Reducing The Risk ofSurgical Site Infections:

Improving PatientsOutcomes Using an

Evidence-Based Approach

Charles E. Edmiston Jr., PhD., CICProfessor of Surgery & Hospital Epidemiologist -

Department of Surgery Medical College of WisconsinMilwaukee, Wisconsin USA

edmiston@mcw.edu

Froedtert Hospital Infection Control Team2013 – 2014

Chairman, Infection ControlCommittee

Mary Beth Graham, MD,

Infection Control CoordinatorsPatti Wilson, BSN, CICPat Sadenwasser, BSN, CICMary Jane Dorava, BSN, CNOR

MicrobiologistsNathan Ledeboer, PhD, D-ABMMCandy Krepel, MS, SM-ASCP

Hospital EpidemiologistCharles Edmiston, PhD, CIC

Administrative SupportDonna Welter, CMSM

Learning ObjectivesLearning Objectives

• Discuss the economic impact and risk-factorsassociated with SSIs

• List the four SCIP core measures and theircurrent impact on reducing the risk of SSIs

• Briefly discuss 5 evidence-based best practicesthat can improve clinical outcomes in thesurgical patient population

• Describe how one builds an evidence-basedintervention – Intraoperative irrigation with0.05% CHG

Relative Economic and Social BurdenAssociated With the Most Common HAIs

Relative Economic and Social BurdenAssociated With the Most Common HAIs

SSI

CLABSI

VAP

CAUTI

Est. Annual No.of Infections

Direct Cost perPatient (2007$) Excess Stay Mortality

>290,485

92,011

52,543

449,334

>$34,670

$29,156

$28,508

$1,007

7->10 days

4-20 days

4-13 days

1-3 days

3 - >5

4- >20%

10-70%

1%

http://www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf

Infection

“Risk Reduction Requires anUnderstanding of the Mechanistic Factorswhich Potentiate the Risk of Infection in

the Surgical Patient Population”

A More Than a Typical Scenario – What isthe True Risk of Infection?

A More Than a Typical Scenario – What isthe True Risk of Infection?

High Risk Patient:Immunosuppressive meds - RA

DiabetesAdvanced agePrior surgery to same jointPsoriasisMalnourished

morbid obesitysAlb<35low sTransferrin

Remote sites of infectionSmokersASA ≥3

Recalibrating the Myth - ThatInfections are a Rare Event

Recalibrating the Myth - ThatInfections are a Rare Event

National Nosocomial Infections Surveillance (NNIS) System report, data summary from January 1992 throughJune 2004, issued October 2004. Am J Infect Control. 2004;32(8):470-485. WHO guidelines for safe surgery

2009. http://whqlibdoc.who.int/publications/2009/9789241598552_eng.pdf. Accessed February 22, 2011

SSI rates by Operative Procedure inPatients with Multiple Risk factors

Approximately 1-1.5 million SSIs

occur annually inthe US

A New Era of Transparency – A Surgeon’sPerspective

• 4-year colorectal infection rate = 24.5%(Surgery 2007;142:704)

• Operative closure and SSI in womenundergoing breast conserving therapy = 5.2to 11.7% (Surgery 2007;141:645)

• SSI risk factors in inflammatory bowelpatients undergoing colorectal procedures =>15% (Diseases Colon & Rectum2007;50:331)

• Post-cesarean surgical site infection rate –8.9% (post-discharge) vs 1.8% at hospitaldischarge (Acta Obstet Gynecol2007;86:1097)

Thinking outside of the box – impact of BMI, diminishedgranulocytic cell function

Evidence-Based Hierarchy

Mitigating Risk - SurgicalCare Improvement Project

(SCIP) – An Evidence-BasedApproach

Mitigating Risk - SurgicalCare Improvement Project

(SCIP) – An Evidence-BasedApproach

• Timely and appropriateantimicrobial prophylaxis

• Glycemic control in cardiacand vascular surgery

• Appropriate hair removal

• Normothermia in generalsurgical patients

Is this the Holy Grail?

An Increase in Compliance With the Surgical CareImprovement Project Measures Does Not Prevent Surgical

Site Infection in Colorectal Surgery

Pastor et al. Diseases of the Colon & Rectum 2010; 53:24-30

Evidence-Based Adjunctive RiskReduction Strategies

Does BMI Increase Risk?

Somewhere in Wisconsin - Patient’s Weight vs.

Dose (N= 520 - pre-SCIP)Somewhere in Wisconsin - Patient’s Weight vs.

