Biopatch Class Effect

(1)

BIOPATCH

®

_{Protective Disk with CHG is the Only Dressing}

with an FDA-Cleared Indication for CRBSI Prevention

CRBSIs are a common complication of vascular access,

7

_{and are associated with extended hospital stays, substantial costs,}

and in some cases increased mortality.

11-14

_{Evidence-based guidelines from SHEA/IDSA}

6

_{for the prevention of CRBSIs include}

use of a catheter checklist, proper hand hygiene, use of sterile barriers and antiseptic for skin preparation, monitoring of

catheters and dressings after insertion, and removal of nonessential catheters. Furthermore, SHEA/IDSA recommend the use

of a CHG-impregnated sponge dressing for the prevention of CRBSI based on RCTs conducted on BIOPATCH

®

_{. None of the other}

antimicrobial dressings have been evaluated using RCTs for clinical efﬁ cacy in reducing infections and are not cleared by the FDA

for that indication.

15-17

Given the high costs and mortality associated with CRBSIs,

11-14

_{it is important to use BIOPATCH}

®

_{, a device with documented}

ability to reduce the incidence of CRBSIs, skin colonization, and local infections associated with catheter use. BIOPATCH

®

remains the only dressing with an FDA-cleared indication for the prevention of CRBSIs.

Visit www.BIOPATCH.com for Full Prescribing Information ©Ethicon, Inc. 2010 BP-471-10-12/12 The third-party trademarks used herein are trademarks of their respective owners.

1. Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, et al. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001;107(6):1431-1436.

2. Ho KM, Litton E. Use of chlorhexidine-impregnated dressing to prevent vascular and epidural catheter colonization and infection: a meta-analysis. J Antimicrob Chemother. 2006;58(2):281-287. 3. Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz

S, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88(3):267-272. 4. Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial.

JAMA. 2009;301(12):1231-1241.

5. Soares I, Carneiro AV. Drug class effects: deﬁ nitions and practical applications. Rev Port Cardiol. 2002;21(9):1031-1042.

6. Marschall J, Mermel LA, Classen D, Arias KM, Podgorny K, Anderson DJ, et al. Strategies to prevent central line-associated bloodstream infections in acute care hospitals. Infect Control

Hosp Epidemiol. 2008;29 Suppl 1:S22-30.

7. 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.

8. Cumulative Antimicrobial Release Comparison: Foam discs were soaked in 0.9% saline at room temperature for the desired time point. After each time point, the discs were removed and CHG and PHMB concentration in the solution measured by HPLC. The disc was transferred to a fresh saline solution for the next measurement. In Kendall AMD, the release was minimum, and thus the PHMB was measured as the difference between the maximum total amount on each disc and the amount remaining in the disc after each time point. Data on ﬁ le. Ethicon, Inc.

9. Westergom C. Quantitative Analysis of Angular Coverage between Two Antimicrobial Catheter Dressings; 2010. Data on ﬁ le. Ethicon, Inc.

10. CHG Transfer onto Porcine Skin: 2 X 2” pieces of porcine skin were cleaned, dried and placed on top of PBS saturated c-fold towels. Catheters were inserted through a 10 mm biopsy punch and dressed according to either product’s directions for use. Samples were incubated at 30° C for 24 hours. The skin was removed, stained with Sodium Hypobromite solution and photographed. Data on ﬁ le. Ethicon, Inc.

11. 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(20):1598-1601. 12. Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y.

Economics of central line-associated bloodstream infections. Am

J Med Qual. 2006;21(6 Suppl):7S-16S.

13. 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(8):2084-2089.

14. O’Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002;51(RR-10):1-29. 15. GuardIVa [package insert]. Dublin: HenCon Medical Techologies,

Europe Ltd.

16. Kendall AMD Antimicrobial Foam Fenestrated

Disc Dressing [package insert]. Mansﬁ eld, MA: Covidien; 2009. 17. Tegaderm [package insert]. St. Paul, MN: 3M; 2009.

References

(2)

Key elements for the choice of antimicrobial dressings to prevent infections associated with intravascular catheters

include the ability of the antimicrobial agent (1) to be released from the dressing and to reach all areas of skin surrounding

the catheter; (2) to have activity against a wide spectrum of microorganisms, including drug-resistant bacteria such

as methicillin-resistant Staphylococcus aureus (MRSA); and (3) to demonstrate clinical efﬁ cacy against catheter

colonization and infections.

Several antimicrobial dressings, made from different materials and containing various antimicrobial agents, are available for

use with intravascular catheters. These include, but are not limited to: BIOPATCH

®

_{*, GuardIVa}

TM

_{, Tegaderm™ CHG, Kendall™}

AMD Foam Disc, and Algidex™ Ag IV Patch. However, it is important to understand that there are some differences between

these products.

There is no “class effect” for antimicrobial dressings

Drugs with similar chemical structures or mechanisms of action are often thought to produce similar clinical outcomes – a

concept known as the “class effect”.

