Exsalt SD7 Wound Dressing Presentation

19
q Introducing Wound Dressing Incorporated with

Transcript of Exsalt SD7 Wound Dressing Presentation

Page 1: Exsalt SD7 Wound Dressing Presentation

q

Introducing

Wound Dressing

Incorporated with

Page 2: Exsalt SD7 Wound Dressing Presentation

Exciton’s exsalt™ SD7 Wound Dressing utilizes the Company’s patented silver oxysalts technology:

• Broad spectrum antimicrobial action

• Excellent biocompatibility

• slow pH shift

• silver in the +1, +2 and +3 valence states

Wound Dressing

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Higher Valence State Silver

More silver to the site in an active form

Potency

Less impairment to wound healing

Minimal risk of bacteria resistance

Ag+1 Ag+2 Ag+3 Toxicity

Resistance

Silver oxysalts on substrate

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Coating Technology

Ultra-thin silver film layerdeposited on substrate

Multiple species and oxidation/valence states enhance antimicrobial

properties

AgO

Ag2SO4

Ag7O8NO3 Ag3O4

Ag2O3

Efficient “dip-rinse-dry” process is ideal for coating a variety of wound care materials in high volumes

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Product Description:

• Consists of 2 outer layers of High Density Polyethylene (HDPE)

• With an inner layer of absorbent polyester

• All layers are coated with silver oxysalts

Wound Dressing

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Indications:

• Partial and full thickness wounds

• Decubitus ulcers

• Venous stasis ulcers

• Diabetic ulcers

• First and second degree burns

• Grafts and donor sites

• May be used over debrided and grafted wounds

Wound Dressing

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Wound Dressing

Silver Content of Dressings*Proprietary Name Ag content (mg/100cm2)Silverlon® 546Acticoat® 7 161Calgitrol Ag™ 141Contreet® Foam 85

exsaltTM SD7 40Contreet® Hydrocolloid 32Aquacel Ag® 8.3SilvaSorb® 5.3Actisorb® Silver 220 2.7

Optimal Silver Concentration

* data available

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Wound Dressing

Exsalt SD7

Acticoat

Mepilex Ag

Aquacel Ag

Silverlon

Not all Silvers are the same – XRD Diffraction Analysis

Silver oxysalt Ag7O8NO3 ( )

Silver oxide Ag2O ( )

Metallic silver, Ag0 ( )

Silver chloride ( )

Silver Sulfate ( )

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Antibacterial action of competitive silver dressings

Wound Dressing

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Log

Red

uctio

n (1

0X )

Staphylococcus aureus (ATCC #6538)

“Fail”

exsaltTM SD7 (Exciton)

Acticoat 7 (Smith & Nephew)

Silverlon (Argentum Medical)

Allevyn Ag (Smith & Nephew)

Medifoam S (Biopol – Korea)

Mepilex Ag (Mölnlycke)

Aquacel Ag (Convatec)Silver Dressings (4 hr. exposure; 106 starting inoculum)

“Pass”

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Wound Dressing

7 Consecutive Day Challenge with 106 CFU/mL of Inoculum

FCS = fetal calf serum; MRD = Maximum Recovery Diluent; NDP = neutralize, dilute, and plate; X = not applicable for that Day Test Set* Time 0 is the preparation of reaction test tubes** Each Test Set consists of three replicates each plated in triplicate

Inoculation, Neutralization, Dilution and Plating Scheme of 7 Day Challenge of exsaltTM SD7 Wound Dressings

Time Test Set** Day 1 Test Set Day 3 Test Set Day 5 Test Set Day 7

Time 0* 1 mL FCS:MRD1 mL FCS:MRD

0.7 mL FCS:MRD1 mL FCS:MRD

0.5 mL FCS:MRD1 mL FCS:MRD

0.3 mL FCS:MRDTime 0 Inoculation 1 mL inoculum 0.1 mL inoculum 0.1 mL inoculum 0.1 mL inoculum

Day 1(24 hrs)

NDP 0.1 mL inoculum 0.1 mL inoculum 0.1 mL inoculum

Day 2(48 hrs)

