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New Highlights in Central Line-

Associated Bloodstream Infection

and Surgical-Site Infection Prevention

Rabih O. Darouiche, MDVA Distinguished Service Professor

Director, Center of Prostheses Infectionat Baylor College of Medicine

Safe Practices WebinarFebruary 18, 2010

• 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

Disclosure Statement

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• Address similarities and differences between CLABSI and SSI

• Assess the impact of these two infections

• Analyze potentially protective approaches

Overview of Presentation

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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

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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

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Clinical Manifestations of infected CVC

• Exit site infection

• Tunnel infection• Thrombophlebiti

s• 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

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Annual Death Rates in the U.S. for Selected Infectious Diseases

Nosocomial Infections in the ICU

PNEU27%

OTHER6%LRI

4%EENT

4%CVS4%

GI5%

BSI19%

UTI31%

National Nosocomial Infections Surveillance (NNIS) (97 hospitals)

87% central lines

86% Mechanical Ventilation95% Urinary Catheters

N= 14,177

< 55 = 33%55 – 70 = 32%>70 = 35%

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30%

70%

44%

56%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Non-CRBSI CRBSI Non-CRBSI CRBSI

Solid Tumor Malignancy Hematologic Malignancy

% o

f B

acte

rem

ia w

ith

C

VC

as

the

sou

rce

Gram-Positive Bacteremia in Cancer Patients: Role of the CVC

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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 exists (catheter-related BSI)

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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

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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 strategyGuidelines for the Prevention of Intravascular Catheter-related Infections. Atlanta (GA): Centers for Disease Control and Prevention; 2010. [draft]

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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.

NQF CLABSI Prevention Safe Practice Specifications: 2010

Update

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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

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Although very essential, they: • Are not easily enforceable• Are not very durable• Do not completely prevent

infection• Save some, but not

enough, lives

Potential Limitations of Traditional Infection Control

Measures

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 antisepsis40

Impact of Timing of Systemic Antibiotic Prophylaxis on SSI

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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

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Commonly used Preoperative Antiseptics

• Povidone-iodine (Iodophor)• Chlorhexidine gluconate• Alcohol • Combination products: >2 active

agents

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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

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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;362:18-2648

Proportion of Patients with Surgical-Site Infection, According to Type of Infection (Intention-to-Treat Population).

Type of Infection

Chlorhexidine-Alcohol (N=409)no. (%)

Povidone- Iodine

(N=440)no. (%)

Relative Risk(95% CI) P-Value

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

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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 Povidone-Iodine

Type of Surgery Nno.

Infected

(%) Infected N

no. Infected

(%) Infected

Abdominal 297 37 (12.5) 308 63 (20.5)

Colorectal 186 28 (15.1) 191 42 (22.0)

Biliary 44 2 (4.6) 54 5 (9.3)

Small intestinal 41 4 (9.8) 34 10 (29.4)

Gastroesophageal26 3 (11.5) 29 6 (20.7)

Non-abdominal 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)51

Chlorhexidine-Alcohol (CA) vs. Povidone-Iodine (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

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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

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Perspective

Optimal prevention of CLABSI and SSI can:

• Improve patient care• Incur cost-savings• Enhance infection control measures

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