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New Highlights in Central LineAssociated Bloodstream Infection
and Surgical-Site Infection
Prevention
Rabih O. Darouiche, MD
VA Distinguished Service Professor
Director, Center of Prostheses Infection
at Baylor College of Medicine
Safe Practices Webinar
February 18, 2010
23
Disclosure Statement
• Co-invented antimicrobial-coated catheters that are
licensed by Baylor College of Medicine to Cook Inc
• Received educational and research grants from CareFusion
• Do not plan to discuss off-label and investigational use of
devices or drugs
24
Overview of Presentation
• Address similarities and differences between
CLABSI and SSI
• Assess the impact of these two infections
• Analyze potentially protective approaches
25
Similarities Between CLABSI and SSI
• Both infections result primarily from breaking
skin integrity
• Both infections are caused mostly by skin
organisms
• Both infections occur at unacceptably high rates,
can be difficult to manage, may require future
intervention(s), and are expensive to treat
26
Differences Between CLABSI and SSI
• CLABSI manifests while the catheter is still in
place, whereas SSI can manifest at any time after
surgery, usually by 30 days post-op
• Microbiologic cause of CLABSI is almost always
identified, whereas the microbiologic cause of
SSI is unknown in many patients
• Occurrence of CLABSI can be attributed to
various healthcare providers, whereas SSI is
typically linked to the surgeon
27
Clinical Manifestations of infected CVC
• Exit site infection
• Tunnel infection
• Thrombophlebitis
• BSI
Impact of CLABSI
• Incidence: of the 6 million CVC inserted
annually in the U.S., 250,000 result in BSI
• Management: cure often requires removal of
the infected catheter and long antibiotic
therapy
• Medical sequelae: attributable mortality 5%25%
• Economic burden: cost of treatment is $10K$56K; annual cost in U.S., $3 billion–$16.8
billion
29
Annual Death Rates in the U.S.
for Selected Infectious Diseases
30,000
25,000
Deaths per Year
20,000
15,000
10,000
5,000
0
CRBSI
MRSA
AIDS
Hep B
Tbc
Measles
Nosocomial Infections in the ICU
95% Urinary Catheters
86% Mechanical Ventilation
UTI
31%
PNEU
27%
87% central lines
< 55 = 33%
55 – 70 = 32%
>70 = 35%
BSI
19%
GI
5%
CVS
4%
EENT
4%
LRI
4%
National Nosocomial Infections Surveillance (NNIS) (97 hospitals)
OTHER
6%
N= 14,177
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Gram-Positive Bacteremia in Cancer Patients:
Role of the CVC
% of Bacteremia with
CVC as the source
80%
70%
70%
56%
60%
50%
40%
44%
30%
30%
20%
10%
0%
Non-CRBSI
CRBSI
Solid Tumor Malignancy
Non-CRBSI CRBSI
Hematologic Malignancy
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Difference between Surveillance Definition
(by National Healthcare Safety Network: NHSN)
and Clinical/Microbiologic Definition of CLABSI
• Surveillance definition: includes all cases of BSI
in patients with CVC in whom other sites of
infection are excluded (catheter-associated BSI
varies from from 1.3/1000 cath-days in medical
surgical wards to 5.6/1000 cath-days in burn
ICU)
• Clinical/microbiologic definition: includes only
cases of BSI in patients with CVC in whom
other sites of infection are excluded and
microbiologic relationship of catheter to BSI
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exists (catheter-related BSI)
Relationship between Catheter
Colonization and Bloodstream Infection
• Principle: catheter colonization is a prelude to
catheter-related bloodstream infection
• Objective: to prevent infection by inhibiting
catheter colonization
34
IA Recommendations in Upcoming CDC
Guidelines for Prevention of CLABSI
•
•
•
•
•
•
Staff education and training
Insert CVC in subclavian catheters
Place hemodialysis catheters in jugular or femoral veins
Promptly remove CVC when no longer essential
Hand wash with soap/water or alcohol-based hand rubs
Utilize 2% chlorhexidine-based preparation for skin
cleansing before inserting CVC, during dressing changes,
and wiping access ports of needleless catheter systems
• Use sterile gauze or transparent semi-permeable dressings
• Use antimicrobial-impregnated CVC if expected duration
of placement >5 days and CLABSI remains higher than
goal set by institutions despite comprehensive strategy
Guidelines for the Prevention of Intravascular Catheter-related Infections.
