Using Traditional and Using Traditional and Innovative Risk Reduction Innovative Risk Reduction

Strategies to Reduce the Risk Strategies to Reduce the Risk of SSIs in a Transparent and of SSIs in a Transparent and Evidence-Based Healthcare Evidence-Based Healthcare

EnvironmentEnvironment

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

Department of Surgery Medical College of WisconsinDepartment of Surgery Medical College of WisconsinMilwaukee, Wisconsin USAMilwaukee, Wisconsin USA

edmiston@mcw.eduedmiston@mcw.edu

Froedtert Hospital Infection Control TeamFroedtert Hospital Infection Control Team2011 - 2012 2011 - 2012

Chairman, Infection Control Chairman, Infection Control CommitteeCommittee Mary Beth Graham, MDMary Beth Graham, MD

Infection Control CoordinatorsInfection Control Coordinators Patti Wilson, BSN, CICPatti Wilson, BSN, CIC Pat Sadenwasser, BSN, CICPat Sadenwasser, BSN, CIC Amy Macke, BSN, CICAmy Macke, BSN, CIC

MicrobiologistsMicrobiologists Nathan Ledeboer, PhD, D-ABMMNathan Ledeboer, PhD, D-ABMM Candy Krepel, MS, SM-ASCP, CICCandy Krepel, MS, SM-ASCP, CIC

Hospital EpidemiologistHospital Epidemiologist Charles Edmiston, PhD, CICCharles Edmiston, PhD, CIC

Administrative SupportAdministrative Support Donna Welter, CMSMDonna Welter, CMSM

““Risk Reduction Requires an Risk Reduction Requires an Understanding of the Mechanistic Factors Understanding of the Mechanistic Factors which Potentiate the Risk of Infection in which Potentiate the Risk of Infection in

the Surgical Patient Population” the Surgical Patient Population”

Health Care-Associated InfectionsHealth Care-Associated InfectionsHealth Care-Associated InfectionsHealth Care-Associated Infections• NPSG.07.03.01NPSG.07.03.01: Implement evidence-based practices : Implement evidence-based practices

to prevent health care-associated infections due to to prevent health care-associated infections due to multidrug-resistant organisms in acute care multidrug-resistant organisms in acute care organizations (critical access facilities).organizations (critical access facilities).

• NPSG.07.04.01NPSG.07.04.01: Implement evidence-based practices : Implement evidence-based practices to prevent central line-associated bloodstream to prevent central line-associated bloodstream infections (critical access and long-term care facilities).infections (critical access and long-term care facilities).

• NPSG.07.05.01NPSG.07.05.01: Implement evidence-based practices : Implement evidence-based practices for preventing surgical site infections (critical care, for preventing surgical site infections (critical care, ambulatory and office-based surgical facilities).ambulatory and office-based surgical facilities).

2010 National Patient Safety Goals 2010 National Patient Safety Goals (NPGS) – The Joint Commission(NPGS) – The Joint Commission

Evidence-Based HierarchyEvidence-Based Hierarchy

Mitigating Risk - Surgical Mitigating Risk - Surgical Care Improvement Project Care Improvement Project

(SCIP) – An Evidence-Based (SCIP) – An Evidence-Based ApproachApproach

Mitigating Risk - Surgical Mitigating Risk - Surgical Care Improvement Project Care Improvement Project

(SCIP) – An Evidence-Based (SCIP) – An Evidence-Based ApproachApproach

• Timely and appropriate Timely and appropriate antimicrobial prophylaxis antimicrobial prophylaxis

• Glycemic control in cardiac Glycemic control in cardiac and vascular surgery and vascular surgery

• Appropriate hair removalAppropriate hair removal• Normothermia in general Normothermia in general

surgical patientssurgical patients

Is this the Holy Grail?Is this the Holy Grail?

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

Site Infection in Colorectal SurgerySite Infection in Colorectal Surgery

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

““The report by Stulberg et al in this The report by Stulberg et al in this issue of issue of JAMAJAMA is the largest study to is the largest study to date that fails to demonstrate an date that fails to demonstrate an association between adherence to association between adherence to SCIP process measures and the SCIP process measures and the occurrence of postoperative infections. 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 Despite substantial improvements in SCIP substantial improvements in SCIP adherence over the 2-year study adherence over the 2-year study period, postoperative infection rates period, postoperative infection rates actually increasedactually increased.”.”

MT Hawn – Editorial JAMAMT Hawn – Editorial JAMA

Does the Process Improve the Outcome?Does the Process Improve the Outcome?

