CHG Sponge Dressing Clinically Proven to Reduce Infections1

Topical Hemostatic IV Dressing Containing CHG as a Preservative

®® Protective Disk with CHG

Reducing CRBSIs Requires Evidence Based Medicine

Critical design & performance differences include: • The proprietary BIOPATCH Disk foam is different in structure from GuardIVa®

– BIOPATCH Disk contains more CHG4,5 (4X) than GuardIVa®

– BIOPATCH Disk releases more CHG6 (5X) than GuardIVa® – GuardIVa® allows bacterial growth in vitro6 and BIOPATCH Disk does not

CDC Recommends a CHG Sponge Dressing. Why?

The CDC Guidelines’ stated intent is “to provide evidence-based recommendations for preventing intravascular catheter-related infections.”2

For patients aged 18 years and older: Chlorhexidine-impregnated dressings with an FDA-cleared label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated bloodstream infection (CABSI) are recommended to protect the insertion site of short-term, non-tunneled central venous catheters (1A).”2 The updated recommendation has been designated Category 1A - the highest level of CDC recommendation for implementation.2

Studies cited to support this CHG dressing recommendation were BIOPATCH Disk clinical studies.3 GuardIVa® Antimicrobial Hemostatic IV Dressing is currently being marketed as a CHG dressing following the CDC Guidelines’ publication. It does not have any randomized controlled studies supporting its efficacy in reducing infections.

BIOPATCH Disk is the only polyurethane foam protective disk with a cleared indication and proven to reduce the incidence of catheter-related bloodstream infections (CRBSIs), local infections and skin colonization in patients with central venous and arterial catheters.

The CDC Guidelines’ stated intent is “to provide evidence-

based recommendations for preventing intravascular

catheter-related infections.” 2

BIOPATCH Disk is the only polyurethane foam protective disk with a cleared indication

and proven to reduce the incidence of catheter-related

bloodstream infections (CRBSIs), local infections and skin colonization in patients

with central venous and arterial catheters.

There is no generic replacement for clinically proven BIOPATCH® Protective Disk with CHG

0

20

40

60

80

100

BIOPATCH GUARDIVA

1” discs with 4mm center holes

CHG

(mg)

BIOPATCH Disk contains almost 4x the amount

of CHG as GuardIVa®

BIOPATCH Disk GuardIVa®

Comparison of Total CHG Content 4,5

20

5

10

15

20

25

30

0 1 2 3 4 5 6 7

Cu

mu

lati

ve C

HG

rel

ease

d (m

g) f

rom

Bio

pat

ch a

nd

G

uar

dIv

a

Days

In vitro Cumulative Release of Antimicrobial Agents from different Catheter Dressings

BIOPATCH® GuardIVa

18 hours: Time bacteria starts repopu ng the skin

*1

*1

*2

3 6 12 18(hours)

*2. In vitro testing demonstrated that GuardIVa releases the same amount of CHG in7 days as released by BIOPATCH® in 3 hours

*1. Bacteria starts repopulating the skin at about 18 hours. In vitro testing showed that by 18 hours BIOPATCH had released 20 mg CHG, while GuardIVa only released 2mg.

18 Hours

®

®

®

®

Cum

ulati

ve C

HG

rele

ased

(mg)

from

BI

OPA

TCH

Dis

k an

d G

uard

IVa®

Comparison of CHG Release 6

Cumulative CHG Release Comparison: Each test article was placed in 0.9% saline at room temperature for 24 hours. After 24 hours the discs were removed and the CHG concentration in the solution was measured by HPLC. The discs were then transferred to a fresh saline solution for the next 24 hour measurement for a total duration of 7 days.6

Reducing CRBSIs Requires Evidence Based Medicine

BIOPATCH Disk Prevents Bacterial Growth6 in-vitro

A. baumannii

Inhibition of bacterial growth in the central opening (catheter insertion point)

Inhibition of bacterial growth around perimeter of the BIOPATCH Disk

GuardIVa® Allows Bacterial Growth6 in-vitro

Visual bacterial growth seen beneath the GuardIVa® disk

Bacteria (lack of inhibition) seen in central opening and around disk perimeter A. baumannii

P. aeruginosa

BIOPATCH Disk GuardIVa®

Lead AuthorStatistically significant reduction of CRBSIs in

central venous and arterial catheters

Statistically significant reduction in catheter colonization in central

venous and arterial catheters HAS NEVER BEEN CLINICALLY

SHOWN TO REDUCE INFECTION OR REDUCE CATHETER

COLONIZATION

Timsit1 4 4

Garland7 n/a 4

Ho8 4 4

Levy9 4 4

Ruschulte10 4 4

Maki11 4 4

Evidence Based Decision Making

Given the high costs and mortality12 associated with CRBSIs, it is important to use a device with repeatedly proven efficacy in the reduction of CRBSI incidence, skin colonization, and local infections with catheter use.

