q Introducing Wound Dressing Incorporated with
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Introducing
Wound Dressing
Incorporated with
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
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
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
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
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
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
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 ( )
Antibacterial action of competitive silver dressings
Wound Dressing
1
2
3
4
5
6
7
8
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”
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
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
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)
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
13
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
1
2
3
4
5
6
7
8
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
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
6
7
8
9
10
11
12
13
14
15 30 45 60 90 120
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
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
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
For more information:Rod SzarkaVP, MarketingSuite 4000, 10230 Jasper AvenueEdmonton, Alberta, T5J 4P6(780) [email protected]