Dose (N= 520 - pre-SCIP)

14.9%

85.1%

52%48%

<70kg (n=63/130)

>70kg (n=67/130)

>70kg (dose not adjusted n=57/67)

>70kg (dose adjusted n=10/67)

Does BMI Increase Risk?

Percent Therapeutic Activity of Serum / Tissue Concentrations Compared

to Surgical Isolate (2002-2004) Susceptibility to Cefazolin Following 2-gm

Perioperative Dose

Organisms n Serum Tissues

Staphylococcus aureus 70 68.6% 27.1%

Staphylococcus epidermidis 110 34.5% 10.9%

E. coli 85 75.3% 56.4%

Klebsiella pneumoniae 55 80% 65.4%

Edmiston et al, Surgery 2004;136:738-747

Perioperative Antimicrobial Prophylaxis in Higher BMI(>40) Patients: Do We Achieve Therapeutic Levels?

Does BMI Increase Risk?

Effect of Maternal Obesity on Tissue ConcentrationOf Prophylactic Cefazolin During Cesarean Delivery

Pevzner L, Edmiston CE, et al. Obstet & Gynecol 2011;117:877-882

Evidence-Based Best Practice # 1: Allsurgical patients will receive a minimumdose of 2 gram unless their BMI is >30 –

Then the correct dose is 3 grams (1Apharmacologically – weight adjusted)

Risk Reduction Begins on the Front End

7 Sentinel Studies?

• No routine standard of practice

• No evidence of patient compliance

• Heterogeneous study population

• Some individuals showered once, othersmultiple times

Webster J, Osborne S. The Cochrane Collaboration. The Cochrane Library. 2009;4:1-34.

Revisiting the Preadmission(Preoperative) Shower

Revisiting the Preadmission(Preoperative) Shower

Study 1 Study 2 Study 3 Study 4

CombinedResults

Meta-Analysis

Mean Chlorhexidine Gluconate (CHG) Skin SurfaceConcentrations (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 = 90b Pilot group N = 30

Edmiston et al, J Am Coll Surg 2008;207:233-239Edmiston et al, AORNJ 2010;92:509-518

What is the Evidence-BasedArgument?

Presurgical Skin Preparations as a Pathwayto Improving Surgical Outcomes

Presurgical Skin Preparations as a Pathwayto Improving Surgical Outcomes

• Reducing the risk of SSI in orthopaedic surgery• Standardized precleansing initiative (CHG cloths) in total joint patients

(night before/morning of surgery)

• SSI rate prior to intervention – 3.2% (N=727)

• SSI rate post intervention – 1.6% (N=824) 50% reduction p<0.01

Eiselt – Orthopaedic Nursing 2009;28:141-145

• Bundling risk reduction strategies – Quality initiative• MRSA prescreening in orthopaedic, obstetric, bariatric patients –

decolonization

• Presurgical antisepsis (CHG cloths) prior to surgery

• Preintervention SSI rate 1.6% (N=17/1,095) vs postintervention SSI rate0.57% (N=7/1,225 ) >60% reduction

• MRSA SSI rate 0.73% vs 0.16% >75% reduction p<0.01Lipke VL, Hyott AS. AORNJ 2010’;62:288-296

Institutional Prescreening for Detection and CHGEradication of 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

Study Period

6/2006-9/2007

Control Period

10/2005-6/2006

p value

N 7019 5293

MRSA Infection 4 (0.06%) 10 (0.18%) 0.0315

MSSA Infection 9 (0.13%) 14 (0.26%) 0.0937

Total SSIs 13 (0.18%) 24 (0.46%) 0.0093

Measuring Patient Compliance - 2011Measuring Patient Compliance - 2011

• All patients undergoing elective surgical procedures take 2CHG preadmission showers/cleansing

• 100 random orthopaedic and vascular patients queried as towhether or not they complied with preoperative instructions

• 71 indicated that they had taken two showers/cleansing

• 19 indicated that they took one shower (morning prior toadmission 15/19)

• 10 indicated they did not use CHG at all

• Reasons for non-compliance

• Forgot

• Thought one shower would be sufficient

• Didn’t realize it was that important

Evidence-Based Best Practice # 2: Allpatients undergoing an elective surgicalprocedure will take a minimum of 2 CHG

antiseptic shower/cleansings using astandardized regimen – The CHG must be

provided to the patient by the hospital

DESIGN: A PROSPECTIVE, RANDOMIZED, MULTICENTERCLINICAL TRIAL OF 2% CHLORHEXIDINE GLUCONATE /70% ISOPROPYL ALCOHOL (Alc-CHG) VS POVIDONE-IODINE (PI) FOR PREVENTION OF SSI

DESIGN: A PROSPECTIVE, RANDOMIZED, MULTICENTERCLINICAL 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 ofWisconsin, Milwaukee, Veterans Affairs Medical Center, Atlanta, Baylor Collegeof 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 vs8.6% 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-contaminatedprocedures

New England Journal of Medicine 2010;362:18-26

Why Should We Consider ChlorhexidineGluconate (CHG)?

