Using Traditional and
Innovative Risk Reduction
Strategies to Reduce the Risk
of SSIs in a Transparent and
Evidence-Based Healthcare
Environment
Charles E. Edmiston Jr., PhD., CIC
Professor of Surgery & Hospital Epidemiologist Department of Surgery Medical College of Wisconsin
Milwaukee, Wisconsin USA
edmiston@mcw.edu
Froedtert Hospital Infection Control Team
2011 - 2012
Chairman, Infection Control
Committee
Mary Beth Graham, MD
Infection Control Coordinators
Patti Wilson, BSN, CIC
Pat Sadenwasser, BSN, CIC
Amy Macke, BSN, CIC
Microbiologists
Nathan Ledeboer, PhD, D-ABMM
Candy Krepel, MS, SM-ASCP, CIC
Hospital Epidemiologist
Charles Edmiston, PhD, CIC
Administrative Support
Donna Welter, CMSM
“Risk Reduction Requires an
Understanding of the Mechanistic Factors
which Potentiate the Risk of Infection in
the Surgical Patient Population”
2010 National Patient Safety Goals
(NPGS) – The Joint Commission
Health Care-Associated Infections
•
•
•
NPSG.07.03.01: Implement evidence-based practices
to prevent health care-associated infections due to
multidrug-resistant organisms in acute care
organizations (critical access facilities).
NPSG.07.04.01: Implement evidence-based practices
to prevent central line-associated bloodstream
infections (critical access and long-term care facilities).
NPSG.07.05.01: Implement evidence-based practices
for preventing surgical site infections (critical care,
ambulatory and office-based surgical facilities).
Evidence-Based Hierarchy
Mitigating Risk - Surgical
Care Improvement Project
(SCIP) – An Evidence-Based
Approach
•
•
•
•
Timely and appropriate
antimicrobial prophylaxis
Glycemic control in cardiac
and vascular surgery
Appropriate hair removal
Normothermia in general
surgical patients
Is this the Holy Grail?
An Increase in Compliance With the Surgical Care
Improvement Project Measures Does Not Prevent Surgical
Site Infection in Colorectal Surgery
Pastor et al. Diseases of the Colon & Rectum 2010; 53:24-30
“The report by Stulberg et al in this
issue of JAMA is the largest study to
date that fails to demonstrate an
association between adherence to
SCIP process measures and the
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
substantial improvements in SCIP
adherence over the 2-year study
period, postoperative infection rates
actually increased.”
MT Hawn – Editorial JAMA
Does the Process Improve the Outcome?
The author’s analysis suggest that,
“…there was little or no association
between compliance with most
SCIP infection-related process
measures and ACS NSQIP riskadjusted outcome…….with the
exception of administration of the
appropriate antibiotic (SCIP-2).”
Ingraham et al. J Am Coll Surg 2010;211:705-711
Taking a SCIP-Plus Perspective to
Risk Reduction
Does increase BMI warrant a
change in how we dose
(prophylactic) our patients?
“Measured and dose-normalized
subcutaneous cefoxitin concentrations
and AUCs in the obese patients were
significantly lower than in the normalweight 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.”
Toma et al., Anesthetic Pharmacology and Preclinical Pharmacology 2011;113:730-737
Perioperative Antimicrobial Prophylaxis in
Higher BMI (>30) Patients: Do We Achieve
Therapeutic Levels?
