BSI: Addressing Clinical Challenges with Catheter Maintenance · 13. Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related

3M Health Care AcademySM

BSI: Addressing Clinical Challenges with Catheter Maintenance

March 15, 2018

Marc J. Molitor, MSN. RN. VA-BC, CIC


© 3M 2016. All Rights Reserved 2

Disclosure

• Marc J. Molitor, MSN, RN, VA-BC, CIC

o Employed by 3M as a Clinical Specialist

• Presentation will mention brands as this is how it was presented in the literature




Learning Objectives

1. Identify sources of contamination that can lead to

bloodstream infection (BSI)

2. Describe recommended practices and evidence based

interventions for catheter maintenance to reduce BSI risk

3. Discuss clinical challenges associated with catheter

maintenance that can impact outcomes

4. Identify solutions to address these challenges and clinical

studies that support these solutions



Vascular Access and Bloodstream Infection (BSI)

• Intravascular device

• Type of and intended use for the catheter

• Insertion site

• Frequency with which the catheter is accessed, and/or

• Duration of catheter placement

Risk of BSIs vary and may be due to intrinsic or extrinsic factors:2-6

• Experience and education of the individual who inserts the catheter, and/or

• Use of proven preventative strategies

• Characteristics of the catheterized patient:

▪ Patient age

▪ Severity of underlying illness

▪ Patient nutrition

▪ Poor skin integrity, and

▪ Immunocompromised

Catheter-related Operator-related Patient-related

of all hospital acquired bloodstream infections (BSIs) originate from some form of vascular access160%



Terminology

Central Line Associated Bloodstream Infection (CLABSI)

Bloodstream Infection (BSI)

Catheter Related Bloodstream Infection (CRBSI)



CLABSIImprovements made: CLABSI decreased by 58% in hospital ICUs since 20017

23%(18,000)

30%(23,000)

47%(37,000)

Number of CLABSIs

ICU Patients Other Acute Hospital Areas Outpatient Dialysis

78,000 bloodstream infections affect central line patients each year (2009)7

National Patient Safety

Goals

Improve patient safety

Goal 7

Reduce risk of HAIs

07.04.01

Evidence-based practice

to prevent CLABSI

An estimated 65-70% of CLABSIs are preventable8



Patient ImpactHAIs account for a large proportion of the harm to patients caused by health care9

CRBSIs are significant contributors to

preventable hospital deaths.2

Incidence rate estimated for hospitalized adult populations at risk for CLABSI.

1 in 4Patients who

contract CLABSI die7

1.57 times higher risk of mortality in critically ill adults10

1.27 cases per 1000 device-days9

Real world evidence has demonstrated an increase in hospital resources - and associated cost - required to treat morbidities due to CRBSIs11-15

12-24 more hospitalization days



Cost per CLABSI for adult inpatients

Cost to Treat CLABSI is the most costly HAI on a per-case basis9

CLABSI annual cost to US healthcare system

$1.85 billion10.4

6.9

0 2 4 6 8 10 12

Total LOS

ICU days

CLABSI LENGTH OF STAY9

Days

$45,814



The majority of CR-BSIs emanate from either the insertion site or the hub16-19

Organisms on the skin gain access to the bloodstream via migration along the external surface of the catheter

or catheter hub; both important routes of catheter-related bloodstream infections17-21

Whereas the intraluminal route (primarily the hub) predominates after a more extended dwell time24-25

Soon after insertion, the extraluminal route or insertion site is the predominate source of infection17,22-23



The use of bundlesEvidence-based recommendations and performance improvement initiatives or

strategies are bundled together to improve compliance26

Central Line Insertion Bundles26-29

Hand Hygiene

Skin antisepsis using >0.5% chlorhexidine in alcohol solution

Maximal sterile barrier precautions (Mask, cap, sterile gown, large sterile drape and sterile gloves)

Avoid the femoral vein for CVC placement

✔

✔

✔

✔



Maintenance includes many interventions

✔✔

✔

✔

✔

Maintenance Bundles26-29

Assess need for catheter daily

Perform hand hygiene before manipulation of IV system

Dressing change recommendations and guidelines based on dressing type

IV tubing administration set, secondary set and add-on device change guidelines based on medication or product infused

Disinfect IV access ports with appropriate disinfectant for a period of time

After catheter insertion, maintenance bundles have been proposed to ensure optimal catheter care29



ALL vascular access devices = BSI risk

Peripherally inserted central catheter (PICC)

Arterial line catheter (ART)

Central venous catheters (CVC):Internal jugular,

subclavian, femoral

Peripherally inserted catheter

(PIV)



References1. Scheithauer S, Lewalter K, Schröder J, Koch A, Häfner H, Krizanovic V, Nowicki K, Hilgers RD, Lemmen SW. Reduction of central venous line-associated bloodstream infection rates by using a

chlorhexidine-containing dressing. Infection. 2014; 42(1): 155-159.

2. Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc.

2006; 81(9): 1159-1171.

3. O'Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter–related infections. Clin Infect Dis. 2002; 35(11): 1281-1307.

