The document discusses technologies for antimicrobial dressings used at catheter sites to prevent catheter-related bloodstream infections. It describes several major products, including BioPatch with chlorhexidine gluconate which is the only dressing with an FDA indication for preventing these infections. Tegaderm CHG gel pad and GuardIVa haemostatic dressing also use CHG and have shown effectiveness in clinical studies. Kendall AMD uses polyhexamethylene biguanide and has extensive evidence of preventing infections from antibiotic-resistant bacteria. Algidex Ag uses ionic silver alginate and has broad-spectrum antimicrobial properties. These dressings provide antimicrobial barriers and absorb exudate at catheter sites for up to 7 days

1. Technologies for Antimicrobial Dressings at Catheter Site
Prevents microbial growth commonly associated with catheter-related bloodstream
infections (CRBSIs), and also acts as a physical barrier for external contaminations
50 patients die each day in US hospitals due to
bloodstream infections2,3
Catheter-related bloodstream infections are
preventable, often fatal and can significantly
impact hospital CMS reimbursement
Sources: 1. J&J 2. HAIs at Glance-CDC 2. Soufir L et.al., 1999

2. Major technologies available for dressings at catheter site are using chlorhexidine antimicrobial agent to
prevents microbial growth commonly associated with CRBSIs
Executive Summary
Chlorhexidine
Impregnated
Antimicrobial Disc
(2%)
Recommended by all
recent guidelines on
CRBSI prevention:
The CDC Guidelines
recommend the use of
CHG-impregnated sponge
dressing for temporary
short term catheters
when adherence to basic
preventative measures
has been unsuccessful
BioPatch: Only dressing with the US FDA-cleared indication for CRBSIs I Backed by
14-RCTs I 4x CHG release than GuardIVa I Better dressing profile than Tegaderm
o 44% reduction in local infection & 60% reduction in the incidence of CRBSIs
o Better microbial activity than GuardIVa & Aegis
GuradIVa: With haemostatic agent (m-doc™) I Better healing rate than BioPatch I
Not indicated for CRBSIs I Higher absorption rate than BioPatch & Kendall AMD
o 99.99% reduction in microbial count – for up to 7-days
o 7-times less blood loss compared to gauze dressings
Chlorhexidine Tegaderm: Powerful antimicrobial than BioPatch I Effective in 37 strains tested &
also in viral infection I 3x stronger adhesive strength I Low absorption than sponge
Additional Product Examples:
CHG Foam Disc: Medline Aegis Disc; CHG Transparent Dressing: IV Clear by Covalon
has been unsuccessful
Chlorhexidine
Transparent Gel Pad
(2%)
also in viral infection I 3x stronger adhesive strength I Low absorption than sponge
o Effectiveness is proven only by one single multicenter RCT (Timsit)
Polyhexamethylene
Biguanide (PHMB)
(0.5%)
Kendall AMD
o Effective protection against antibiotic resistant bacteria (MRSA & VRE)
o Antimicrobial effects within 30-minutes
o Protection against CRBSIs & resist bacterial colonization
o Clinically proven with extensive range of RCTs & case studies
Silver Impregnated
Antimicrobial Disc
Algidex Ag I Medline SilvaSorb I Silverlon Lifesaver
o Provides immediate & sustained antimicrobial activity against broad range of pathogens
o Low clinical evidence for infection prevention

