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Title: Using Traditional and Innovative Risk Reduction Strategies to Reduce the Risk of SSIs in a Transparent and Evidence-Based Healthcare Environment


1
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_at_mcw.edu
2
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3
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
4
  • Risk Reduction Requires an Understanding of the
    Mechanistic Factors which Potentiate the Risk of
    Infection in the Surgical Patient Population

5
Health Care-Associated Infections
2010 National Patient Safety Goals (NPGS) The
Joint Commission
  • 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).

6
Evidence-Based Hierarchy
7
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?
8
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 5324-30
9
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
10
Does the Process Improve the Outcome?
The authors analysis suggest that, there was
little or no association between compliance with
most SCIP infection-related process measures and
ACS NSQIP risk-adjusted outcome.with the
exception of administration of the appropriate
antibiotic (SCIP-2).
  • Ingraham et al. J Am Coll Surg 2010211705-711

11
  • Taking a SCIP-Plus Perspective to Risk Reduction

12
  • Does increase BMI warrant a change in how we dose
    (prophylactic) our patients?

13
Toma et al., Anesthetic Pharmacology and
Preclinical Pharmacology 2011113730-737
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.
14
Perioperative Antimicrobial Prophylaxis in Higher
BMI (gt30) 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 2004136738-747 bEdmisto
n et al., In Press 2011 Surgical Infection
15
Effect of Maternal Obesity on Tissue
Concentration Of Prophylactic Cefazolin During
Cesarean Delivery
Pevzner L, Edmiston CE, et al. Obstet Gynecol
2011117877-882
16
Perioperative Cefazolin Prophylaxis During
Cardiovascular Surgery Are Therapeutic Levels
Impacted by BMI?
Percent ()
N 10/Group
therapeutic level versus BMI and cefazolin
breakpoint
Surgical Microbiology Research Laboratory 2011
17
  • Best Practice 1 All surgical patients will
    receive a minimum dose of 2 gram unless their BMI
    is gt30 Then the correct dose is 3 grams
  • Please Note All surgical procedures at Froedtert
    Hospital are viewed as SCIP-eligible procedures

18
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19
Risk Reduction Begins on the Front-EndQuantitativ
e 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
20
Mean Chlorhexidine Gluconate (CHG) Skin Surface
Concentrations (µg/mlSD) 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) 3.72.5 24.45.9
436.191.2 0.9 4.8 87.2
lt0.001 Group B (20)
morning (1X) 7.85.6 79.226.5
991.358.2 1.9 15.8 198.2
lt0.0001 Group C (20) both (2X) 9.97.1
126.419.4 1745.5204.3 2.5 25.3
349.1 lt0.0001
a N 90
Edmiston et al, J Am Coll Surg 2008207233-239
Edmiston et al, AORNJ 201092509-518
b Pilot group N 30
21
Preadmission Showering/Cleansing Skin
Preparations as a Pathwayto 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 200928141-145
  • Bundling risk reduction strategies Quality
    initiative
  • MRSA prescreening in orthopaedic, obstetric,
    bariatric patients decolonization
    precleansing with 2 CHG
  • gt60 overall reduction in SSI
  • gt75 reduction in MRSA SSI
  • Lipke VL Hyott AS. AORNJ 201062288-296

  • Eradication of MRSA in orthopaedic patients
  • 60 reduction in MRSA infections
  • 40 reduction in MSSA infection
  • Kim et al. J Bone Joint Surg 2010921820-1826

22
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23
  • 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

24
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 gram-negative 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.
    198816(6)253-65 2. Paulson D, Am J Infect
    Control. 199321205-9 3. Denton GW,
    Chlorhexidine. In Seymour S. Block (Ed.)
    Disinfection, sterilization, and preservation.
    4th Ed., Lea Febiger, Williams Wilkins, Media
    PA, 1991279 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 20073589.