4. Safdar N, Mermel LA, Maki DG. The epidemiology of catheter-related infection in the critically ill. In: O’Grady NP, Pittet D, eds. Catheter-Related Infections in the Critically Ill. New York, NY:

Kluwer Academic; 2004: 1-22.

5. Karchmer TB, Cook E, Palavecino E, Ohl C, Sherertz R. Needleless valve ports may be associated with a high rate of catheter-related bloodstream infection. In: Program and abstracts of the

15th Annual Scientific Meeting of the Society for Healthcare Epidemiologists of America. April 9, 2005.

6. Jarvis WR, Murphy C, Hall KK, Fogle PJ, Karchmer TB, Harrington G, Salgado C, Giannetta ET, Cameron C, Sherertz RJ. Health care-associated bloodstream infections associated with

negative-or positive-pressure or displacement mechanical valve needleless connectors. Clin Infect Dis. 2009; 49(12): 1821-1827.

7. CDC Vitalsigns making health care safer: Reducing bloodstream infections. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/vitalsigns/pdf/2011-03-vitalsigns.pdf

Published March, 2011. Accessed June 18, 2017.

8. Septimus EJ, Moody J. Prevention of device-related healthcare-associated infections [version 1; referees: 2 approved]. F1000Research. 2016; 5(F1000 Faculty Rev):65. doi:

10.12688/f1000research.7493.1

9. Zimlichman E, Henderson D, Tamir O, et al. Health care-associated infections: A meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013;1 73(22):

2039-2046.

10. Siempos II, Kopterides P, Tsangaris I, Dimopoulou I, Armaganidis AE. Impact of catheter-related bloodstream infections on the mortality of critically ill patients: A meta-analysis*. Crit Care

Med. 2009; 37(7): 2283-2289.

11. Blot SI, Depuydt P, Annemans L, Benoit D, Hoste E, De Waele JJ, Decruyenaere J, Vogelaers D, Colardyn F, Vandewoude KH. Clinical and economic outcomes in critically ill patients with

nosocomial catheter-related bloodstream infections. Clin Infect Dis. 2005; 41(11): 1591-1598.

12. Renaud B, Brun-Buisson C. Outcomes of primary and catheter-related bacteremia: a cohort and case-control study in critically ill patients. Am J Respir Crit Care Med. 2001; 163: 1584–1590.

13. Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch

Surg. 2001; 136: 229–234.

14. Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ. Attributable cost of catheter-associated bloodstream infections among intensive care patients in a nonteaching

hospital. Crit Care Med. 2006; 34: 2084–2089.



References cont.

15. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1994; 271: 1598–1601.

16. Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of

America. Clin Infect Dis. 2009; 49(1): 1-45.

17. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004; 30(1): 62-67.

18. Mermel LA. What is the predominant source of intravascular catheter infections? Clin Infect Dis. 2011; 52(2): 211-212.

19. Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter: A randomized, controlled trial.

Ann Intern Med. 1997; 127(4): 257-266.

20. Douard MC, Clementi E, Arlet G, et al. Negative catheter-tip culture and diagnosis of catheter-related bacteremia. Nutrition. 1994; 10(5): 397-404.

21. Dittmer ID, Sharp D, McNulty CA, Williams AJ, Banks RA. A prospective study of central venous hemodialysis catheter colonization and peripheral bacteremia. Clin Nephrol. 1999; 51(1): 34-39.

22. Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and epidemiology of catheter related infection with pulmonary artery Swan-Ganz catheters: A prospective study

utilizing molecular subtyping. Am J Med. 1991; 91(36):197S–205S.

23. Maki DG, Weise CE, Sarafin HW. A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med. 1977; 296(23): 1305-1309.

24. Segura M, Lladó L, Guirao X, Piracés M, Herms R, Alia C, Sitges-Serra A. A prospective study of a new protocol for ‘in situ’diagnosis of central venous catheter related bacteraemia. Clin Nutr.

1993; 12(2): 103-107.

25. Raad I, Costerton W, Sabharwal U, Sadlowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and

duration of placement. J Infect Dis. 1993; 168(2): 400-407.

26. O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011; 52(9): e162-e193.

27. The Joint Commission. Preventing central line–associated bloodstream infections: A global challenge, a global perspective. Oak Brook, IL: Joint Commission Resources; Mat 12, 2012.

https://www.jointcommission.org/assets/1/18/CLABSI_Monograph.pdf

28. Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D. Infusion Therapy Standards of Practice. J Infus Nurs. 2016; 39(suppl 1): S1-S59.

29. Marschall J, Mermel LA, Fakih M, et al. Strategies to prevent central line-associated bloodstream infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014; 35(7):

753-771.