3. 1. J&J – BioPatch® Protective Disk with CHG

4. BioPatch® protective disk with Chlorhexidine Gluconate (CHG) is the only dressing with the US FDA-cleared
indication for catheter-related bloodstream infection (CRBSI) prevention
J&J – BioPatch® Protective Disk1
BioPatch® proven in multiple meta-analyses and randomized
controlled trials to reduce risk of CRBSI3
BioPatch antimicrobial dressing is a hydrophilic polyurethane absorptive foam with CHG:
Ensure 360° protection around insertion site up to 7 days, with transparent film dressing
The foam material absorbs up to eight times its own weight in fluid, while the CHG
incorporated into the dressing inhibits bacterial growth under the dressing
Each disk’s time-released solution is activated by presence of moisture on skin, and has
been proven effective in the presence of organic matter including blood, sera and proteins
CHF Release
BioPatch Protective Dressing Disk Features:
o Only device with FDA-cleared indication to
#1 selling CHG dressing on the market with a category 1A - CDC recommendation (based on 2017 market share data)1
CRBSI - Catheter-related bloodstream infection; CHG – Chlorhexidine Gluconate
Sources: 1. Company Website 2. CHG Facts 3. BIOPATCH Clinical Studies
controlled trials to reduce risk of CRBSI
o Only device with FDA-cleared indication to
reduces risk of CRBSI & local infections
o Proprietary urethane composite material
designed to continuously release CHG
o 7-days of continuous antimicrobial protection
o Absorbs 8 times its own weight in fluids
o Eliminates frequent dressing changes
Approval: In 1993, BIOPATCH - the first CHG
sponge dressing was cleared by the US-FDA2
Price: $167.53 (10/pack)

5. BioPatch® protective disk with CHG is clinically proven in 14-Randomized Controlled Trials over 4500 adult
subjects to reduce the incidence of local infections and CRBSI
J&J – BioPatch® Protective Disk
Randomized controlled trial evaluating BioPatch and Conventional Dressing1
Swab test results: BioPatch vs. GuardIVa® and AEGIS2
CRBSI - Catheter-related bloodstream infection; CHG – Chlorhexidine Gluconate
Sources: 1. Maki D et.al., 2000 2. BIOPATCH Swab Test
Swab test results: BioPatch vs. GuardIVa® and AEGIS2
Based on the results of this in vitro study, BIOPATCH
Disk showed excellent antimicrobial activity against all
seven challenge organisms tested and was the only
dressing amongst the three tested that exhibited
microbicidal activity against all seven challenge
organisms.
The dressing showed sustained activity for up to seven
days against all seven challenge organisms tested

6. BIOPATCH® reported to be have better efficacy profile compared to GuardIVa, and compatibility over Tegaderm
as poor fluid management can result in adverse events in patients with Tegaderm gel pad
J&J – BIOPATCH® Protective Disk
Randomized controlled trial evaluating BIOPATCH vs. GuardIVa1
CRBSI - Catheter-related bloodstream infection; CHG – Chlorhexidine Gluconate
Sources: 1. BIOPATCH vs. GuardIVa 2. BIOPATCH vs. Tegaderm
Randomized controlled trial evaluating BIOPATCH vs. Tegaderm2
o Of the 70% disrupted dressings, nearly half were soiled due to
inability of the hydrogel to absorb all components of blood
o High rate of contact dermatitis is likely due to the hydrogel
component, which has been noted in a separate observational
report on pediatric and elderly patients

7. 2. 3M Healthcare - Tegaderm™ CHG Gel Pad
Tegaderm Application Sites

8. Tegaderm™ CHG dressings enhance I.V. site protection efforts by integrating the antimicrobial power of
chlorhexidine gluconate (CHG), with the transparent film for continuous observation
3M Healthcare - Tegaderm™ CHG Gel Pad1,2
Antimicrobial Protection: Integrated 2% CHG
gel pad provides protection for up to 7-days
Absorbs perspiration, exudate and blood
without compromising antimicrobial activity
or site visibility
Tegaderm CHG Dressings are Proven to2,3
Clinically proven to reduce CRBSI in patients with central venous / arterial
catheters by 60% (randomized, multi-arm, controlled trial; N=1879)8
Clinically proven to reduce skin and catheter colonisation in patients with
central venous and arterial catheters by 61%, and major catheter related
infection by 67%
Offers the same level of antimicrobial activity up to seven days
Immediately kill skin flora, and provides a larger area of protection
Tegaderm film is a selective barrier
CRBSI: Catheter-related bloodstream infection
Sources: 1. Company Website 2. Tegaderm Brochure 3. Tegaderm Clinical Results 4. Vitalitymedical.com 5. NICE 6. US-FDA 7. Businesswire 8. Timsit et.al., 2012
Securement: Reinforced border and notch
provides catheter securement
Site Visibility: Transparent film and gel pad
allow continuous site observation
High Breathable Transparent Film: Promotes
moisture evaporation
Tegaderm film is a selective barrier
allows for effective oxygen - vapour
exchange while helping protect against
contaminants including those most
commonly associated with CRBSI2
Tegaderm CHG Dressing offers adhesives build
strength over the first 24-hrs, and withstood
3-times the pull force of the leading flat film
dressing after 48-hrs 4
Approved – CE Marked as a Class-III (Apr-2009)5 I US FDA – 510(K) 6,7
Unit Price: UK - £19 I USA - $20.53