The author’s analysis suggest that, The author’s analysis suggest that, “…there was little or no association “…there was little or no association between compliance with most between compliance with most SCIP infection-related process SCIP infection-related process measures and ACS NSQIP risk-measures and ACS NSQIP risk-adjusted outcome…….with the adjusted outcome…….with the exception of administration of the exception of administration of the appropriate antibiotic (SCIP-2).”appropriate antibiotic (SCIP-2).”

Ingraham et al. J Am Coll Surg 2010;211:705-711

Taking a SCIP-Plus Perspective to Taking a SCIP-Plus Perspective to Risk ReductionRisk Reduction

Does increase BMI warrant a Does increase BMI warrant a change in how we dose change in how we dose

(prophylactic) our patients?(prophylactic) our patients?

Toma et al., Anesthetic Pharmacology and Preclinical Pharmacology 2011;113:730-737Toma et al., Anesthetic Pharmacology and Preclinical Pharmacology 2011;113:730-737

“Measured and dose-normalized subcutaneous cefoxitin concentrations and AUCs in the obese patients were significantly lower than in the normal-weight subjects. There was an inverse relationship between cefoxitin tissue penetration (AUC tissue/ AUC plasma ratio) and body mass index. Tissue penetration was substantially lower in the obese patients compared to normal weight controls (p = 0.05).”“This occurred despite 2-fold-higher cefoxitin dosage (1 to 2 gms). Diminished tissue antibiotic concentrations in morbid obesity may influence the incidence of SSIs.”

Percent Therapeutic Activity of Serum/Tissue Concentrations Compared to Percent Therapeutic Activity of Serum/Tissue Concentrations Compared to Surgical Isolate Susceptibility (2002-2004/2006-2009) to Cefazolin Following 2 Surgical Isolate Susceptibility (2002-2004/2006-2009) to Cefazolin Following 2

gm (N = 38) and 3 gm (N = 40) Perioperative Dosing Regimengm (N = 38) and 3 gm (N = 40) Perioperative Dosing Regimen

2-gm2-gmaa 3-gm 3-gmbb

OrganismOrganism N N SerumSerum Tissue Tissue N N Serum Tissue Serum Tissue

S. aureus S. aureus 70 70 68.6% 27.1% 68.6% 27.1% 92 87.5% 68.5% 92 87.5% 68.5%

S. epidermidis S. epidermidis 110 34.5% 10.9% 156 64.5% 49.6%110 34.5% 10.9% 156 64.5% 49.6%

E. coliE. coli 85 75.3% 56.4% 101 92.4% 86.5%85 75.3% 56.4% 101 92.4% 86.5%

Kl. pneumoniaeKl. pneumoniae 55 55 80% 80% 65.4% 49 96.8% 98.4%65.4% 49 96.8% 98.4%

aa period covering 2001-2003 period covering 2001-2003

bb period covering 2006-2009 period covering 2006-2009aaEdmiston et al, Surgery 2004;136:738-747Edmiston et al, Surgery 2004;136:738-747

bbEdmiston et al., In Press 2011: Surgical InfectionEdmiston et al., In Press 2011: Surgical Infection

Perioperative Antimicrobial Prophylaxis in Perioperative Antimicrobial Prophylaxis in Higher BMI (>30) Patients: Do We Achieve Higher BMI (>30) Patients: Do We Achieve

Therapeutic Levels?Therapeutic Levels?

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

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

Perioperative Cefazolin Prophylaxis Perioperative Cefazolin Prophylaxis During Cardiovascular Surgery: Are During Cardiovascular Surgery: Are

Therapeutic Levels Impacted by BMI?*Therapeutic Levels Impacted by BMI?*

Perioperative Cefazolin Prophylaxis Perioperative Cefazolin Prophylaxis During Cardiovascular Surgery: Are During Cardiovascular Surgery: Are

Therapeutic Levels Impacted by BMI?*Therapeutic Levels Impacted by BMI?*

Per

cen

t (%

)P

erce

nt

(%)

*% therapeutic level versus BMI and cefazolin breakpoint

Surgical Microbiology Research Laboratory 2011Surgical Microbiology Research Laboratory 2011

N = 10/GroupN = 10/Group

Best Practice # 1: All surgical Best Practice # 1: All surgical patients will receive a minimum dose patients will receive a minimum dose

of 2 gram unless their BMI is >30 – of 2 gram unless their BMI is >30 – Then the correct dose is 3 grams Then the correct dose is 3 grams

Please Note: All surgical procedures Please Note: All surgical procedures at Froedtert Hospital are viewed as at Froedtert Hospital are viewed as