Atlanta (GA): Centers for Disease Control and Prevention; 2010. [draft]
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NQF CLABSI Prevention Safe Practice
Specifications: 2010 Update
Before insertion:
• Educate healthcare personnel involved in the insertion, care, and
maintenance of central venous catheters (CVCs).
At insertion:
•
•
•
•
•
•
Use a catheter checklist at the time of CVC insertion.
Perform hand hygiene prior to catheter insertion or manipulation.
Avoid using the femoral vein for central venous access in adult patients.
Use a catheter cart or kit with components for aseptic catheter insertion.
Use maximal sterile barrier precautions.
Use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin
antiseptic preparation in patients over two months of age and allow
appropriate drying time per product guidelines.
After insertion:
• Use a standardized protocol to disinfect catheter hubs, needleless
connectors, and injection ports before accessing the ports.
• Remove nonessential catheters.
• Use a standardized protocol for non-tunneled CVCs in adults and
adolescents for dressing care.
• Perform surveillance for CLABSI and report the data on a regular basis.
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Comprehensive Protective Strategy
Infection Control Bundle
• Hand washing
• Maximal barrier precautions
• 2% chlorhexidine-based skin antisepsis
• Avoiding femoral site if possible
• Removing unnecessary catheters
37
Potential Limitations of Traditional
Infection Control Measures
Although very essential, they:
• Are not easily enforceable
• Are not very durable
• Do not completely prevent
infection
• Save some, but not
enough, lives
Reasons to Optimize Prevention of SSI
• Unacceptably high incidence: the 30 million
annual surgical procedures in the U.S. result in
300,000-500,000 cases of SSI
• Difficult management: may require repeated
surgical interventions
• Serious medical consequences: tremendous
morbidity and occasional mortality
• Soaring economic burden: annual cost of
treatment in the U.S. is >$7 billion
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Perioperative Approaches
for Preventing SSI
• Non-antimicrobial approaches
• Normothermia
• Adequate oxygenation
• Tight glucose control
• Antimicrobial approaches
• Systemic antibiotic prophylaxis
• Nasal application of mupirocin
• Skin antisepsis
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Impact of Timing of Systemic Antibiotic Prophylaxis on SSI
41
A Prospective Randomized Trial of Nasal
Mupirocin Plus Chlorhexidine Wash
Rapid identification of nasal carriage by S. aureus
followed by a 5-day course of nasal mupirocin plus
chlorhexidine wash:
• Reduces S. aureus infection (3.4% vs. 7.7%)
• Decreases S. aureus SSI by almost 60%
Bode, et al. N Engl J Med 2010;362:9-17
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Importance of the Skin
• Largest bodily organ
• Protective barrier
• Skin flora most
common cause of SSI
(and CLABSI)
• 80% of bacteria reside
in epidermis
Factors that Support the Need for
Optimal Skin Antisepsis
• Most pathogens that cause SSI are skin flora
• At least 2/3 of cases of SSI are incisional
• Most SSI are considered preventable
• Other preventive measures reduce but do not
eliminate SSI
44
Commonly used Preoperative
Antiseptics
• Povidone-iodine (Iodophor)
• Chlorhexidine gluconate
• Alcohol
• Combination products: >2 active agents
45
Comparison of Antimicrobial
Activity of Antiseptic Preparations
Chlorhexidine-based preparations are better
than alcohol or iodine-based products in:
• Reducing colonization of vascular catheters
• Preventing contamination of blood cultures
• Decreasing contamination of surgical tissues
46
Pressing Need to Compare Clinical Efficacy
of Antiseptic Preparations in Preventing SSI
• CDC guidelines for prevention of infections
related to vascular catheters recommend
antiseptic cleansing of the skin with 2%
chlorhexidine-containing products
O’Grady, et al. Centers for Disease Control and
Prevention. MMWR Morb Mortal Wkly Rep
2002;51(RR-10):1-29
• CDC has not previously issued a preference as
to type of preoperative skin antiseptics
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Prospective, Randomized, 6-Center Clinical
Trial of 849 Patients
• Population: adult patients scheduled for abdominal or
non-abdominal clean-contaminated surgery
• Randomization: hospital-stratified
• Intervention: preoperative skin cleansing with:
• ChloraPrep® (2% chlorhexidine gluconate-70%
isopropyl alcohol = CA) 26-ml applicators; OR
• 10% povidone-iodine (PI) scrub and paint
• Evaluation: SSI was assessed by blinded evaluators
Darouiche, et al. N Engl J Med 2010;362:18-26
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Proportion of Patients with Surgical-Site Infection, According to Type of
Infection (Intention-to-Treat Population).