Percent Therapeutic Activity of Serum/Tissue Concentrations Compared to
Surgical Isolate Susceptibility (2002-2004/2006-2009) to Cefazolin Following 2
gm (N = 38) and 3 gm (N = 40) Perioperative Dosing Regimen
2-gma
3-gmb
Organism
N
Serum
Tissue
N
Serum
Tissue
S. aureus
70
68.6%
27.1%
92
87.5%
68.5%
S. epidermidis
110
34.5%
10.9%
156
64.5%
49.6%
E. coli
85
75.3%
56.4%
101
92.4%
86.5%
Kl. pneumoniae
55
80%
65.4%
49
96.8%
98.4%
a
period covering 2001-2003
b
period covering 2006-2009
aEdmiston
et al, Surgery 2004;136:738-747
bEdmiston et al., In Press 2011: Surgical Infection
Effect of Maternal Obesity on Tissue Concentration
Of Prophylactic Cefazolin During Cesarean Delivery
Pevzner L, Edmiston CE, et al. Obstet & Gynecol 2011;117:877-882
Percent (%)
Perioperative Cefazolin Prophylaxis
During Cardiovascular Surgery: Are
Therapeutic Levels Impacted by BMI?*
N = 10/Group
*% therapeutic level versus BMI and cefazolin breakpoint
Surgical Microbiology Research Laboratory 2011
Best Practice # 1: All surgical
patients will receive a minimum dose
of 2 gram unless their BMI is >30 –
Then the correct dose is 3 grams
Please Note: All surgical procedures
at Froedtert Hospital are viewed as
SCIP-eligible procedures
Risk Reduction Begins on the Front-End
Quantitative Microbial Recovery from the Skin Surface*
•
Scalp
6.0 Log10 cfu/cm2
•
Axilla
5.5 Log10 cfu/cm2
•
Abdomen
4.3 Log10 cfu/cm2
•
Forearm
4.0 Log10 cfu/cm2
•
Hands
4.0-6.6 Log10 cfu/cm2
•
Perineum
7.0-11.0 Log10 cfu/cm2
*Surgical Microbiology Research Laboratory 2010 – Medical College of Wisconsin, Department of Surgery
Mean Chlorhexidine Gluconate (CHG) Skin Surface
Concentrations (µg/ml+SD) Compared to MIC90 (5 µg/ml)
for Staphylococcal Surgical Isolates Including MRSAa
Subgroups (mean C, µg/ml)
Groups
a
Pilotb
1
2
(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)
126.4+19.4
1745.5+204.3
2.5
25.3
349.1
<0.0001
9.9+7.1
N = 90
b Pilot group N = 30
Edmiston et al, J Am Coll Surg 2008;207:233-239
Edmiston et al, AORNJ 2010;92:509-518
Preadmission Showering/Cleansing Skin
Preparations as a Pathway
to Improving Patient Outcomes (Evidence-Based)
•
Reducing the risk of SSI in orthopaedic surgery
•
•
Standardized precleansing initiative (CHG cloths) in total joint patients (night
before/morning of surgery)
50% overall reduction in SSI
Eiselt - Orthopaedic Nursing 2009;28:141-145
•
Bundling risk reduction strategies – Quality initiative
•
•
•
MRSA prescreening in orthopaedic, obstetric, bariatric patients – decolonization
+ precleansing with 2% CHG
>60% overall reduction in SSI
>75% reduction in MRSA SSI
Lipke VL Hyott AS. AORNJ 2010’;62:288-296
• Eradication of MRSA in orthopaedic patients
•
•
60% reduction in MRSA infections
40% reduction in MSSA infection
Kim et al. J Bone Joint Surg 2010;92;1820-1826
Best Practice # 2: All patients
undergoing an elective surgical procedure
will take a minimum of 2 CHG antiseptic
shower/cleansings using a standardized
regimen – The CHG must be supplied to
the patient by the hospital
Why Should We Consider Chlorhexidine
Gluconate (CHG)?
•
Persistent antimicrobial activity for up to 6 hours 1, 5
•
Documented residual activity and repeat applications will maximize
antimicrobial effect 2, 5
•
Rapid bactericidal action 3, 5
•
Has good to excellent activity against gram-positive and gramnegative bacteria 4, 5
•
CHG activity is not adversely impacted by either blood or tissue
proteins 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. 4th
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
Control Practices Advisory Committee, Atlanta GA.; 5. Edmiston CE et al. Am J Infection Control
2007;35:89.
DESIGN:
Multi Center:
A PROSPECTIVE, RANDOMIZED, MULTICENTER
CLINICAL TRIAL OF 2% CHLORHEXIDINE GLUCONATE /
70% ISOPROPYL ALCOHOL (Alc-CHG) VS POVIDONEIODINE (PI) FOR PREVENTION OF SSI
Michael E. Debakey Veterans Affairs Medical Center, Ben Taub General
Hospital, Houston, Veterans Affairs Medical Center, Boston, Medical College of
Wisconsin, Milwaukee, Veterans Affairs Medical Center, Atlanta, Baylor College
of 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 vs
8.6% 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-contaminated
procedures
New England Journal of Medicine 2010;362:18-26
Best Practice # 3:
Alcohol/chlorhexidine gluconate
represents the state-of-the-art skin
antiseptic agent
Please Note: Froedtert services using Alcohol/CHG for
skin antisepsis: general, vascular, CT, orthopaedic,
urology, neurosurgery, OB/GYN, hepatobiliary, solid
organ transplant
Utilizing Innovative Impregnated Technology to Reduce the
Risk of Surgical Site Infections
J Am Coll Surg 2006;203:481-489
Mean Microbial Recovery from Standard
Polyglactin 910 Sutures (V) and TriclosanCoated Polyglactin 910 Braided Sutures (VT)
Mean colony forming units
(cfu)/cm suture
300
275
V
250
VT
225
200
N=10
175
150
125
p<0.01
100
75
50
25
0
102
105
S. aureus
(MRSA)
102
105
S. epidermidis
RP62A
102
105
E. coli
Exposure Time 2 Minutes
Edmiston et al, J Am Coll Surg 2006;203:481-489
Braided
Monofilament
Zones of Inhibition - S. aureus (MRSA)
Edmiston et al., J Am Coll Surg 2006;203;481-489; 2011
Mechanistic Benefits of Antimicrobial Sutures
• Reduce risk of wound contamination
• Reduction in device contamination
• Elution of antiseptic agent within the wound bed
Are Sutures Really a Nidus for Infection?