9. Tegaderm™ CHG dressing showed powerful microbial activity compared to BioPatch, and offers long-term
cutaneous floral suppression and were well tolerated in healthy adult subjects
3M Healthcare - Tegaderm™ CHG Gel Pad
Tegaderm CHG Dressing is clinically evaluated more effective than BIOPATCH® Protective Disk
Reduces Skin Flora1 Suppresses Regrowth1
Maintains Low Skin Organism Count2
Sources: 1. Dennis et.al., 2008 2. Bashir et.al., 2010 3. Tegaderm Brochure 4. In-Vitro Antimicrobial Test
In vivo time kill of flora on unprepped skin with
two CHG dressings on healthy adult subjects
(P=0.008)
Suppression of regrowth of prepped
subclavian sites with two CHG dressings on
healthy adult subjects (P=0.0003)
Pairwise testing done against Tegaderm
using paired t-test with Holm stepwise
adjustment for multiple comparisons
Effective against Viral Infection3
In vitro testing shows that the transparent
film of Tegaderm CHG dressing provides a
viral barrier from viruses 27 nm in diameter
or larger while the dressing remains intact
without leakage
Broad-spectrum Antimicrobial: Effective against all 37 strains tested4
Antimicrobial activity of the Tegaderm CHG dressing was tested against a
panel of 37 microorganisms, comprised of 21 gram positive and 14 gram
negative bacteria, and 2 yeasts: Effective against gram-negative
staphylococci and Staphylococcus aureus , including those methicillin-
resistant strains – and vancomycin resistant enterococci

10. 3. BARD – GuardIVa® Haemostatic IV Dressing
GuardIVa Dressing was found to be effective at
inhibiting bacterial growth on contacting surface
for all microorganisms tested: shown to effective
at 24-hrs and sustained for 7-days1
Sources: 1. GuardIVa White Paper

11. GuardIVa® is a hydrophilic polyurethane sponge dressing impregnated with the broad spectrum
antimicrobial agent CHG and a proprietary haemostatic agent micro-dispersed oxidized cellulose (m-doc™)
BARD – GuardIVa® Haemostatic IV Dressing1
GuardIVa® is also the only IV site dressing indicated to control surface bleeding from percutaneous access sites1,2
o Flexible sponge disk that absorbs exudate from catheters
o CHG having broad-spectrum antimicrobial and antifungal activity
o Hemostatic agent - controls surface bleeding from percutaneous catheter sites
o Works continuously for up to 7 days; Absorbs up to eight times its weight in liquid
Hemostasis Efficacy2: An in vivo animal test showed that wounds treated with the
GuardIVa® significantly reduced time to hemostasis and had up to 7-times less blood loss
compared to gauze dressings
CHG: Chlorhexidine gluconate
Sources: 1. Company Website 2. GuardIVa White Paper
Healing Efficacy2
An in vivo animal study showed that wounds
treated with GuardIVa healed at a rate
comparable to untreated wounds, unlike BioPatch
Antimicrobial Efficacy2
Demonstrated in vitro antimicrobial efficacy against test organisms
known to cause CRBSIs
In vitro testing demonstrated sustained antimicrobial efficacy for up
to 7 days: Greater than 4 log (99.99%) reduction in microbial count
was observed for all test organisms

12. GuardIVa® haemostatic dressing has not been clinically tested for its ability to reduce catheter-related
bloodstream infections (CRBSIs)
BARD – GuardIVa® Haemostatic IV Dressing
Bacteriocidal vs. Bacteriostatic Efficacy1
Both GuardIVa and BIOPATCH dressing were found to
be bactericidal against five of the microorganisms and
bacteriostatic against three of the microorganisms
Suppression of skin microflora re-growth following skin
antisepsis1
GuardIVa dressing showed significantly lower re-growth of
skin flora compared to the control at both Day-7 & Day-10
CHG: Chlorhexidine gluconate
Sources: 1. GuardIVa White Paper Study 2. Angela Skelton et. al.,
Alginex AG BIOPATCH Kendall AMD GuardIVa