SCIP-eligible proceduresSCIP-eligible procedures

Risk Reduction Begins on the Front-EndRisk Reduction Begins on the Front-EndQuantitativeQuantitative Microbial Recovery from the Skin Surface*Microbial Recovery from the Skin Surface*

Risk Reduction Begins on the Front-EndRisk Reduction Begins on the Front-EndQuantitativeQuantitative Microbial Recovery from the Skin Surface*Microbial Recovery from the Skin Surface*

• Scalp Scalp 6.0 Log6.0 Log1010 cfu/cm cfu/cm22

• Axilla Axilla 5.5 Log5.5 Log1010 cfu/cm cfu/cm22

• Abdomen Abdomen 4.3 Log4.3 Log1010 cfu/cm cfu/cm22

• ForearmForearm 4.0 Log4.0 Log1010 cfu/cm cfu/cm22

• HandsHands 4.0-6.6 Log4.0-6.6 Log1010 cfu/cm cfu/cm22

• Perineum Perineum 7.0-11.0 Log7.0-11.0 Log1010 cfu/cm cfu/cm22

**Surgical Microbiology Research Laboratory 2010 – Medical College of Wisconsin, Department of SurgerySurgical Microbiology Research Laboratory 2010 – Medical College of Wisconsin, Department of Surgery

Mean Chlorhexidine Gluconate (CHG) Skin Surface Mean Chlorhexidine Gluconate (CHG) Skin Surface Concentrations (Concentrations (µg/mlµg/ml++SD) Compared to MICSD) Compared to MIC9090 (5 µg/ml) (5 µg/ml)

for Staphylococcal Surgical Isolates Including MRSAfor Staphylococcal Surgical Isolates Including MRSAaa

Subgroups (mean C, Subgroups (mean C, µg/ml)µg/ml)

PilotPilotbb 1 2 1 2 Groups (4%) (4% Aqueous) (2% Cloths) [CGroups (4%) (4% Aqueous) (2% Cloths) [CCHGCHG/MIC/MIC9090] ] p-valuep-value

Group A (20)Group A (20)

evening (1X) 3.7evening (1X) 3.7++2.5 24.42.5 24.4++5.9 436.15.9 436.1++91.2 91.2 0.9 4.8 87.2 0.9 4.8 87.2 <0.001<0.001

Group B (20)Group B (20)

morning (1X) 7.8morning (1X) 7.8++5.6 79.25.6 79.2++26.5 991.326.5 991.3++58.2 58.2 1.9 15.8 198.2 1.9 15.8 198.2 <0.0001<0.0001

Group C (20)Group C (20)

both (both (2X2X) ) 9.99.9++7.1 126.47.1 126.4++19.4 1745.519.4 1745.5++204.3 204.3 2.5 25.3 349.1 2.5 25.3 349.1 <0.0001<0.0001

aa N = 90 N = 90b b Pilot group N = 30Pilot group N = 30

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

Preadmission Showering/Cleansing Skin Preadmission Showering/Cleansing Skin Preparations as a PathwayPreparations as a Pathway

to Improving Patient Outcomes (Evidence-Based)to Improving Patient Outcomes (Evidence-Based)

Preadmission Showering/Cleansing Skin Preadmission Showering/Cleansing Skin Preparations as a PathwayPreparations as a Pathway

to Improving Patient Outcomes (Evidence-Based)to Improving Patient Outcomes (Evidence-Based)• Reducing the risk of Reducing the risk of SSSSI in orthopaedic surgeryI in orthopaedic surgery

• Standardized precleansing initiative (CHG cloths) in total joint patients (night Standardized precleansing initiative (CHG cloths) in total joint patients (night before/morning of surgery) before/morning of surgery)

• 50% overall reduction in SSI50% overall reduction in SSIEiselt - Orthopaedic Nursing 2009;28:141-145Eiselt - Orthopaedic Nursing 2009;28:141-145

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

+ precleansing with 2% CHG+ precleansing with 2% CHG• >60% overall reduction in SSI>60% overall reduction in SSI• >75% reduction in MRSA SSI>75% reduction in MRSA SSI

Lipke VL Hyott AS. AORNJ 2010’;62:288-296Lipke VL Hyott AS. AORNJ 2010’;62:288-296

Best Practice # 2: All patients Best Practice # 2: All patients undergoing an elective surgical procedure undergoing an elective surgical procedure

will take a minimum of 2 CHG antiseptic will take a minimum of 2 CHG antiseptic shower/cleansings using a standardized shower/cleansings using a standardized regimen – The CHG must be supplied to regimen – The CHG must be supplied to

the patient by the hospitalthe patient by the hospital

Why Should We Consider Chlorhexidine Why Should We Consider Chlorhexidine Gluconate (CHG)?Gluconate (CHG)?