© 3M 2016. All Rights Reserved© 3M 2016. All Rights Reserved3M Health Care AcademySM

15

Extraluminal Contamination



The majority of CRBSIs emanate from either the insertion site or the hub1-3

Organisms on the skin gain access to the bloodstream via migration along the external surface of the catheter

or catheter hub; both important routes of catheter-related bloodstream infections4-6

Soon after insertion, the extraluminal route or insertion site is the

predominate source of infection2,31-32

Whereas the intraluminal route (primarily the hub)

predominates after a more extended dwell time33-34


© 3M 2016. All Rights Reserved

Infusion Therapy Standards of Practice (2016)9Strategies to Prevent Central Line-Associated Bloodstream infections in Acute Care Hospitals (2014)8

Guide to Preventing Central-Line Associated Bloodstream Infections (2015)10

Best Practice Guidelines: Dressings

Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections (2017) CDC website link

SHEA/IDSA

APIC CDC

INS

• Standard 41: Practice Criteria J: Use chlorhexidine-impregnated dressings over CVADs to reduce infection risk…(I)

• Practice Criteria C: Assess the catheter-skin junction site and surrounding area for redness, tenderness, swelling, drainage by visual inspection and palpation(V).

• Chlorhexidine-impregnated dressings with an FDA cleared label that specifies a clinical indication for reducing CRBSI or CABSI are recommended to protect the insertion site of short-term, non-tunneled central venous catheters. (Category IA)

• Use chlorhexidine-containing dressings for CVCs in patients over 2 months of age (quality of evidence: I).

• If applicable, chlorhexidine-impregnated sponge dressing (1B) or chlorhexidine-impregnated dressing can be used. If a chlorhexidine-sponge dressing is used, it is oriented correctly and changed as the same time as the transparent dressing.

*According to CDC, due to a lack evidence, the use of CHG-impregnated dressings on patients younger than 18 years of age is an unresolved issue.

https://www.cdc.gov/infectioncontrol/guidelines/c-i-dressings/



Intravascular (IV) devices mean BSI rates3,27

Short Term (<10-14 days)

• Peripheral IV catheters

• Peripheral arterial catheters

• Central venous catheters (CVC)

oNon cuffed

oNot tunneled

Long Term (>10-14 days)

• Subcutaneous central venous ports

• Peripherally Inserted Central

Venous Catheter (PICC)

• Central venous catheters

o Tunneled

oCuffed

0.6 BSI /1000 catheters days PIVs

2.9 BSI/1000 catheters days

0.2 BSI/1000 catheter days


Cuffed: 1.1 Noncuffed: 2.8/1000 cd



Arterial

CVCs

Ports

PICCs

Tunneled-HPN

Dialysis



19

Beyond the guidelines: Clinical considerations for VAD site maintenance



Maintenance is for the life of the line

Insertion- the procedure represents only one aspect of the risk for CRBSI8

Maintenance- the risk of CRBSI extends to all aspects of nursing care and maintenance during the CVC dwell time8



Maki D, Ringer M. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991; 338(8763): 339-343.

10% PI 70% alcohol 2% CHG

N = 227 N = 227 N=214

CRI/100 cd 9.3 7.1 2.3

CR Bacteremia 2.6 2.3 0.5

Infected Catheters 7 6 1

Skin preps: Which is more effective?11



Skin microbes and preps12

0

0.5

1

1.5

2

2.5

3

3.5

Baseline Post-Prep Day 1

Me

an

Lo

g c

ou

nt

LO

G10

CF

U/C

M2

In-Vivo Suppresion of Microbe Regrowth

CHG prep reduces skin microbes, but some remain

Effective

Despite prep, skin flora regrow in 24 hours

Duration

Bashir MH, Olson LK, Walters SA. Suppression of regrowth of normal skin flora under chlorhexidine gluconate dressings applied to chlorhexidine gluconate-prepped skin. Am J Infect Control. 2012; 40(4): 344-348.



CRBSI: Most Common Pathogens7

O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011; 52(9): e162-e193.



Usability: Medical device errors30

Kohan C, Boyce J. A different experience with two chlorhexidine gluconate dressings for use on central venous devices. Am J Infect Control. 2013; 41 (6); S142–S143.

International Electrochemical Commission: IEC 62366-1:2015.



Site assessment

Recommends the use of transparent dressings because they permit continuous visual inspection of the catheter site.

Some dressing materials may obstruct site visibility and reduce securement.

CDC7

Gauze or sponges9

INS 2016 Standard 41 recommends assessment of the VAD catheter-skin junction site and surrounding area for redness, tenderness,

swelling, and drainage by visual inspection and palpation.

INS9



Phlebitis is related to bloodstream infection15

Mestre G, Berbel C, Tortajada P, et al, Successful multifaceted intervention aimed to reduced short peripheral venous catheter related adverse events: A quasi experimental study. Am J Infect Control. 2013; 41: 520-526.

Related to the incidence of peripheral catheter bloodstream infection (ratio 1 catheter related bloodstream infection for every 320 episodes of peripheral vein phlebitis)

Peripheral Vein Phlebitis

• The most used catheter CVC to PVC = 1:90• Peripheral catheters cause 19% of all CRBSIs• Peripheral catheters are the leading source of S. aureus BSI

Peripheral Catheters



Dressing Disruption

Do not rely on standard (non-bordered) VAD dressings as a means of stabilization… (I). 9

INS 2016

>10x risk of infection with 2+ unscheduled dressing changes16CRBSI Risk

Timsit JF, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R. Dressing disruption is a major risk factor for catheter-related infections. Crit Care Med. 2012; 40(6): 1707-1714.

