View
1
Download
0
Category
Preview:
Citation preview
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.”
Recommended