Why Should We Consider Chlorhexidine Why Should We Consider Chlorhexidine Gluconate (CHG)?Gluconate (CHG)?

• Persistent antimicrobial activity for up to 6 hours Persistent antimicrobial activity for up to 6 hours 1, 51, 5

• Documented residual activity and repeat applications will maximize Documented residual activity and repeat applications will maximize antimicrobial effect antimicrobial effect 2, 52, 5

• Rapid bactericidal action Rapid bactericidal action 3, 53, 5

• Has good to excellent activity against gram-positive and gram-Has good to excellent activity against gram-positive and gram-negative bacteria negative bacteria 4, 54, 5

• CHG activity is not adversely impacted by either blood or tissue CHG activity is not adversely impacted by either blood or tissue proteins proteins 55

1. Larson E, APIC guidelines for infection control practice: guideline for use of topical antimicrobial 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. 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 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 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 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 Control Practices Advisory Committee, Atlanta GA.; 5. Edmiston CE et al. Am J Infection Control 2007;35:89.2007;35:89.

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

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

Multi Center:Multi Center: Michael E. Debakey Veterans Affairs Medical Center, Ben Taub General Michael E. Debakey Veterans Affairs Medical Center, Ben Taub General Hospital, Houston, Veterans Affairs Medical Center, Boston, Hospital, Houston, Veterans Affairs Medical Center, Boston,

Medical College of Medical College of Wisconsin, Milwaukee, Veterans Affairs Medical Center, Atlanta, Wisconsin, Milwaukee, Veterans Affairs Medical Center, Atlanta, Baylor College Baylor College of Medicine, Houstonof Medicine, Houston

• Patients > 18 years, undergoing clean-contaminated procedures Patients > 18 years, undergoing clean-contaminated procedures (gastrointestinal, thoracic, urologic and gynecologic)(gastrointestinal, thoracic, urologic and gynecologic)• N = 849 surgical patients: 409 Alc-CHG vs 440 PIN = 849 surgical patients: 409 Alc-CHG vs 440 PI• 1:1 randomization1:1 randomization• Patients monitored for 30 days post-opPatients monitored for 30 days post-op• Overall rate of SSI was significantly reduced in Alc-CHG vs PI groups: 9.5% Overall rate of SSI was significantly reduced in Alc-CHG vs PI groups: 9.5% vs 16.1%, vs 16.1%, p=0.004p=0.004• Significant difference for both superficial incisional site rate: 4.2% A-CHG vs Significant difference for both superficial incisional site rate: 4.2% A-CHG vs 8.6% PI (8.6% PI (p=0.008p=0.008) and deep incisional: 1% A-CHG vs 3% PI () and deep incisional: 1% A-CHG vs 3% PI (p=0.05p=0.05))• No significant adverse events noted during the study in either groupNo significant adverse events noted during the study in either group• Alc-CHG superior to PI in reducing the risk of SSI in clean-contaminated Alc-CHG superior to PI in reducing the risk of SSI in clean-contaminated proceduresprocedures

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

Best Practice # 3: Best Practice # 3: Alcohol/chlorhexidine gluconate Alcohol/chlorhexidine gluconate

represents the state-of-the-art skin represents the state-of-the-art skin antiseptic agentantiseptic agent

Please Note: Froedtert services using Alcohol/CHG for Please Note: Froedtert services using Alcohol/CHG for skin antisepsis: general, vascular, CT, orthopaedic, skin antisepsis: general, vascular, CT, orthopaedic, urology, neurosurgery, OB/GYN, hepatobiliary, solid urology, neurosurgery, OB/GYN, hepatobiliary, solid organ transplant organ transplant

J Am Coll Surg 2006;203:481-489J Am Coll Surg 2006;203:481-489

Utilizing Innovative Impregnated Technology to Reduce the Utilizing Innovative Impregnated Technology to Reduce the Risk of Surgical Site InfectionsRisk of Surgical Site Infections

Mean Microbial Recovery from Standard Mean Microbial Recovery from Standard Polyglactin 910 Sutures (V) and Triclosan-Polyglactin 910 Sutures (V) and Triclosan-

Coated Polyglactin 910 Braided Sutures (VT)Coated Polyglactin 910 Braided Sutures (VT)