ChlorhexidineAlcohol
(N=409)
no. (%)
PovidoneIodine
(N=440)
no. (%)
Any surgical-site infection
39 (9.5)
71 (16.1)
0.59
(0.41-0.85)
0.004
Superficial incisional
infection
17 (4.2)
38 (8.6)
0.48
(0.28-0.84)
0.008
Deep incisional infection
4 (1.0)
13 (3.0)
0.33
(0.11-1.01)
0.05
Organ-space infection
18 (4.4)
20 (4.6)
0.97
(0.52-1.80)
>0.99
Sepsis from surgical-site
infection
11 (2.7)
19 (4.3)
0.62
(0.30-1.29)
0.26
Type of Infection
Relative Risk
(95% CI)
P-Value
49
Kaplan-Meier Curves for Freedom from Surgical-Site Infection
(Intention-to-Treat Population)
Proportion of Patients with Surgical-Site Infection, According to
Type of Surgery (Intention-to-Treat Population).
Chlorhexidine-Alcohol
N
no.
Infected
(%)
Infected
Abdominal
297
37
Colorectal
186
Biliary
Povidone-Iodine
N
no.
Infected
(%)
Infected
(12.5)
308
63
(20.5)
28
(15.1)
191
42
(22.0)
44
2
(4.6)
54
5
(9.3)
Small intestinal
41
4
(9.8)
34
10
(29.4)
Gastroesophageal
26
3
(11.5)
29
6
(20.7)
112
2
(1.8)
132
8
(6.1)
Thoracic
44
2
(4.5)
57
4
(7.0)
Gynecologic
42
0
(0.0)
40
1
(2.5)
Urologic
26
0
(0.0)
35
3
(8.6)
Type of Surgery
Non-abdominal
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Chlorhexidine-Alcohol (CA) vs. PovidoneIodine (PI) for Prevention of SSI
• CA significantly reduces SSI
• Number of patients needed to receive CA
instead of PI to prevent one case of SSI: 17
• Delays onset of SSI
• CA and PI have similar rates of adverse events
(including events related to study medication in
0.7% in each group) and serious adverse events
52
New CMS Regulations (effective 10/08)
Changes to Inpatient Prospective Payment System
10 non-reimbursable conditions met these criteria:
• High cost
• High volume
• Triggers a high-paying MS-DRG
• May be considered reasonably preventable
through application of evidence-based
guidelines
Federal Register, Volume 73, No. 161; 08/19/08
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Non-reimbursable Infectious Conditions
• Catheter-associated urinary tract infection
• Vascular catheter-associated infection
• Surgical-site infection-mediastinitis after CABG
• Surgery on various joints, including shoulder,
elbow, and spine
54
Perspective
Optimal prevention of CLABSI and SSI can:
• Improve patient care
• Incur cost-savings
• Enhance infection control measures
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