X 0.1 mL inoculum 0.1 mL inoculum 0.1 mL inoculum

Day 3(72 hrs)

X NDP 0.1 mL inoculum 0.1 mL inoculum

Day 4(96 hrs)

X X 0.1 mL inoculum 0.1 mL inoculum

Day 5(120 hrs)

X X NDP 0.1 mL inoculum

Day 6(144 hrs)

X X X 0.1 mL inoculum

Day 7(168 hrs)

X X X NDP

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Wound Dressing

Four Log Reduction Achieved over 7 days

012345678

0 1 2 3 4 5 6 7

Log

Valu

e(X

10)

Day

Dressings challenged daily with 106 CFU/mL; samples taken Day 1, 3, 5 & 7Pseudomonas aeruginosa (ATCC #9027)

Uncoated Control

exsaltTM SD7 Dressing

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Wound Dressing

012345678

0 1 2 3 4 5 6 7

Log

Valu

e(X

10)

Day

Dressings challenged daily with 106 CFU/mL; samples taken Day 1, 3, 5 & 7

Uncoated Control

exsaltTM SD7 Dressing

Four Log Reduction Achieved over 7 days

Staphylococcus aureus (ATCC #6538)

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Wound Dressing

Feedback from Clinical Evaluations

• Dressing is appropriate for a variety of wound indications

• No pain caused by dressing (vs. Acticoat causes pain)

• Significant reduction of wound odour reported

• Effective moisture management

• No staining

• Decision to switch to exsalt™ SD7 influenced by lower price

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Broad spectrum antimicrobial efficacy

(organisms tested to date):

Gram Negative•Acinetobacter baumannii•Escherichia coli•Pseudomonas aeruginosa•Klebsiella pneumoniae

Gram Positive•Corynebacterium striatum•Enterococcus faecalis•Enterococcus faecalis VRE•Staphylococcus epidermidis•Staphylococcus aureus

Yeast/fungi•Candida albicans•Aspergillus niger

Equivalent performance using 75% less silver

Wound Dressing

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Log

Bac

teria

l Cou

nt (1

0X)

Enterococcus faecalis

4 Log Reduction

3 days

exsaltTM SD7

Acticoat 7

0 hours 1 hr 7 days

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Slower pH shift and potentially less pain

Acticoat 7 (1.6 mg Ag/cm2)

exSALTTM SD7 (0.4mg Ag/cm2)

Equivalent to Acticoat®

compatibility & efficacy

Wound Dressing

Time in minutes

pH le

vel

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15 30 45 60 90 120

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Porcine Healing Model

Day 0

Day 9

Wound Dressing

• No negative impact on wound healing

• Data sufficient to warrant a human clinical trial now in progress at University of Alberta Hospital in Canada

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Directions for Use:

• Remove exsalt™ SD7 wound dressing from package.

• Apply the dressing dry or moist and cut to shape as necessary.

• Apply the dressing to the wound surface and cover with a secondary dressing as appropriate for the degree of exudate. Secure with surgical tape or a bandage as appropriate.

• Examine the dressing daily and change depending on the amount of exudate and the condition of the wound ensuring that a moist environment is maintained.

• If the dressing adheres to the wound, moisten or soak the dressing prior to removal.

• Avoid forceful removal and disruption of the healing wound.

Wound Dressing

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Available Sizes:

• The dressing can be cut to size

Wound Dressing

Product code Size Dressing per Carton

Carton per Case HCPCS Code

PN-09-0004 2” x 2”(5cm x 5cm) 5 20 A6251

PN-09-0005 4” x 5”(10cm x 12.5cm) 5 6 A6252

PN-09-0007 6” x 6”(15cm x 15cm) 5 4 A6252

PN-09-0015 8” x16”(20cm x 40cm) 5 20 A6253

PN-09-0017 16” x 16”(40cm x 40cm) 5 10 A6253

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For more information:Rod SzarkaVP, MarketingSuite 4000, 10230 Jasper AvenueEdmonton, Alberta, T5J 4P6(780) [email protected]