0.1

1

10

100

1st 2nd final

Hazard ratio

# Dressing disruptions



Sutures

CDC and INS recommend the use of sutureless securement devices to reduce the risk of catheter movement, dislodgement and needlestick injury.7,9

Needle-stick Injury

Able to colonize the catheter and cause CRBSI.7



29

The difference is clear:Solving the site maintenance challenge



▪ 1st Synthesized & Marketed in 1950s– Over 55 years of efficacy and safety experience by chlorhexidine as a topical

antimicrobial

▪ Efficacy– Broad-spectrum activity against gram-positive and gram-negative bacteria,

anaerobes and aerobes, yeasts, and some lipid-envelope viruses. Not sporicidal. Demonstrated effectiveness against S. epidermidis, MRSA, VRE, K. pneumoniae, C. albicans

– Bacterial Susceptibility• After 50 years of research and experience, still no development of bacterial resistance

against CHG• A large multitude of genes will need to evolve to fend off CHG attack on bacteria

CHG Effectiveness



CHG Gel: Tested against 37 microbial strains17

Hensler JP, Schwab DL, Olson LK, Palka-Santini M. Growth inhibition of microorganisms involved in catheter-related infections by an antimicrobial transparent iv dressing containing chlorhexidine gluconate (CHG). Presented at: 19th Annual Conference of the European Society of Clinical Microbiology and Infectious Diseases; May 16-19, 2009: Helsinki, Finland.



Bashir (2012) Am J Infect Control12

CHG Gel Securement Dressing Results

DESIGN: Randomized controlled trial comparing

suppression of microbe regrowth chlorhexidine prep vs.

CHG gel vs CHG disk dressings.

METHODS:

o All patients treated with CHG skin prep

o Randomized to either:

• Transparent film dressing (control)

• CHG gel dressing

• CHG disk + transparent film dressing

RESULTS:

o n = 32 healthy subjects

o The CHG gel dressing demonstrated significantly greater microbial suppression than CHG disk on day 7 (p = 0.01).

Bashir MH, Olson LK, Walters SA. Suppression of regrowth of normal skin flora under chlorhexidine gluconate dressings applied to chlorhexidine gluconate-prepped skin. Am J Infect Control. 2012; 40(4): 344-348.

CHG Gel Dressing

CHG Disk Transparent Film Dressing



Kohan (2013) Am J Infect Control14

A Different Experience with Two Different Chlorhexidine Gluconate Dressings for use on Central Venous Devices


DESIGN: Clinical audit: correct application

METHODS:

o Staff re-educated on both products

o Evaluated application of CHG gel dressing in 2012, and CHG disk in 2009

RESULTS:

o n = 248 dressing applications

o CHG disk placed incorrectly 64%

o CHG gel pad of the CHG dressings placed correctly 100%

Kohan C, Boyce J. A different experience with two chlorhexidine gluconate dressings for use on central venous devices. Am J Infect Control. 2013; 41 (6); S142–S143.

CHG Gel Pad CHG Disk



CHG Gel: Site visibility to assess complications9

Erythema Extravasation

Catheter Damage

Catheter movement

Infiltration

Phlebitis

Bleeding



Securement18

9.2

6.2

3.9

0

1

2

3

4

5

6

7

8

9

10

3M™ ESD + CHG gel securement dressing

Sutures (3-0) Silk Tegaderm™ I.V. Film

Dressing

Competitive SecurementDressing

Po

un

ds

Mean Pull Force Required to Dislodge Inserted CVC Catheter


DESIGN:

o In-vivo mean pull force test

o Inserted CVC catheters with ESDs

RESULTS:

o 3M™ ESD + CHG gel securement dressing required significantly higher pull force than sutures + dressing or a competitive securement dressing.

Independent Lab in vivo testing: EM-05-012908 (Synchrony labs, Durham, NC.)



Karpanen (2016) Am J Infect Control19

Clinical evaluation of a chlorhexidine intravascular catheter gel dressing on short-term central venous catheters


DESIGN: Prospective, cross-over, comparative,

non-blinded, single center study.

METHODS:

o Microbial analysis of suture material, suture skin sites, CVC insertion sites and CVC tip sections after removal of antimicrobial CVC and either:

• Standard IV dressing

• CHG Gel IV dressing

RESULTS:

o Significant reduction of microbes at all sites using CHG gel dressing compared to standard dressing (p<0.001).

0

0.6

2

10.2

22.3

56

0 10 20 30 40 50 60

Insertion site

Suture-skin site

Suture material

CVC microbes median CFU/cm2

Standard Dressing (N= 136) CHG Gel Dressing (N= 136)

Karpanen TJ, Casey AL, Whitehouse T, Nightingale P, Das I, Elliott TSJ. Clinical evaluation of a chlorhexidine intravascular catheter gel dressing on short-term central venous catheters. Am J Infect Control. 2016: 44(1): 54-60.