0

25

50

75

100

125

150

175

200

225

250

275

300

Exposure Time 2 MinutesExposure Time 2 Minutes

S. aureusS. aureus (MRSA)(MRSA)

E. coliE. coli

VV

VTVT

p<0.01p<0.01

101022 101055 101022 101055 101022 101055

N=10N=10

Mea

n c

olo

ny

form

ing

un

its

Mea

n c

olo

ny

form

ing

un

its

(cfu

)/cm

su

ture

(cfu

)/cm

su

ture

S. epidermidis S. epidermidis RP62ARP62A

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

Edmiston et al., J Am Coll Surg 2006;203;481-489; 2011Edmiston et al., J Am Coll Surg 2006;203;481-489; 2011

Mechanistic Benefits of Antimicrobial SuturesMechanistic Benefits of Antimicrobial Sutures

• Reduce risk of wound contaminationReduce risk of wound contamination• Reduction in device contaminationReduction in device contamination• Elution of antiseptic agent within the wound bedElution of antiseptic agent within the wound bed

Zones of Inhibition - Zones of Inhibition - S. aureus (MRSA)S. aureus (MRSA)

MonofilamentMonofilament

BraidedBraided

Staphylococcus epidermidisStaphylococcus epidermidis Incisional Wound Infection Incisional Wound Infection

Surgical Microbiology Research Laboratory, Milwaukee - 2005 Surgical Microbiology Research Laboratory, Milwaukee - 2005

Are Sutures Really a Nidus for Infection?Are Sutures Really a Nidus for Infection?

Percent Sutures Recovered from Infected Percent Sutures Recovered from Infected Cases and Mean Microbial Recovery from Cases and Mean Microbial Recovery from Explanted Absorbable / Non-Absorbable Explanted Absorbable / Non-Absorbable

Devices* Devices*

*29/65 (44.6%) nylon skin sutures were culture positive but not infected [mean microbial recovery = 1,674 (3.2 log10 cfu/cm suture)]; NS between non-infected and infected nylon sutures 

Poliglecaprone (skin, fascia, Poliglecaprone (skin, fascia, n=13)n=13)

Polyglactin (fascia, Polyglactin (fascia, n=14)n=14)

5/185/18

5/135/13

4/144/14

22/3722/37

4/114/11

6/656/65

Polydioxanone (fascia, Polydioxanone (fascia, n=18)n=18)

38.5%38.5%

27.7%27.7%

Nylon (skin, Nylon (skin, n=65)n=65)

Nylon (fascia, n=11) Nylon (fascia, n=11)

Polypropylene (fascia, Polypropylene (fascia, n=37)n=37)

28.5%28.5%

59.5%59.5%

36.4%36.4%

9.2%9.2%

Percent Infected CasesPercent Infected Cases Microbial Recovery (log Microbial Recovery (log 1010 cfu/cm suture) cfu/cm suture)

6.3

5.9

6.9

5.1

5.6

4.9

5

Presence of Biofilm on Selected Sutures Presence of Biofilm on Selected Sutures from from

Non-Infected and Infected CasesNon-Infected and Infected Cases P

rese

nce

of

Bio

film

(%

)P

rese

nce

of

Bio

film

(%

)

aa16 non-infected nylon suture segments were randomly selected for microscopy16 non-infected nylon suture segments were randomly selected for microscopybb4 infected braided suture segments were randomly selected for microscopy4 infected braided suture segments were randomly selected for microscopy

cc12 infected monofilament suture segments were randomly selected for microscopy12 infected monofilament suture segments were randomly selected for microscopy

Non-Infected CasesNon-Infected Cases (Nylon = 16) (Nylon = 16) a a

Infected Cases Infected Cases Superficial SSI Deep Incisional SSI Superficial SSI Deep Incisional SSI

(N = 8) (N = 8) (N = 8)(N = 8)

Nylon Nylon aa

Braided Braided bb

Monofilament Monofilament cc

SUTURESSUTURES

62.5

100 100 100 100

62.5

100 100 100 100

Making an Evidence-Based Argument for Making an Evidence-Based Argument for Antimicrobial (Triclosan) Coated SuturesAntimicrobial (Triclosan) Coated SuturesMaking an Evidence-Based Argument for Making an Evidence-Based Argument for Antimicrobial (Triclosan) Coated SuturesAntimicrobial (Triclosan) Coated Sutures

Safety Safety 1.1. Ford et alFord et al. Intraoperative handling and wound healing…… . Intraoperative handling and wound healing…… Surg Infect 2005;3:313Surg Infect 2005;3:313Clinical EfficacyClinical Efficacy2.2. Edmiston et alEdmiston et al. Bacterial adherence to surgical sutures:. Bacterial adherence to surgical sutures:……Surgery 2006;203:481Surgery 2006;203:481..3.3. Rozzelle at al. Rozzelle at al. Antimicrobial sutures for wound closure in CSF shunt surgery…… Antimicrobial sutures for wound closure in CSF shunt surgery…… J J

Neurosurg 2008;42:111Neurosurg 2008;42:1114.4. Pico et al. Pico et al. Incisional closure following appendectomy in children….Incisional closure following appendectomy in children….Pediatric Surg Pediatric Surg

2008;21:1992008;21:1995.5. Justinger et al. Justinger et al. Antimicrobial coating of abdominal closure sutures and infection….. Antimicrobial coating of abdominal closure sutures and infection…..

