label and instructions (e.g., orientation of specimen, 12 lymph nodes for colon CA) Equipment issues to be addressed? Response planned (who/when) What could have been better? Improvement planned (who/when) Surgeon and Anesthesia: Key concerns for patient recovery What is the plan for pain mgmt? What is the plan for prevention of PONV? Does patient need special monitoring (time in RR, ICU, tele?) If patient has elevated blood glucose, plan for insulin drip formulated If patient on beta blocker, post-op continuation plan formulated

Checklist and Complications Before After n=3773 n=3955 SSI 6.2% 3.4% Unplan Return-O.R. 2.4% 1.8% Any Complic 11.0% 7.0% Death 1.5% 0.8% Haynes. NEJM 2009; 360: 491-9

Checklist and Complications Before After n=3760 n=3820 SSI 3.8% 2.7% Complic/100 pts 27.3 16.7 Pts with Complic 15.4% 10.6% Death 1.5% 0.8% de Vries. NEJM 2010; 363: 1928-37

Checklist Completion and Complications Checklist Completion Complic Above median 7.1% Below median 11.7% de Vries. NEJM 2010; 363: 1928-37

Checklist Completion and Mortality Adjusted Odds Ratio Mortality All patients 0.85 (0.73-0.98) van Klei. Ann Surg 2012; 255: 44-9

Checklist Completion and Mortality Adjusted Odds Ratio Mortality All patients 0.85 (0.73-0.98) Completed 0.44 (0.28-0.70) Partial 1.09 (0.78-1.52) Not done 1.16 (0.86-1.56 van Klei. Ann Surg 2012; 255: 44-9

JAMA 2010; 304:1693-1700

Team Training and Mortality Neily. JAMA 2010; 304:1693-1700

Team Training and Morbidity 42 VA hospitals underwent team training and 32 did not during 2007. Both groups demonstrated reduction in overall morbidity and postoperative infections from 2006 to 2008. Hospitals with team training had 20% greater reduction in morbidity (p<0.001) and 17% greater reduction in infections (p<0.005). Young-Xu. Arch Surg 2011;146:1368-73.

What to do about Staph??

Nasal Colonization and S. aureus SSI Colony Percent of Infection Count N Carriers Rate 0 345 -- 8% < 10 3 14 13% 7% > 10 3 92 87% 21% White. AAC 1963; 161: 667-70

Nasal Colonization and S. aureus SSI Ortho Implants Nares Infection Culture N Rate Neg 199 3 (1.5%) Pos 73 (27%) 6 (8%) - Heavy 63% - Light 37% Multivariate analysis only heavy colonization was significantly associated with Staph infection (p=0.002) Kalmeijer. ICHE 2000; 21: 319-23

Mupirocin vs Control to Prevent S. aureus Nosocomial Infections in Carriers 0.55 [ 0.43, 0.70 ] Van Rijen. Cochrane Review, 2009, Issue 1

Effectiveness of Eradication in S. aureus Positive Patients 5 Hospitals 6771 patients screened 1270 (18.8%) positive for S. aureus 917 randomized to eradication or no eradication Bode. NEJM 2010; 362: 9-17

Effectiveness of Eradication in S. aureus Positive Patients Mupirocin ointment applied to nares twice daily for 5 days Chlorhexidine gluconate soap (Hibiclens) used on entire body once daily for 5 days Bode. NEJM 2010; 362: 9-17

Effectiveness of Eradication in S. aureus Positive Patients Mup/CHG Cont RR Number 504 413 (95% Conf Int) Any S aureus infect 17 (3.4%) 32 (7.7%) 0.42 (0.23-0.75) Surgical patients 441 367 Deep SSI 4 (0.9%) 16 (4.4%) 0.21 (0.07-0.62) Superficial SSI 7 (1.6%) 13 (3.5%) 0.45 (0.18-1.11) Any SSI 11 (2.5%) 29 (7.95) 0.32 (0.16-0.62) NOT ADDRESSED: How long before surgery to start. What to do with patients who require operation immediately. Bode. NEJM 2010; 362: 9-17

Effectiveness of Eradication in S. aureus Positive Patients 90% of the surgical patients were admitted the day before operation and received one or two decolonization treatments prior to the operation. Decolonization treatments were then continued for a duration of five days. Most of the remaining 10% of patients were operated at some later time. Kluytmans. Personal Communication. Sept 2011

Effectiveness of Eradication in S. aureus Positive Patients Number needed to screen to prevent one S. aureus infection = 250 Number of carriers needed to treat to prevent one S. aureus infection = 23 Bode. NEJM 2010; 362: 9-17

Vancomycin vs Cefazolin Prophylaxis in a Cardiac Surgery Unit with High Prevalence of MRSA Cefaz (433) Vanco (452) SSI, any 39 (9.0%) 43 (9.5%) SSI 2º to MSSA 5 10 SSI 2º to MRSA 7 2 SSI 2º to Gram neg rods 20 21 BSI, any 18 20 BSI 2º to MSSA 2 6 BSI 2º to MRSA 4 2 Finkelstein. J Thorac Cardiovasc Surg 2002;123:326

Vancomycin vs B-lactam Prophylaxis in Cardiac Surgery and Arthroplasty 22,549 Procedures in Victoria, Australia Adjusted Odds Ratio for any SSI Variable OR 95% CI P Proc. Duration, min 1.003 1.002-1.004 <0.001 ASA score > 3 1.71 1.42-2.07 <0.001 Vancomycin proph 1.40 1.02-1.93 0.04 Bull. Ann Surg 2012; 256: 1089-92

Vancomycin vs B-lactam Prophylaxis in Cardiac Surgery and Arthroplasty 22,549 Procedures in Victoria, Australia Adjusted Odds Ratio for SSI with MSSA Variable OR 95% CI P Proc. Duration, min 1.003 1.002-1.004 <0.001 ASA score > 3 1.89 1.30-2.74 <0.001 Vancomycin proph 2.79 1.60-4.87 <0.001 Bull. Ann Surg 2012; 256: 1089-92

New Prophylaxis Guidelines from ASHP/SIS/IDSA/SHEA For patients at risk for MRSA infection use: Vancomycin and Cefazolin Bratzler. Am J Health Syst Pharm 2013;70:195-283

Nasal Mupirocin vs. Povidone Iodine, both with CHG in Spine and Arthroplasty Patients Deep SSI Mupirocin (n=761) 5 (0.7%) Pov Iod (n=776) 0 p=0.05 PreOp S.A. colonization associated with S.A. SSI (p=0.002) Phillips. ID Week 2012. Abstract LB3

Not Discussed Due to Time but probably or possibly(?) important Sterile technique Wound protectors? Impregnated sutures? Prevention of nonsurgical infections Management of the incision after operation?

Preventing SSI Have good teamwork at all times Prewarm the patient Enough of the right antibiotic at the right time and repeat if necessary Don t shave Thorough skin prep including alcohol Warm the patient in the O.R. High FiO 2 Control glucose Good teamwork & debrief

Slide Set and References available by request patch@uw.edu