37

CRBSI Clinical Studies



Safdar (2014) Crit Care Med20

Chlorhexidine-impregnated dressing for the prevention of CRBSIs: A meta-analysis

Safdar N, O’Horo JC, Ghufran A, et al. Chlorhexidine-impregnated dressing for prevention of CRBSIs: A meta-analysis. Crit Care Med. 2014: 42(7); 1703-1713.

Meta-analysis: CHG Dressings

DESIGN: Meta-analysis

METHODS:

o Included RCTs evaluating effectiveness of CHG disk or CHG gel dressing or a non-CHG dressing on CRBSI

RESULTS:

o CVC and arterial catheters

o 6,067 patients

o 5,586 catheters (CHG group)

o 5,628 (conventional group)

o Catheter dwell: 5.6 – 71.5 days

o Low incidence of contact dermatitis

14.3

2.1

6.8

1.1

0

2

4

6

8

10

12

14

16

Catheter Colonization CRBSI

Catheter Colonization (% of catheters) & CRBSI (% of patients)

Control CHG

p <0.001

p = 0.009



Timsit (2012) Am J Respir Crit Care Med21

Randomised controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing CRBSIs in critically ill adults


DESIGN: Randomised controlled trial comparing major CRI with or without CRBSI and catheter colonization rates

METHODS:

o Patients with CVC and/or arterial catheters randomized to:

• CHG Gel IV Dressings

• Non-chlorhexidine dressings

o 12 ICUs in France

RESULTS:

o 1,879 patients, 4,163 catheters, 34,339 catheter-days

Timsit JF, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M et al. Randomised controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing CRBSIs in critically ill adults, Am J Resp Crit Care Med. 2012: 186(12): 1272-1278.



Timsit (2012): CVC and Arterial Catheters21

Results:

P= 0.02

1.3

0.5

0

0.2

0.4

0.6

0.8

1

1.2

1.4

Non CHG dressing CHG dressing

CRBSI Rate (per 1000 catheter days)

60% reduction

10.9

4.3

0

2

4

6

8

10

12

Non CHG Dressings CHG Dressings

Catheter Colonization Incidence (per 1000 catheter days)

61% reduction

P <0.0001



Camins (2010) Infect Control Hosp Epidemiol22

A Crossover Intervention Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BioPatch®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients

Hemodialysis Tunneled Catheters Study

DESIGN: Prospective non-blinded cross-over intervention trial measuring CRBSI rates

INTERVENTION:

• Patients with tunneled HD catheters: Standard dressing or Standard dressing with CHG sponge.

• Two outpatient dialysis centers

RESULTS:

• n = 121 patients with tunneled HD catheters

• The use of the CHG-impregnated sponge dressing did not decrease CRBSI (p = 0.46)

5.2

6.3

0

1

2

3

4

5

6

7

Control group CHG sponge group

CRBSI Rates/1000 Dialysis Sessions

Camins BC, Richmond AM, Dyer KL, et al. A crossover intervention trial evaluating the efficacy of a chlorhexidine-impregnated sponge (BioPatch®) to reduce catheter-related bloodstream infections in hemodialysis patients. Infect Control Hosp Epidemiol. 2010; 31(11): 1118–1123.



Righetti M, Palmieri N, Bracchi O, et al. Tegaderm™ CHG dressing significantly improves catheter infection rate in hemodialysis patients. J Vasc Access. 2016; 17(5): 417-422.

Righetti (2017) J Vasc Access23

Tegaderm™ CHG dressing significantly improves catheter infection rate in hemodialysis patients


DESIGN: Prospective Randomized cross over trial measuring CRI and CRBSI rates in HD patients

METHODS:

o Patients with tunneled HD catheters randomized to either:

• Standard dressing

• Tegaderm™ CHG Dressing

RESULTS:

o n = 59

o Estimated annual savings of €237,940 with use of Tegaderm™ CHG Dressings

1.21

0.65

0.28

0.09

0

0.2

0.4

0.6

0.8

1

1.2

1.4

CRI CRBSI

CRI & CRBSI Rate (per 1000 catheter days)

Standard dressing CHG

p = 0.02 p = 0.05



Apata, I, Hanflet, J, Bailey, J, et al. Chlorhexidine-impregnated transparent dressings decrease catheter-related infections in hemodialysis patients: a quality improvement project. J Vasc Access. 2017; 18(2): 103-108.

Apata (2017) J Vasc AccessChlorhexidine-impregnated transparent dressings decrease catheter-related infections in hemodialysis patients: a quality improvement project


DESIGN: Prospective Before and After Intervention Measuring CRI Rates in Patients with Dialysis Catheters

METHODS:

o Patients with tunneled HD catheters: 3 outpatient units

• Control: Dry gauze dressing with ointment changed 3x/week

• Intervention: CHG Gel Dressing changed weekly

RESULTS:

o CHG-transparent gel dressing decreased CRI rates in patients with tunneled dialysis catheters

0.82

0.26

0.88

1.69

1.86

1.89

0 0.5 1 1.5 2

EDC

EDG

EDN

CRI Rates (per 1,000 cd) per respective outpatient units

Pre-Intervention Intervention

P = <0.05

P = <0.05

P = <0.05



Biehl (2016) Ann Oncol24

A randomized trial on chlorhexidine dressings for the prevention of CRBSIs in neutropenic patients