13. 4. Cardinal Health/ Covidien Inc. - Kendall™ AMD Antimicrobial Foam Disc

14. The strong protection of Kendall™ AMD antimicrobial dressings is available as a foam disc with 0.5%
Polyhexamethylene Biguanide (PHMB), reported to be effective against antibiotic resistant bacteria
Cardinal Health/ Covidien Inc. - Kendall™ AMD Antimicrobial Foam Disc1,2
Features1,3
o Effective for up to 7-days
o Resist bacterial colonization and bacterial penetration through the dressing
o Limits cross-contamination: Ideal for use around external fixation devices
This product contain 0.5% PHMB, a bacteria-killing polymer that virtually eliminates bacterial penetration through and
growth within the dressings. And proven to be effective against both gram + and gram – bacteria as well as yeast and fungi
Highly safe and broad-spectrum antimicrobial, which has been in use for over 75 years with no evidence of resistance
MRSA: Methicillin-resistant Staphylococcus aureus; VRE: Vancomycin-resistant Enterococci
Sources: 1. Company Website 2. Gavecelt.it 3. Kendall Brochure
o Protects insertion sites from harmful bacteria, such as MRSA and VRE
o Helps protect against catheter-related bloodstream infections (CRBSIs)
o Promotes a healthy insertion environment by simultaneously managing moisture and
bacteria in the dressing
PHMB – Mode of Action3
PHMB binds to the cell membranes of micro-organisms causing holes to form; the cells
subsequently leak, causing them to collapse and die within 30 minutes – this will occur
in both wet and dry conditions
PHMB also impacts bacterial metabolism, starving cells of energy
PHMB

15. Clinically proven with extensive range of RCTs and case studies1,2
Cardinal Health - Kendall™ AMD Antimicrobial Foam Disc Dressings
Sources: 1. Clinical Studies 2. Clinical Studies-2

16. 5. DeRoyal Industries Inc. - Algidex Ag® IV Patch

17. Algidex Ag® has uniquely formulated with a combination of Ionic Silver Alginate and Maltodextrin to
provide immediate and sustained antimicrobial barrier against a broad spectrum of pathogens
DeRoyal Industries Inc. - Algidex Ag® IV Patch1,2
Algidex Ag® is available in form of sterile patch of polyurethane foam coated with a silver alginate and maltodextrin matrix:
Ideal dressing for intravenous catheters, tube sites, or external fixator pin sites
Features
o Antimicrobial barrier remains effective for up to 7-days
o Reduce bacterial colonization associated with catheter related infections
o Absorbs moisture around the catheter insertion site
o No adherence to the site upon removal
o Does NOT require activation
Each pack: US$11.28
510(K) Approval – Apr 2018
MRSA: Methicillin-resistant Staphylococcus aureus;
Sources: 1. Company Website 2. Vadsupplies.com 3. Microbial Study
o Does NOT require activation
In vitro Study: Broad-spectrum antimicrobial activity, including MRSA, S. aureus, E. coli and Pseudomonas aeruginosa3
Clinical Evidence: Safety evaluation of Algidex™ dressing in very low birth weight infants (NCT00593684)

18. 2.

19. Methodology
Technologies for Antimicrobial Dressings at Catheter Site
Objective: To identify major players having technologies for antimicrobial dressings for catheter sites
Inclusion Criteria
o Technologies / antimicrobial dressings intended for CRBSIs & resist catheter colonization
o Major players into this segment
Inclusion Criteria
o Catheters with impregnated antimicrobial agent
o Conventional gauze dressings, bandage
Time Period: No time restriction (open)
Time Period: No time restriction (open)
Geography: Global
Sources: Google search, CT.gov, Medical device@FDA, Pubmed, Google scholar, Company website
Time Spent: 16-18 hours