Staphylococcus epidermidis Incisional Wound Infection
Surgical Microbiology Research Laboratory, Milwaukee - 2005
Percent Sutures Recovered from Infected Cases and
Mean Microbial Recovery from Explanted
Absorbable / Non-Absorbable Devices*
Percent Infected Cases
Polydioxanone (fascia,
n=18)
Poliglecaprone (skin, fascia,
n=13)
Polyglactin (fascia,
n=14)
Polypropylene (fascia,
n=37)
38.5%
Nylon (fascia, n=11)
36.4%
Nylon (skin,
n=65)
Microbial Recovery (log 10 cfu/cm suture)
5/18
27.7%
5/13
28.5%
4/14
59.5%
9.2% 6/65
6.3
5.9
6.9
22/37
4/11
5.1
5.6
4.9
5
*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
Presence of Biofilm on Selected Sutures from
Non-Infected and Infected Cases
100 100
100 100
Presence of Biofilm (%)
SUTURES
Nylon a
Braided b
Monofilament c
62.5
Non-Infected Cases
(Nylon = 16) a
a16
Infected Cases
Superficial SSI Deep Incisional SSI
(N = 8)
(N = 8)
non-infected nylon suture segments were randomly selected for microscopy
infected braided suture segments were randomly selected for microscopy
c12 infected monofilament suture segments were randomly selected for microscopy
b4
Making an Evidence-Based Argument for
Antimicrobial (Triclosan) Coated Sutures
Safety
1. Ford et al. Intraoperative handling and wound healing…… Surg Infect 2005;3:313
Clinical Efficacy
2. Edmiston et al. Bacterial adherence to surgical sutures:…Surgery 2006;203:481.
3. Rozzelle at al. Antimicrobial sutures for wound closure in CSF shunt surgery…… J
Neurosurg 2008;42:111
4. Pico et al. Incisional closure following appendectomy in children….Pediatric Surg
2008;21:199
5. Justinger et al. Antimicrobial coating of abdominal closure sutures and infection…..
Surgery 2009;145:330
6. Mingmalairak et al. Efficacy of antimicrobial coated sutures in reducing SSI following
appendectomy. J Med Assoc Thai 2009;92:770
7. Chao-ping et al. Comparison of two absorbable sutures for abdominal wall closure. J Clin
Rehab Tissue Eng Research 2009;13:4045
8. Galal et al. Impact of using triclosan-antibacterial sutures on incidence of surgical site
infection. Am J Surgery 2011;202:133-138
Economic Benefit
9. Fleck et al. Triclosan-coated sutures for reduction of sternal wound infection….Ann Thor
Surg 2007;84:232
10. Stone et al. Healthcare saving associated with reduced infection in CSF shunt
procedures….Pediatric Neurosurg 2009;46:19-24
Antimicrobial Suture Technology – Emerging
Evidence of Clinical Efficacy
•
An Accumulation of Evidence-Base Outcome Data
16 Published clinical studies (12 independent investigator initiated)
• 9 RCTs (Randomized Controlled Trials)
• 6 NRCTs (Non-Randomized Controlled Trials)
• 1 Economic Evaluation of a Trial Previously Reported (Stone et
al)
• 10 + studies in progress
• Independent initiated as well as industry funded
• Including robust hypothesis-testing RCTs
• Multiple specialties (CV, GS, Ortho, Breast)
• Multiple international venues
Meta-Analysis – Random Effects Model
- p = 0.0012
“Although use of antimicrobial sutures is not a
routine practice, the benefits are becoming
increasingly apparent. Recent evidence-based
clinical studies have demonstrated both the clinical
and economic benefit of this technology.” APIC
2010 Orthopaedic Risk Reduction Guidelines –
However, it should never be viewed as a “Magic
Bullet” but rather a component of a thoughtful,
evidence-based risk reduction stratgey
 A Special Consideration: DeviceRelated Breast Infections – Building
an Evidence-Based Intervention
Considering the Risk and Microbial
Epidemiology of Breast Infections: NonDevice versus Device-Related
• Operative closure and SSI in women undergoing breast conserving therapy
(N=580) -11.7% (superficial) vs. 5.2% (full-thickness)
Indelicato et al, Surgery 2007;141:645
• Economic burden N=949): mastectomy with immediate reconstruction
(implant) – 12.4% vs. mastectomy only – 4.4% vs. breast reduction – 1.1% Suboptimal antimicrobial prophylaxis modifiable risk factor
Olsen et al, J Am Coll Surg 2008;207:326
• Breast augmentation (N=3,002) – 1.1% (<1.0%-2.5%): modifiable risk factor –
drains
Araco et al, Aesthetic Plastic Surgery 2007;31:325
Considering the Risk and Microbial
Epidemiology of Breast Infections
Microbial Etiology
Percent
•
Methicillin-sensitive Staphylococcus aureus
41.9 (35)a
•
Methicillin-resistant Staphylococcus aureus
16.3 (22)
•
Coagulase-negative staphylococci
7.0 (11)
•
Streptococcal sp.