CHG Gel Dressing Study Results

DESIGN: Open-label randomized, multi-center trial measuring definite CRBSI within the first 14 days of CVC placement

METHODS:

o Patients with CVCs randomized to either: Standard dressing or CHG Gel Dressing

o 10 German hematological depts

RESULTS:

o n = 613

o dCRBSI: CHG 2.6% vs control 3.9% (p = 0.375)

3.90%

2.60%

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

3.00%

3.50%

4.00%

4.50%

Transparent dressing(N=306)

CHG gel dressing(n=307)

Definite CRBSI w/in first 14 days of CVC placement

Biehl LM, Huth A, Panse J, et al. A randomised trial on chlorhexidine dressings for the prevention of CRBSIs in neutropenic patients. Ann Oncol. 2016; 10: 1916-1922.



Scheithauer (2016) Clin Infect Dis25

Significant Reduction of External Ventricular Drainage–Associated Meningoventriculitis by Chlorhexidine-Containing Dressings: A Before-After Trial

Scheithauer S, Schulz-Steinen H, Hollig A, et al. Significant Reduction of External Ventricular Drainage–Associated Meningoventriculitis by Chlorhexidine-Containing Dressings: A Before-After Trial. Clin Infect Dis. 2016; 62(3): 404-405. doi: 10.1093/cid/civ887


• DESIGN

• RESULTS

o

DESIGN: Before and after intervention study comparing external ventricular drainage (EVD)-associated meningoventriculitis (MV)

METHODS:

o Pre-Intervention: Gauze dressing

o Intervention: CHG gel dressing

RESULTS:

o 5383 EVDs (Pre-intervention)

o 2512 EVDs (Intervention)

o No adverse events reported

6.98

1.70

0

1

2

3

4

5

6

7

8

Pre Intervention Intervention

EVD associated MV (per 1000 EVD days)

p = 0.005



Grigonis (2016) AJCC28

Use of a Central Catheter Maintenance Bundle in Long-term Acute Care Hospitals (LTACHs)

Disinfecting Cap Study Results54

DESIGN: Before and after intervention study bundle

in 30 LTACHs

INTERVENTION:

o Implemented central line bundle

o Bundle included: education, mandatory use of disinfecting caps on CVC and tubing, chlorhexidine gluconate dressings, and formation of central line team

RESULTS:

o Infection reduction translate to a savings of approximately $3.7 million annually for the 30 LTACHs

o Potentially saved 20 patients’ lives

Grigonis AM, Dawson AM, Burkett M, et al. Use of a central catheter maintenance bundle in long-term acute care hospitals. Am J Crit Care. 2016; 25(2): 165-172.

1.28

0.96

0

0.2

0.4

0.6

0.8

1

1.2

1.4

Pre intervention Intervention

CLABSI Standardized Infection Ratio (SIR)54

p= 0.01

25% reduction

Pre intervention(2/2012-7/2012)

Intervention(8/2012-1/2013)



Thokala P, (2016) J Infec Prev29

Thokala P, Arrowsmith M, Poku E, et al. Economic impact of Tegaderm™ CHG chlorhexidine gluconate IV securement dressing in critically ill patients. J Infect Prev. September 17, 2016; (5): 216-223.

Economic impact of Tegaderm™ CHG IV securement dressing in critically ill patients



48

Medical Adhesive-Related Skin Injury (MARSI)



McNichol L, Lund C, Rosen T, Gray M. Medical Adhesives and Patient Safety: State of the Science: Consensus Statements for the Assessment, Prevention, and Treatment of Adhesive-Related Skin Injuries. J Wound Ostomy Continence Nurs. 2013; 40(4):365-380.

Central Vascular Access Device (CVAD) Stabilization Standard 37, page S72-74

• Apply barrier solutions to skin exposed to adhesive dressing to reduce risk of Medical Adhesive-Related Skin Injury (MARSI). (Level I)

Skin preparation Best Practice: protect skin with an alcohol-free barrier film

Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D. Infusion Therapy Standards of Practice. J Infus Nurs. 2016; 39(suppl 1): S1-S59.



• Forms a protective interface between the adhesive and skin

• Adhesive removal removes barrier film, not epidermal cells

This

Not this

Best Practice: protect skin with an alcohol-free barrier film



So how do we prevent MARSI? Address causal factors

Type of adhesive Skin Preparation Application Technique Removal Technique

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://solutions.3m.co.za/wps/portal/3M/en_ZA/EU-Skin-Wound-Care/Home/Brands/Tegaderm/CHG/&ei=JqfbVK-DOIKpgwTl24DADg&bvm=bv.85761416,d.eXY&psig=AFQjCNFSVNuqSgVRkfrpJcd_fV1Izzh3UA&ust=1423767687094152

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://solutions.3mphilippines.com.ph/wps/portal/3M/en_PH/SWC/main/brands/tegadermiv/&ei=E6jbVLmgMo_igwSOiIOwAQ&bvm=bv.85761416,d.eXY&psig=AFQjCNFI4oVlYV7Fo7RWGiMsl5yWwfwlRg&ust=1423767941677885