5

_{Sometimes drugs within a class are considered to be interchangeable; however, even}

within drug classes there can be important distinctions in clinical effect. The analogy of a “class effect” does not extend

to medical devices, such as antimicrobial dressings. Medical devices contain many components and the effect of all the

components working together must be considered when evaluating the effectiveness of a device.

The SHEA/IDSA

6

_{guidelines recommend the use of a chlorhexidine gluconate (CHG)-impregnated sponge dressing}

in patients older than 2 months if the catheter-related bloodstream infection (CRBSI) rate remains higher than the

institutional goal, the patient has limited venous access and a history of recurrent CRBSI, or the patient is at risk of severe

sequelae from a CRBSI. These recommendations are based on evidence from randomized controlled trials (RCT’s) showing

that a speciﬁ c CHG sponge dressing* signiﬁ cantly reduced clinical outcomes of catheter colonization and CRBSIs.

1-4,7

BIOPATCH

®

_{is a medical device comprised of a unique and proprietary combination of antimicrobial agent, dressing}

materials, and dressing design components. Other antimicrobial catheter site dressings may have different combinations

of these device components which may affect their ability to deliver similar clinical outcomes.

BIOPATCH

®

_{is the only dressing with an FDA-cleared}

indication for the prevention of CRBSIs, and

the only product with proven clinical efﬁ cacy

1- 4

Not all antimicrobials are the same.

Different antimicrobial agents can be used in a catheter site

dressing, eg, CHG, PHMB, or Silver. In choosing an antimicrobial

agent, you must consider:

• The amount of agent loaded into the dressing as well as the

sustained release of the agent from the dressing over the

duration of time it is worn.

• The interaction of the antimicrobial agent with the dressing

material which could affect its release.

• The ability of the antimicrobial agent to bind to and build up

on the skin and provide persistent antimicrobial protection.

Does a “Class Effect” Exist for Anti-Microbial Catheter Site Dressings?

Dressings can be composed of different materials such as foams,

alginates, or hydrogels. In selecting a dressing material, you must consider:

Evidence-Based Decision to use BIOPATCH

®

There are many options but only one choice

Tegaderm

TM

_CHG

111111

222222222

There is no “Class Effect” for BIOPATCH

®

_{and other antimicrobial dressings}

*BIOPATCH®_{, Ethicon Inc., Somerville, NJ}

The dressing shape and material properties can have an impact on the ability of the dressing to provide 360° protection of the

skin around the insertion site (Figure 2), and the ability to easily remove the dressing without impacting the integrity of the skin and

positioning of the catheter (Figure 3).

Not all designs are the same.

333333333333

Figure 1. Cumulative Antimicrobial

Release Comparison

8 4 5 6 7 8 9 10 15 20 25 30 el ea se d (m g) fr o m Ke n d all A M D Fo am Di sk re le as ed (mg ) fr om B io p at ch a nd G ua rd Iv a

Cumulative Release of Antimicrobial Agents from Foam Catheter Dressings

Biopatch GuardIVA Kendall AMD Foam Disk

CHG 0 1 2 3 4 5 6 7 8 9 10 0 5 10 15 20 25 30 0 1 2 3 4 5 6 7 C u mu la ti ve PHM B re le as ed (m g) fr o m Ke n d all A M D Fo am Di sk C u mu la ti ve C HG r el ea se d (mg ) f ro m B io p at ch a nd G ua rd Iv a Days

Cumulative Release of Antimicrobial Agents from Foam Catheter Dressings

Biopatch GuardIVA Kendall AMD Foam Disk

CHG CHG PHMB Cumula ti ve CHG r eleased (mg) fr om BIOP AT CH ® and Guar dIV a TM Cumula ti v e PHMB r eleased (mg) fr om Kendall TM AMD F oam Disc f oam disk BIOPATCH® GuardIVaTM KendallTM_AMD Foam Disc



The material interaction with the antimicrobial agent, and the impact of any additional ingredients which could potentially

interact with the antimicrobial agent and affect its release from the dressing.



The material design and properties and whether they allow for easy removal, thereby minimizing disruption to skin integrity.



The material’s ability to quickly absorb blood and bodily ﬂ uids to prevent potential issues such as skin maceration and

potential bacterial growth.

Figure 2. BIOPATCH

®

_{Provides 360° CHG Coverage}

9

BIOPATCH

® A B

Tegaderm™ CHG

C D

Figure 3. Adhesive Properties Can Complicate Dressing Removal

CHG transfer from BIOPATCH® and Tegaderm™ CHG to porcine skin designed to maximize contact of the dressing with the skin and CHG migration. BIOPATCH® provides more complete, continuous protection of the skin around the insertion site.10

Gel pad adhesive properties can complicate ease of removal from the skin (A) and catheter hub (B).

A

Not all dressing materials are the same.

B

Algidex™ Ag

IV Patch

Kendall

™