4.7 (<2.0)
•
Gram-negative
8.0 (<6.0)
•
Pseudomonas aeruginosa
18.6 (<7.0)
•
Polymicrobial
16.3 (<12)
•
No growth
aMCW
9.3 (<6.0)
implant experience (2000-2009)
Olsen et al, J Am Coll Surgery 2008;207:326
“Is 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 Wisconsin
Building an Evidence-Based Risk
Reduction Strategy for Breast
Reconstruction – A 6 Point Strategy
•
•
•
•
•
•
CHG shower or cleansing - EB
Augment antibiotic dosing – 2 to 3 grams - EB
Alc/CHG perioperative antisepsis – EB
Antimicrobial (CHG) dressing post JP insertion - TBD
CHG irrigation (0.05%) - TBD
Antimicrobial closure technology - EB
Improving Patient Outcome Requires One
To “Think Different”
The Mechanistic Etiology of a Surgical
Site Infection – Let Me Count the Ways
•
•
The patient’s own endogenous flora – skin antisepsis
Intrinsic versus extrinsic considerations
- Inadequate sterilization/disinfection
- Breaks in sterile technique
- Nasopharyngeal shedding
- Microperforation of surgical gloves
Looking at the Risk of Surgical Site Infections
from a New Mechanistic Perspective
Surgical Glove Perforation and the Risk of Surgical Site
Infection – Analysis of 4147 Surgical Cases
•
Compared to a control group logistic regression model documented a higher
likelihood of SSI in procedures in which surgical gloves were perforated and
errors had occurred in antimicrobial prophylaxis (adjusted OR, 4.2; 95% CI,
1.7-10.8; P=0.003).
Misteli et al. Arch Surgery 2009;144:553-558
Bacteria Passage Following Surgical Glove Perforation
•
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
surgical wound.
Harmob et al. Am J Infect Control 2010;38:154-158
Integrated Antimicrobial Surgical Glove Technology
Outer mechanical layer
Middle layer including the
antimicrobial liquid in droplike compartments
Inner mechanical layer
Skin (hand)
Sonntag et al., Nature Materials 2004;3:311-315
Krikorian R, J Hosp Infect 2007;66:339-345
Mean Microbial (S. aureus) Recovery
(cfu/ml) at 10 and 45 Minutes Post
Surgical Glove Microperforation*
cfu/ml
418
351
292
p<0.005
NS
24.5
180
p<0.05
p<0.005
1.4
*N = 24 gloves per group
Daeschlein and Edmiston – Am J Infect Control 2011;39:98-103
Why Should an Antimicrobial Surgical Glove
be Viewed as a Risk Reduction Strategy
Viewing Risk from a Mechanistic Perspective
•
•
•
•
•
Microperforation rates exceed 25% in selective surgical
services
Microbial rebound (hand) occurs in all surgical cases
Perforation rates highest in non-dominant hand (thumb
and index finger)
Wound bed vulnerable to contamination – hyperglycemia
and corticosteroids diminish wound defenses
Biomedical devices at high risk for contamination – 40%
of SSI discovered beyond 30 days
Caveat - Surgical site infections
represent a complex and multifactorial process - the mechanistic
etiology is quite often elusive,
requiring innovative solutions
Era of Surgical Transparency –
NHSN and CMS (308d Participation
and Consent Document)
A New Era of Transparency – A Surgeon’s
Perspective
• 4-year colorectal infection rate = 24.5%
(Surgery 2007;142:704)
• Operative closure and SSI in women
undergoing breast conserving therapy = 5.2
to 11.7% (Surgery 2007;141:645)
• SSI risk factors in inflammatory bowel
patients undergoing colorectal procedures =
>15% (Diseases Colon & Rectum
2007;50:331)
• Post-cesarean surgical site infection rate –
8.9% (post-discharge) vs 1.8% at hospital
discharge (Acta Obstet Gynecol
2007;86:1097)
Thinking outside of the box – impact of BMI, diminished
granulocytic cell function
The Pogo Effect –
“Yep, we have met
the enemy and he
is us”