25
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26
DESIGN A PROSPECTIVE, RANDOMIZED, MULTICENTER
CLINICAL 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 of Wisconsin,
    Milwaukee, Veterans Affairs Medical Center,
    Atlanta, Baylor College of Medicine, Houston
  • Patients gt 18 years, undergoing
    clean-contaminated procedures (gastrointestinal,
    thoracic, urologic and gynecologic)
  • N 849 surgical patients 409 Alc-CHG vs 440 PI
  • 11 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, p0.004
  • Significant difference for both superficial
    incisional site rate 4.2 A-CHG vs 8.6 PI
    (p0.008) and deep incisional 1 A-CHG vs 3 PI
    (p0.05)
  • 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 201036218-26
27
  • 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

28
Utilizing Innovative Impregnated Technology to
Reduce the Risk of Surgical Site Infections
J Am Coll Surg 2006203481-489
29
Mean Microbial Recovery from Standard Polyglactin
910 Sutures (V) and Triclosan-Coated Polyglactin
910 Braided Sutures (VT)
V VT
N10
Mean colony forming units (cfu)/cm suture
plt0.01
102
105
102
105
102
105
S. aureus (MRSA)
S. epidermidis RP62A
E. coli
Exposure Time 2 Minutes
Edmiston et al, J Am Coll Surg 2006203481-489
30
Braided
Monofilament
Zones of Inhibition - S. aureus (MRSA)
Edmiston et al., J Am Coll Surg
2006203481-489 2011
Mechanistic Benefits of Antimicrobial Sutures
  • Reduce risk of wound contamination
  • Reduction in device contamination
  • Elution of antiseptic agent within the wound bed

31
Are Sutures Really a Nidus for Infection?
Staphylococcus epidermidis Incisional Wound
Infection
Surgical Microbiology Research Laboratory,
Milwaukee - 2005
32
Percent Sutures Recovered from Infected Cases and
Mean Microbial Recovery from Explanted Absorbable
/ Non-Absorbable Devices
Percent Infected Cases
Microbial Recovery (log 10 cfu/cm suture)
Polydioxanone (fascia, n18)
5/18
38.5
6.3
Poliglecaprone (skin, fascia, n13)
5/13
27.7
5.9
Polyglactin (fascia, n14)
4/14
28.5
6.9
Polypropylene (fascia, n37)
22/37
59.5
5.1
4/11
Nylon (fascia, n11)
36.4
5.6
Nylon (skin, n65)
6/65
9.2
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 
33
Presence of Biofilm on Selected Sutures from
Non-Infected and Infected Cases
100
100
100
100
100
100
100
100

SUTURES
Nylon a
Braided b
62.5
62.5
Monofilament c
Presence of Biofilm ()
Non-Infected Cases (Nylon 16) a
Infected Cases Superficial SSI
Deep Incisional SSI (N 8) (N
8)
a16 non-infected nylon suture segments were
randomly selected for microscopy b4 infected
braided suture segments were randomly selected
for microscopy c12 infected monofilament suture
segments were randomly selected for microscopy
34
Making an Evidence-Based Argument for
Antimicrobial (Triclosan) Coated Sutures
  • Safety
  • 1. Ford et al. Intraoperative handling and wound
    healing Surg Infect 20053313
  • Clinical Efficacy
  • 2. Edmiston et al. Bacterial adherence to
    surgical suturesSurgery 2006203481.
  • 3. Rozzelle at al. Antimicrobial sutures for
    wound closure in CSF shunt surgery J Neurosurg
    200842111
  • 4. Pico et al. Incisional closure following
    appendectomy in children.Pediatric Surg
    200821199
  • 5. Justinger et al. Antimicrobial coating of
    abdominal closure sutures and infection..
    Surgery 2009145330
  • 6. Mingmalairak et al. Efficacy of antimicrobial
    coated sutures in reducing SSI following
    appendectomy. J Med Assoc Thai 200992770
  • 7. Chao-ping et al. Comparison of two absorbable
    sutures for abdominal wall closure. J Clin Rehab
    Tissue Eng Research 2009134045
  • 8. Galal et al. Impact of using
    triclosan-antibacterial sutures on incidence of
    surgical site infection. Am J Surgery
    2011202133-138
  • Economic Benefit
  • 9. Fleck et al. Triclosan-coated sutures for
    reduction of sternal wound infection.Ann Thor
    Surg 200784232
  • 10. Stone et al. Healthcare saving associated
    with reduced infection in CSF shunt
    procedures.Pediatric Neurosurg 20094619-24