Surgery 2009;145:330Surgery 2009;145:3306.6. Mingmalairak et alMingmalairak et al. Efficacy of antimicrobial coated sutures in reducing SSI following . Efficacy of antimicrobial coated sutures in reducing SSI following

appendectomy. appendectomy. J Med Assoc Thai 2009;92:770J Med Assoc Thai 2009;92:7707.7. Chao-ping et alChao-ping et al. Comparison of two absorbable sutures for abdominal wall closure. . Comparison of two absorbable sutures for abdominal wall closure. J Clin J Clin

Rehab Tissue Eng Research 2009;13:4045Rehab Tissue Eng Research 2009;13:40458.8. Galal et al. Galal et al. Impact of using triclosan-antibacterial sutures on incidence of surgical site Impact of using triclosan-antibacterial sutures on incidence of surgical site

infection. infection. Am J Surgery 2011;202:133-138Am J Surgery 2011;202:133-138Economic BenefitEconomic Benefit9.9. Fleck et al. Fleck et al. Triclosan-coated sutures for reduction of sternal wound infection….Triclosan-coated sutures for reduction of sternal wound infection….Ann Thor Ann Thor

Surg 2007;84:232Surg 2007;84:23210.10. Stone et al. Stone et al. Healthcare saving associated with reduced infection in CSF shunt Healthcare saving associated with reduced infection in CSF shunt

procedures….procedures….Pediatric Neurosurg 2009;46:19-24Pediatric Neurosurg 2009;46:19-24

• An Accumulation of Evidence-Base Outcome DataAn Accumulation of Evidence-Base Outcome Data

16 Published clinical studies (12 independent investigator initiated)16 Published clinical studies (12 independent investigator initiated)• 9 RCTs (Randomized Controlled Trials)9 RCTs (Randomized Controlled Trials)• 66 NRCTs (Non-Randomized Controlled Trials)NRCTs (Non-Randomized Controlled Trials)• 1 Economic Evaluation of a Trial Previously Reported (Stone et 1 Economic Evaluation of a Trial Previously Reported (Stone et

al) al) • 1010 + studies in progress+ studies in progress

• Independent initiated as well as industry fundedIndependent initiated as well as industry funded• Including robust hypothesis-testing RCTsIncluding robust hypothesis-testing RCTs• Multiple specialties (CV, GS, Ortho, Breast)Multiple specialties (CV, GS, Ortho, Breast)• Multiple international venuesMultiple international venues

Antimicrobial Suture Technology – Emerging Antimicrobial Suture Technology – Emerging Evidence of Clinical EfficacyEvidence of Clinical Efficacy

Meta-Analysis – Random Effects ModelMeta-Analysis – Random Effects ModelMeta-Analysis – Random Effects ModelMeta-Analysis – Random Effects Model

-- p = 0.0012

““Although use of antimicrobial sutures is not a Although use of antimicrobial sutures is not a routine practice, the benefits are becoming routine practice, the benefits are becoming

increasingly apparent. Recent evidence-based increasingly apparent. Recent evidence-based clinical studies have demonstrated both the clinical clinical studies have demonstrated both the clinical

and economic benefit of this technology.” APIC and economic benefit of this technology.” APIC 2010 Orthopaedic Risk Reduction Guidelines – 2010 Orthopaedic Risk Reduction Guidelines –

However, it should never be viewed as a “Magic However, it should never be viewed as a “Magic Bullet” but rather a component of a thoughtful, Bullet” but rather a component of a thoughtful,

evidence-based risk reduction stratgeyevidence-based risk reduction stratgey

A Special Consideration: Device-A Special Consideration: Device-Related Breast Infections – Building Related Breast Infections – Building

an Evidence-Based Intervention an Evidence-Based Intervention

Considering the Risk and Microbial Considering the Risk and Microbial Epidemiology of Breast Infections: Non-Epidemiology of Breast Infections: Non-

Device versus Device-RelatedDevice versus Device-Related

• Operative closure and SSI in women undergoing breast conserving therapy Operative closure and SSI in women undergoing breast conserving therapy (N=580) -11.7% (superficial) vs. 5.2% (full-thickness) (N=580) -11.7% (superficial) vs. 5.2% (full-thickness)