What Does Some of the Evidence Tell Us?A recent study evaluated skin condition in 100 patients with peripherally inserted central catheters36

-

10

20

30

40

50

60

70

Without Cavilon NSBF With Cavilon NSBF

% o

f p

ati

en

ts

n=100*rash/redness, peeling, maceration, adhesive transfer

% Patients with skin complications* (PICC lines)

A significant decrease in local skin

complications with use of Cavilon™ NSBF was

demonstrated

Skin damage is a local complication that can lead to increased risk of colonization and infection37-38

Skin protectant plays an important role in reducing the local complications in PICC linesGeorge M. Use of a barrier film (3M™Cavilon™ No Sting Barrier Film) to reduce local skin complications around PICC lines: A randomized prospective controlled study. WCET Journal. 2016; 36(4): 8-13.

Roth RR, James WD. Microbial Ecology of the Skin. Annu Rev Microbiol. 1988; 42: 441-464.

Abad CL, Safdar N. Catheter-related Bloodstream Infections. Infect Dis. (Special Edition) 2011; 84-98. McMahon Publishing.



Resources39-40

Hitchcock J, Savine L. Medical adhesive-related skin injuries associated with vascular access. Br J Nurs. 2017; 26(8): S4-S12.Broadhurst D, Moureau N, Ullman AJ. Management of Central Venous Access Device-Associated Skin Impairment: An Evidence-Based Algorithm. J Wound Ostomy Continence Nurs. 2017; 44(3): 211-220.



54

CHG Clinical Study Summary Slide



Summary of Clinical Evidence

Reduce the risk of CRBSI

• CRBSI reduction 60%21

• Catheter colonization reduction 61%21

• CVC and arterial catheters21

Reduce Cost

• More cost effective than standard dressing29

• A group of 30 Long Term Acute Care Hospital (LTACHs) approximated annual savings of $3.7 million.28

Transparent

• CHG gel dressing meets transparent securement dressing recommendations for all types of VADs.7,9

Increase Compliance• 100% compliance of CHG gel placement,

compared with only 36% CHG disk.14

• CHG gel can be applied to a variety of different catheter types, sizes and locations.



BSI

• ALL vascular access devices increase the risk of BSI

• Contamination can be introduced into bloodstream via:

• Extraluminal route

• Intraluminal route

• Clinical considerations are important when implementing

evidence based interventions to address catheter

maintenance challenges



Reducing the risk of BSI A comprehensive approach to maintenance is critical to reduce risk at

all access points.



58

Thank you

Questions?



References1. Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by

the Infectious Diseases Society of America. Clin Infect Dis. 2009; 49(1): 1-45.

2. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004;

30(1): 62-67.

3. Mermel LA. What is the predominant source of intravascular catheter infections? Clin Infect Dis. 2011; 52(2): 211-212.

4. Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter:

A randomized, controlled trial. Ann Intern Med. 1997; 127(4): 257-266.

5. Douard MC, Clementi E, Arlet G, et al. Negative catheter-tip culture and diagnosis of catheter-related bacteremia. Nutrition. 1994; 10(5): 397-404.

6. Dittmer ID, Sharp D, McNulty CA, Williams AJ, Banks RA. A prospective study of central venous hemodialysis catheter colonization and peripheral bacteremia.

Clin Nephrol. 1999; 51(1): 34-39.

7. O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011; 52(9): e162-e193.

8. Marschall J, Mermel LA, Fakih M, et al. Strategies to prevent central line-associated bloodstream infections in acute care hospitals: 2014 update. Infect Control

Hosp Epidemiol. 2014; 35(7): 753-771.

9. Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D. Infusion Therapy Standards of Practice. J Infus Nurs. 2016; 39(suppl 1): S1-S59.

10. Association for Professionals in Infection Control and Epidemiology. APIC Implementation Guide: Guide to Preventing Central Line-Associated Bloodstream

Infections. 2015. https://apic.org/Resource_/TinyMceFileManager/2015/APIC_CLABSI_WEB.pdf. Accessed September 2017.

11. Maki D, Ringer M. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and

arterial catheters. Lancet. 1991; 338(8763): 339-343.

https://apic.org/Resource_/TinyMceFileManager/2015/APIC_CLABSI_WEB.pdf



References cont.12. Bashir MH, Olson LK, Walters SA. Suppression of regrowth of normal skin flora under chlorhexidine gluconate dressings applied to chlorhexidine gluconate-

prepped skin. Am J Infect Control. 2012; 40(4): 344-8.

13. Aslam, S, Effect of antibacterials on biofilms. Am J Infect Contr. 2008; 36:S175.e9-S175.e11.i

14. Kohan C, Boyce J. A different experience with two chlorhexidine gluconate dressings for use on central venous devices. Am J Infect Contr. 2013; 41 (6); S142–

S143.

15. Mestre G, Berbel C, Tortajada P, et al, Successful multifaceted intervention aimed to reduced short peripheral venous catheter related adverse events: A quasi

experimental study. Am J Infect Control. 2013; 41: 520-526.