Why Should We Consider ChlorhexidineGluconate (CHG)?

• Persistent antimicrobial activity for up to 6 hours 1, 5

• Documented residual activity and repeat applications will maximizeantimicrobial 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 tissueproteins 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. 4thEd., Lea & Febiger, Williams & Wilkins, Media PA, 1991:279; 4. Mangram AJ, et al., Guideline forprevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital InfectionControl Practices Advisory Committee, Atlanta GA.; 5. Edmiston CE et al. Am J Infection Control2007;35:89.

Evidence-Based Best Practice # 3:Alcohol/chlorhexidine gluconate

represents the state-of-the-art skinantiseptic agent (1A)

Please Note: Froedtert services using Alcohol/CHG forskin antisepsis: general, vascular, CT, orthopaedic,urology, neurosurgery, OB/GYN, hepatobiliary, solidorgan transplant

Is There an Evidence-BasedRationale for Antimicrobial Wound

Closure Technology as a Risk-Reduction Strategy?

J Am Coll Surg 2006;203:481-489

Utilizing Innovative Impregnated Technology to Reduce theRisk of Surgical Site Infections

Mean Microbial Recovery from Standard PolyglactinSutures Compared to Triclosan (Antimicrobial)-Coated

Polyglactin Closure Devices

0

25

50

75

100

125

150

175

200

225

250

275

300

Exposure Time 2 Minutes

S. aureus(MRSA)

E. coli

SP

TCP

p<0.01

102 105 102 105 102 105

N=10

Mean

co

lon

yfo

rmin

gu

nit

s(c

fu)/

cm

su

ture

S. epidermidisRP62A

Edmiston et al, J Am Coll Surg 2006;203:481-489

Adherence of Methicillin-Resistant Staphylococcusaureus (MRSA) to Braided Suture

Edmiston et al, Surgical Microbiology Research Laboratory, Milwaukee – APIC 2004

Extrinsic Risk Factor: Bacterial Colonizationof Implantable Devices (Sutures)

Extrinsic Risk Factor: Bacterial Colonizationof Implantable Devices (Sutures)

• Sutures are foreign bodies – can be colonized by Gram +/- bacteria

• Implants provide nidus for bacterial adherence

• Bacterial colonization can lead to biofilm formation

• Biofilm formation enhances antimicrobial recalcitrance

As little as 100 staphylococcican initiate a device-relatedinfection

Ward KH et al. J Med Microbiol. 1992;36: 406-413.Kathju S et al Surg infect. 2009;10:457-461Mangram AJ et al. Infect Control Hosp Epidemiol.1999;27:97-134

Edmiston CE, Problems in General Surgery 1993;10: 444

Impact of Implant on Minimal BactericidalConcentration (MBC- µg/mL) on Five Antibiotics

Against Staphylococcus epidermidis

Strains / Drug MBC in TSB MBC on Dacron

S. epidermidis RP12Nafcillin 16 >64Vancomycin 8 >512Cefazolin 8 >512Ampicillin/sulbactam 4 >512Rifampin 0.02 >32

S. epidermidis RP62ANafcillin 32 >64Vancomycin 16 >512Cefazolin 32 >512Ampicillin/sulbactam 16 >512Rifampin 2 >32

Edmiston CE, Problems in General Surgery 1993;10: 444

Making an Evidence-Based Argument forAntimicrobial (Triclosan) Coated SuturesMaking an Evidence-Based Argument forAntimicrobial (Triclosan) Coated Sutures

1. Ford et al. Pediatric surgery- Surg Infect 2005;3:3132. Rozzelle et al. Cerebro-spinal shunt surgery – J Neurosurg Pediatr 2008;2:111-

1117.3. Mingmalairak et al. Appendectomy – J Med Assoc Thai 2009;92:770-775.4. Zhuang et al. Abdominal surgery – J Clin Rehab Tiss Eng Res 2009;13:4045-