Indelicato et al, Surgery 2007;141:645Indelicato et al, Surgery 2007;141:645

• Economic burden N=949): mastectomy with immediate reconstruction Economic burden N=949): mastectomy with immediate reconstruction (implant) – 12.4% vs. mastectomy only – 4.4% vs. breast reduction – 1.1% - (implant) – 12.4% vs. mastectomy only – 4.4% vs. breast reduction – 1.1% - Suboptimal antimicrobial prophylaxis modifiable risk factorSuboptimal antimicrobial prophylaxis modifiable risk factor

Olsen et al, J Am Coll Surg 2008;207:326Olsen et al, J Am Coll Surg 2008;207:326

• Breast augmentation (N=3,002) – 1.1% (<1.0%-2.5%): modifiable risk factor – Breast augmentation (N=3,002) – 1.1% (<1.0%-2.5%): modifiable risk factor – drains drains

Araco et al, Aesthetic Plastic Surgery 2007;31:325Araco et al, Aesthetic Plastic Surgery 2007;31:325

Considering the Risk and Microbial Considering the Risk and Microbial Epidemiology of Breast InfectionsEpidemiology of Breast Infections

““Is cefazolin sufficient in breast implant surgery“ – Feldman et al, Plast Reconstr Surg 2010;126:779Is cefazolin sufficient in breast implant surgery“ – Feldman et al, Plast Reconstr Surg 2010;126:779

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

Building an Evidence-Based Risk Building an Evidence-Based Risk Reduction Strategy for Breast Reduction Strategy for Breast

Reconstruction – A 6 Point StrategyReconstruction – A 6 Point Strategy

Building an Evidence-Based Risk Building an Evidence-Based Risk Reduction Strategy for Breast Reduction Strategy for Breast

Reconstruction – A 6 Point StrategyReconstruction – A 6 Point Strategy• CHG shower or cleansing - EBCHG shower or cleansing - EB• Augment antibiotic dosing – 2 to 3 grams - EBAugment antibiotic dosing – 2 to 3 grams - EB• Alc/CHG perioperative antisepsis – EBAlc/CHG perioperative antisepsis – EB• Antimicrobial (CHG) dressing post JP insertion - TBDAntimicrobial (CHG) dressing post JP insertion - TBD• CHG irrigation (0.05%) - TBDCHG irrigation (0.05%) - TBD• Antimicrobial closure technology - EBAntimicrobial closure technology - EB

Improving Patient Outcome Requires One Improving Patient Outcome Requires One

To “Think Different”To “Think Different”

The Mechanistic Etiology of a Surgical The Mechanistic Etiology of a Surgical Site Infection – Let Me Count the WaysSite Infection – Let Me Count the WaysThe Mechanistic Etiology of a Surgical The Mechanistic Etiology of a Surgical Site Infection – Let Me Count the WaysSite Infection – Let Me Count the Ways

• The patient’s own endogenous flora – skin antisepsisThe patient’s own endogenous flora – skin antisepsis• Intrinsic versus extrinsic considerationsIntrinsic versus extrinsic considerations

- Inadequate sterilization/disinfection- Inadequate sterilization/disinfection

- Breaks in sterile technique - Breaks in sterile technique

- Nasopharyngeal shedding- Nasopharyngeal shedding

- Microperforation of surgical gloves- Microperforation of surgical gloves

Looking at the Risk of Surgical Site Infections Looking at the Risk of Surgical Site Infections from a New Mechanistic Perspectivefrom a New Mechanistic Perspective

Surgical Glove Perforation and the Risk of Surgical Site Surgical Glove Perforation and the Risk of Surgical Site Infection – Analysis of 4147 Surgical CasesInfection – Analysis of 4147 Surgical Cases

Looking at the Risk of Surgical Site Infections Looking at the Risk of Surgical Site Infections from a New Mechanistic Perspectivefrom a New Mechanistic Perspective

Surgical Glove Perforation and the Risk of Surgical Site Surgical Glove Perforation and the Risk of Surgical Site Infection – Analysis of 4147 Surgical CasesInfection – Analysis of 4147 Surgical Cases

• Compared to a control group logistic regression model documented a higher Compared to a control group logistic regression model documented a higher likelihood of SSI in procedures in which surgical gloves were perforated and likelihood of SSI in procedures in which surgical gloves were perforated and errors had occurred in antimicrobial prophylaxis (adjusted OR, 4.2; 95% CI, errors had occurred in antimicrobial prophylaxis (adjusted OR, 4.2; 95% CI,

1.7-10.8; 1.7-10.8; P=0.003P=0.003). ).