16. Timsit JF, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R. Dressing disruption is a major risk factor for catheter-related infections. Crit

Care Med. 2012; 40(6): 1707-1714.

17. Hensler JP, Schwab DL, Olson LK, Palka-Santini M. Growth inhibition of microorganisms involved in catheter-related infections by an antimicrobial transparent

IV dressing containing chlorhexidine gluconate (CHG). Presented at: 19th Annual Conference of the European Society of Clinical Microbiology and Infectious

Diseases; May 16-19, 2009: Helsinki, Finland.

18. Independent Lab in vivo testing: EM-05-012908 (Synchrony labs, Durham, NC.)

19. Karpanen TJ, Casey AL, Whitehouse T, Nightingale P, Das I, Elliott TSJ. Clinical evaluation of a chlorhexidine intravascular catheter gel dressing on short-term

central venous catheters. Am J Infect Control. 2016: 44(1): 54-60.

20. Safdar N, O’Horo JC, Ghufran A, et al. Chlorhexidine-impregnated dressing for prevention of CRBSIs: A meta-analysis. Crit Care Med. 2014: 42(7); 1703-1713.

21. Timsit JF, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M et al. Randomised controlled trial of chlorhexidine dressing and highly adhesive dressing

for preventing CRBSIs in critically ill adults, Am J Resp Crit Care Med. 2012: 186(12): 1272-1278.



References cont.22.Camins BC, Richmond AM, Dyer KL, et al. A crossover intervention trial evaluating the efficacy of a chlorhexidine-impregnated sponge (BioPatch®) to reduce

catheter-related bloodstream infections in hemodialysis patients. Infect Control Hosp Epidemiol. 2010; 31(11): 1118–1123.

23.Righetti M, Palmieri N, Bracchi O, et al. Tegaderm™ CHG dressing significantly improves catheter infection rate in hemodialysis patients. J Vasc Access. 2016;

17(5): 417-422.

24.Biehl LM, Huth A, Panse J, et al. A randomised trial on chlorhexidine dressings for the prevention of CRBSIs in neutropenic patients. Ann Oncol. 2016; 10: 1916-

1922.

25. Scheithauer S, et. al., Significant reduction of external ventricular drainage–associated meningoventriculitis by chlorhexidine-containing dressings: A before-

after trial, Clin Infect Dis. 2016, 62 (3): 404-405. doi: 10.1093/cid/civ887

26. Mermel, et. al., Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection: 2009 Update by the Infectious

Diseases Society of America, Clinical Infectious Diseases, 2009; 49:1-45

27. Maki, Catheter BSI rates: Clinical Infectious Diseases, 2002; 34:1232-1262

28. Grigonis AM, Dawson AM, Burkett M, et al. Use of a central catheter maintenance bundle in long-term acute care hospitals. Am J Crit Care. 2016; 25(2): 165-

172.

29. Thokala P, Arrowsmith M, Poku E, et al. Economic impact of Tegaderm™ CHG chlorhexidine gluconate IV securement dressing in critically ill patients. J Infect

Prev. September 17, 2016; (5): 216-223.

30. International Electrochemical Commission: IEC 62366-1:2015 IEC 201

31. Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and epidemiology of catheter related infection with pulmonary artery Swan-Ganz

catheters: A prospective study utilizing molecular subtyping. Am J Med. 1991; 91(36):197S–205S.

32. Maki DG, Weise CE, Sarafin HW. A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med. 1977; 296(23): 1305-

1309.



References cont.33. Segura M, Lladó L, Guirao X, Piracés M, Herms R, Alia C, Sitges-Serra A. A prospective study of a new protocol for ‘in situ’diagnosis of central venous catheter

related bacteraemia. Clin Nutr. 1993; 12(2): 103-107.

34. Raad I, Costerton W, Sabharwal U, Sadlowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship

between luminal colonization and duration of placement. J Infect Dis. 1993; 168(2): 400-407.

35. McNichol L, Lund C, Rosen T, Gray M. Medical Adhesives and Patient Safety: State of the Science: Consensus Statements for the Assessment, Prevention, and

Treatment of Adhesive-Related Skin Injuries. J Wound Ostomy Continence Nurs. 2013; 40(4):365-380.

36. George M. Role of skin protectant in reducing the local complications in PICC lines. Poster presentation at the 2013 meeting of the Infusion Nursing Society

37. Roth RR, James WD. Microbial Ecology of the Skin. Annu. Rev. Microbiol. 1988; 42: 441-464

38. Abad CL, Safdar N. Catheter-related Bloodstream Infections. Infect Dis. (Special Edition) 2011. McMahon Publishing

39.Hitchcock J, Savine L. Medical adhesive-related skin injuries associated with vascular access. Br J Nurs. 2017; 26(8): S4-S12.

40.Broadhurst D, Moureau N, Ullman AJ. Management of Central Venous Access Device-Associated Skin Impairment: An Evidence-Based Algorithm. J Wound

Ostomy Continence Nurs. 2017; 44(3): 211-220.

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BSI: Addressing Clinical Challenges with Catheter Maintenance · 13. Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related