4048.5. Zhang et al. Radical mastectomy – Chin Med J 2011;124:719-724.6. Galal et al. General, GI surgery - Am J Surg 2011;202:133-138.7. Rasic et al. Colorectal surgery – Colleg. Antropologicum 2011;35:439-443.8. Williams et al. Breast CA surgery – Surg Infect 2011;12:469-474.9. Barac et al. Colorectal surgery – Surg Infect 2011;12:483-489.10. Isik et al. Cardiac surgery – Heart Surg Forum 2012;15:E40-E45.11. Turtainen et al. Lower limb revascularization surgery – World J Surgery 2012;

May 23 [Epub ahead of print].12. Seim BE et al. Cardiac surgery – Interact Cardiovasc Thorac Surg 2012: June 12

[Epub ahead of print].13. Nakamura T, et al. Colorectal surgery – Surgery 2013 [Epub ahead of print].14. Laas E, et al. Breast surgery – Int J Breast Cancer 2012 [Epub ahead of print].15. Justinger et al. Abdominal wall closure – In Press 2013 Surgery

Wang et al., BJS 2013; 100:465-473

Edmiston CE et al., In Press 2013 Surgery

Surgery In Press 2013

Is There an Evidence-Based Argument for Embracing anAntimicrobial (Triclosan) Coated Suture Technology for Reducing

the Risk of Surgical Site Infections (SSI): A Meta-analysis?

Is There an Evidence-Based Argument for Embracing anAntimicrobial (Triclosan) Coated Suture Technology for Reducing

the Risk of Surgical Site Infections (SSI): A Meta-analysis?

• Systematic literature review (SLR); 13 randomized controlled clinical trials(RCTs); 3,568 patients• PubMed, Embase/Medicine, Cochrane Database group, www.clinicaltrials.gov• Intention to treat (ITT) analysis• Fixed and random-effect model, pooled estimates reported as risk ratio (RR)• Publication bias assessed by Funnel plot of individual studies and testing theEgger regression intercept• Fixed-effect RR=0.734; 95CI: 0.590-0.913; p=0.005• Random-effect RR=0.693; 95CI: 0.533-0.920; p=0.011• No publication bias detected (Egger intercept, p=0.145)• Use of triclosan-coated sutures was associated with a significant reduction insurgical site infections in clean and clean-contaminated surgical cases –Cochrane level 1A evidence

Edmiston, Daoud, Leaper, In Press 2013: Surgery

Edmiston, Daoud, Leaper, In Press 2013: Surgery

Evidence-Based Best Practice # 4: Amyriad of randomized control trials

including two independent meta-analysissupport the adoption of an antimicrobial

closure technology as part of a thoughtful,integrated, evidence-based risk-reduction

strategy (IA)

Building the Next Evidence-BasedInitiative

“The Solution to Pollution is Dilution”

But a Documented Antiseptic Activity Doesn’t Hurt!

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

Impact of Intraoperative Irrigation on Resolutionof Mesh Contaminated Animal Model

Impact of Intraoperative Irrigation on Resolutionof Mesh Contaminated Animal Model

Study Group IrrigationFluid

BacterialIsolates

InitialChallenge

StudyPopulation , N= animals at 7days

1 Saline(Control)

MRSA ~3.7 log10 CFU 8

2 0.05% CHGa MRSA ~3.7 log10 CFU 8

Study Group Positive Recovery at7 days (log10 CFU)

Negative Recoveryat 7 day (log10 CFU)

Biofilm Formation(log10 CFU)

Saline 8/8, 4.26 log10 CFU No, 0/8 8/8, 6.3 log10 CFU

0.05% CHG 1/8 ,1.8 log10 CFUp<0.001

Yes, 7/8 2/8, 2.6 log10 CFUp<0.01

Edmiston CE, et al., In Press 2013 Am J Infect Controla Irrisept®

Thoughtful Approach to Adjunctive RiskReduction: 6 Point Interventional Process (SCIP +

nBest Practice)

Thoughtful Approach to Adjunctive RiskReduction: 6 Point Interventional Process (SCIP +

nBest Practice)

• MSSA & MRSA (selective) active surveillance - EB

• CHG shower or cleansing – EB

• CHG/Alc – Perioperative - EB

• Augment antibiotic dosing – 2 to 3 grams – EB

• CHG intraoperative irrigation (0.05%) – TBD

• Antimicrobial wound closure technology – EB

Improving Patient Outcome Requires

Commitment & Innovation

ConclusionsConclusions• Process measures are here to stay, we must

learn to live with them.

• Accurate outcomes measures are moreimportant – Improvements in surgical outcomeswill not come cheap – But the investment will stillbe (much) cheaper than the fiscal and morbidcosts to our patients.

• There are no “magic bullets” but innovative riskreduction strategies if “bundled” appropriatelywill at least guide us towards the “promisedland.”