35
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

36
Meta-Analysis Random Effects Model
- p 0.0012
37
  • 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

38
  • A Special Consideration Device-Related Breast
    Infections Building an Evidence-Based
    Intervention

39
Considering the Risk and Microbial Epidemiology
of Breast Infections Non-Device versus
Device-Related
  • Operative closure and SSI in women undergoing
    breast conserving therapy (N580) -11.7
    (superficial) vs. 5.2 (full-thickness)
  • Indelicato et al, Surgery 2007141645
  • Economic burden N949) 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 2008207326
  • Breast augmentation (N3,002) 1.1
    (lt1.0-2.5) modifiable risk factor drains
  • Araco et al, Aesthetic Plastic Surgery
    200731325

40
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 (lt2.0)
  • Gram-negative 8.0 (lt6.0)
  • Pseudomonas aeruginosa 18.6 (lt7.0)
  • Polymicrobial 16.3 (lt12)
  • No growth 9.3 (lt6.0)
  • aMCW implant experience (2000-2009)
  • Olsen et al, J Am Coll Surgery 2008207326

Is cefazolin sufficient in breast implant
surgery Feldman et al, Plast Reconstr Surg
2010126779
41
Staphylococcal Biofilm - Surgical Microbiology
Research Laboratory 2006 - Medical College of
Wisconsin
42
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

43
The Mechanistic Etiology of a Surgical Site
Infection Let Me Count the Ways
  • The patients own endogenous flora skin
    antisepsis
  • Intrinsic versus extrinsic considerations
  • - Inadequate sterilization/disinfection
  • - Breaks in sterile technique
  • - Nasopharyngeal shedding
  • - Microperforation of surgical gloves

44
Looking at the Risk of Surgical Site Infections
from a New Mechanistic PerspectiveSurgical
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 P0.003).
  • Misteli et al. Arch Surgery 2009144553-558

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 201038154-158
45
Integrated Antimicrobial Surgical
Glove Technology
Outer mechanical layer
Middle layer including the antimicrobial liquid
in drop- like compartments
Inner mechanical layer
Skin (hand)
Sonntag et al., Nature Materials 20043311-315
Krikorian R, J Hosp Infect 200766339-345
46
Mean Microbial (S. aureus) Recovery (cfu/ml) at
10 and 45 Minutes Post Surgical Glove
Microperforation
418
351
cfu/ml
292
plt0.005
NS
24.5
180
plt0.005
plt0.05
1.4
N 24 gloves per group
Daeschlein and Edmiston Am J Infect Control
20113998-103
47
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

48
  • Caveat - Surgical site infections represent a
    complex and multi-factorial process - the
    mechanistic etiology is quite often elusive,
    requiring innovative solutions

49
  • Era of Surgical Transparency NHSN and CMS (308d
    Participation and Consent Document)

50
A New Era of Transparency A Surgeons
Perspective
  • 4-year colorectal infection rate 24.5 (Surgery
    2007142704)
  • Operative closure and SSI in women undergoing
    breast conserving therapy 5.2 to 11.7 (Surgery
    2007141645)
  • SSI risk factors in inflammatory bowel patients
    undergoing colorectal procedures gt15 (Diseases
    Colon Rectum 200750331)
  • Post-cesarean surgical site infection rate 8.9
    (post-discharge) vs 1.8 at hospital discharge
    (Acta Obstet Gynecol 2007861097)

Thinking outside of the box impact of BMI,
diminished granulocytic cell function
51
The Pogo Effect Yep, we have met the enemy and
he is us
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