1. New Highlights in Central Line- Associated 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

2. 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 1

3. Overview of Presentation
Address similarities and differences between CLABSI and SSI
Assess the impact of these two infections
Analyze potentially protective approaches

4. 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

5. 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

6. Clinical Manifestations of infected CVC
Exit site infection
Tunnel infection
Thrombophlebitis
BSI

7. 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

8. Annual Death Rates in the U.S. for Selected Infectious Diseases8

9. Nosocomial Infections in the ICU
95% Urinary Catheters
86% Mechanical Ventilation
87% central lines
< 55 = 33%
55 – 70 = 32%
>70 = 35%
N= 14,177
National Nosocomial Infections Surveillance (NNIS) (97 hospitals)

10. Gram-Positive Bacteremia in Cancer Patients: Role of the CVC
80%
70%
70%
56%
60%
50%
44%
% of Bacteremia with CVC as the source
40%
30%
30%
20%
10% 0%
Non-CRBSI
CRBSI
Non-CRBSI
CRBSI
Solid Tumor Malignancy
Hematologic Malignancy

11. 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)

12. 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

13. 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; [draft]

14. 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.

15. Comprehensive Protective Strategy Infection Control Bundle
Hand washing
Maximal barrier precautions
2% chlorhexidine-based skin antisepsis
Avoiding femoral site if possible
Removing unnecessary catheters

16. 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

17. Reasons to Optimize Prevention of SSI
Unacceptably high incidence: the 30 million annual surgical procedures in the U.S. result in 300, ,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 17

18. 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 18

19. Impact of Timing of Systemic Antibiotic Prophylaxis on SSI

20. Bode, et al. N Engl J Med 2010;362:9-17
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
Halle-Mai-2001 20

21. Importance of the Skin Largest bodily organ Protective barrier
Skin flora most common cause of SSI (and CLABSI)
80% of bacteria reside in epidermis 21 21

22. 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

23. Commonly used Preoperative Antiseptics
Povidone-iodine (Iodophor)
Chlorhexidine gluconate
Alcohol
Combination products: >2 active agents 23 23

24. 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

25. 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

26. 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

27. Chlorhexidine-Alcohol
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)
Relative Risk
(95% CI)
P-Value
Any surgical-site infection
39 (9.5)
71 (16.1)
0.59
( )
0.004
Superficial incisional infection
17 (4.2)
38 (8.6)
0.48
( )
0.008
Deep incisional infection
4 (1.0)
13 (3.0)
0.33
( )
0.05
Organ-space infection
18 (4.4)
20 (4.6)
0.97
( )
>0.99
Sepsis from surgical-site infection
11 (2.7)
19 (4.3)
0.62
( )
0.26

28. Kaplan-Meier Curves for Freedom from Surgical-Site Infection (Intention-to-Treat Population)

29. Chlorhexidine-Alcohol
Proportion of Patients with Surgical-Site Infection, According to Type of Surgery (Intention-to-Treat Population).
Chlorhexidine-Alcohol
Povidone-Iodine
Type of Surgery N
no. Infected
(%) 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)
Gastroesophageal 26 3
(11.5) 29 6
(20.7)
Non-abdominal
112
(1.8)
132 8
(6.1)
Thoracic
(4.5) 57
(7.0)
Gynecologic
(0.0) 40 1
(2.5)
Urologic 35
(8.6)

30. Chlorhexidine-Alcohol (CA) vs
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

31. Federal Register, Volume 73, No. 161; 08/19/08
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 31 31

32. 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 32 32

33. Perspective Optimal prevention of CLABSI and SSI can:
Improve patient care
Incur cost-savings
Enhance infection control measures 33