Misteli et al. Arch Surgery 2009;144:553-558Misteli et al. Arch Surgery 2009;144:553-558

Bacteria Passage Following Surgical Glove PerforationBacteria Passage Following Surgical Glove Perforation• Over a 4 month interval the microperforation rate of the outer layer ranged from 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 4.7% to 28% - allowing bacterial passage across the surgical glove into the surgical wound.surgical wound.

Harmob et al. Am J Infect Control 2010;38:154-158

Outer mechanical layerOuter mechanical layer

Middle layer including the Middle layer including the antimicrobial liquid in drop-antimicrobial liquid in drop-

like compartmentslike compartments

Inner mechanical layerInner mechanical layer

Integrated Antimicrobial Surgical Integrated Antimicrobial Surgical Glove TechnologyGlove Technology

Skin (hand)Skin (hand)

Sonntag et al., Nature Materials 2004;3:311-315

Krikorian R, J Hosp Infect 2007;66:339-345

Mean Microbial (Mean Microbial (S. aureusS. aureus) Recovery ) Recovery (cfu/ml) at 10 and 45 Minutes Post (cfu/ml) at 10 and 45 Minutes Post Surgical Glove Microperforation*Surgical Glove Microperforation*

Mean Microbial (Mean Microbial (S. aureusS. aureus) Recovery ) Recovery (cfu/ml) at 10 and 45 Minutes Post (cfu/ml) at 10 and 45 Minutes Post Surgical Glove Microperforation*Surgical Glove Microperforation*

*N = 24 gloves per group *N = 24 gloves per group

p<0.05p<0.05

NSNS

p<0.005p<0.005

p<0.005p<0.005

292292

418418

351351

18018024.524.5

1.41.4

Daeschlein and Edmiston – Am J Infect Control 2011;39:98-103

cfu/

ml

Why Should an Antimicrobial Surgical Glove Why Should an Antimicrobial Surgical Glove be Viewed as a Risk Reduction Strategybe Viewed as a Risk Reduction Strategy

Why Should an Antimicrobial Surgical Glove Why Should an Antimicrobial Surgical Glove be Viewed as a Risk Reduction Strategybe Viewed as a Risk Reduction Strategy

Viewing Risk from a Mechanistic PerspectiveViewing Risk from a Mechanistic Perspective

• Microperforation rates exceed 25% in selective surgical Microperforation rates exceed 25% in selective surgical servicesservices

• Microbial rebound (hand) occurs in all surgical casesMicrobial rebound (hand) occurs in all surgical cases• Perforation rates highest in non-dominant hand (thumb Perforation rates highest in non-dominant hand (thumb

and index finger)and index finger)• Wound bed vulnerable to contamination – hyperglycemia Wound bed vulnerable to contamination – hyperglycemia

and corticosteroids diminish wound defenses and corticosteroids diminish wound defenses • Biomedical devices at high risk for contamination – 40% Biomedical devices at high risk for contamination – 40%

of SSI discovered beyond 30 daysof SSI discovered beyond 30 days

Caveat - Surgical site infections Caveat - Surgical site infections represent a complex and multi-represent a complex and multi-

factorial process - the mechanistic factorial process - the mechanistic etiology is quite often elusive, etiology is quite often elusive, requiring innovative solutions requiring innovative solutions

Era of Surgical Transparency – Era of Surgical Transparency – NHSN and CMS (308d Participation NHSN and CMS (308d Participation

and Consent Document)and Consent Document)

A New Era of Transparency – A Surgeon’s A New Era of Transparency – A Surgeon’s PerspectivePerspective

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

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

• SSI risk factors in inflammatory bowel SSI risk factors in inflammatory bowel patients undergoing colorectal procedures = patients undergoing colorectal procedures = >15% (>15% (Diseases Colon & Rectum Diseases Colon & Rectum 2007;50:3312007;50:331))

• Post-cesarean surgical site infection rate – Post-cesarean surgical site infection rate – 8.9% (post-discharge) vs 1.8% at hospital 8.9% (post-discharge) vs 1.8% at hospital discharge (discharge (Acta Obstet Gynecol Acta Obstet Gynecol 2007;86:10972007;86:1097))

Thinking outside of the box – impact of BMI, diminished Thinking outside of the box – impact of BMI, diminished granulocytic cell functiongranulocytic cell function

The Pogo Effect – The Pogo Effect – “Yep, we have met “Yep, we have met the enemy and he the enemy and he

is us”is us”