The CDC guidelines provide evidence based recommendations for preventing CRBSIs. GuardIVa® currently does not have any clinical evidence showing a reduction in CRBSIs5. BIOPATCH Disk is the only CHG impregnated sponge dressing with a cleared indication for reducing CRBSIs, local infections and skin colonizations in patients with central venous and arterial catheters.

GuardIVa®is not a generic BIOPATCH Disk

There is no generic replacement for clinically proven BIOPATCH® Protective Disk with CHG

The highlighted studies were cited by the CDC for the 1A recommendation

References: 1. Timsit JF, Schwebel C, Bouadma L, 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; 301:1231–41. 2. 2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections. An update to the 2011 guidelines for the prevention of intravascular catheter-related infections from the Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality and Promotion. Published Nov 1, 2017. (https://www.cdc.gov/infectioncontrol/guidelines/bsi/c-i-dressings/index.html). 3. 2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections Published Nov 1, 2017. (https://www.cdc.gov/infectioncontrol/guidelines/bsi/c-i-dressings/index.html). 4. ADAPTIV Document number LAB-0010999 10558-731-03 BioPatch Non-CE Marked IFU, Retrieved June 6th, 2013. 5. GuardIVa Instructions for Use. Retrieved 3/28/18. http://www.bardaccess.com/assets/literature/0736109_guardiva_ifu_web.pdf. 6. Han Y, Xing Y. In vitro CHG Release Study for a Competitive Antimicrobial Foam HemCon GuardIVa® in Comparison with BioPatch. Ethicon Notebook. 30 September, 2010; 4035:128-133. 7. Garland JS, Alex CP, Mueller CD, 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; 107:1431–6. 8. 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; 58:281–7. 9. Levy I, Katz J, Solter E, et al. Chlorhexidine-impregnated dressing for prevention of colonization of central venous catheters in infants and children: a randomized controlled study. Pediatr Infect Dis J 2005; 24:676–9. 10. 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. 11. Maki DG, Mermel LA, Kluger D, et al. Prevention of intravascular catheter-related infection-a prospective, randomized, controlled, multicenter study. Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 2000, page 422. 12. Umscheid CA, Mitchell MD, Doshi JA, et al. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011;32:101-114.

Visit www.BIOPATCH.com for Full Prescribing Information

Indication For UseBIOPATCH Disk containing Chlorhexidine Gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter related bloodstream infections (CRBSI’s), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.

ADDITIONAL INFORMATION:The dressing is not clinically tested for its activity to reduce local infections, catheter related bloodstream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI.

INDICATIONS:The Bard® GuardIVa® Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.

® Protective Disk with CHG

®

Clinical Trial ResultsA controlled, randomized, clinical trial consisting of 687 subjects with 1699 central venous or arterial catheter insertion sites was conducted at two centers.1

Results showed that the use of BIOPATCH Disk resulted in a statistically significant 44% reduction in the incidence of local infection (p≤0.0001).

Results also showed that the use of BIOPATCH Disk resulted in a statistically significant 60% reduction in the incidence of catheter-related blood stream infections (p≤0.026).

Results of this study also showed that use of BIOPATCH Disk resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p≤0.05). Patients randomized to the BIOPATCH Disk Treatment Group experienced no serious device-related adverse events.

1. Maki DG, Mermel L, Genthner D, Hua S, Chiacchierini RP: An evaluation of BIOPATCH® Antimicrobial Dressing compared to routine standard of care in the prevention of catheter-related blood stream infection. Ethicon, Inc. 2000.

Compare the Instructions for Use4,5

ACTIONS:In-vitro laboratory tests demonstrate that GuardIVa® Antimicrobial Hemostatic IV Dressing is effective against the microorganisms [listed in the IFU] and the log reduction data proves the level of antimicrobial effectiveness. The clinical utility of these results is unknown.

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