Brochura UrgoTul AG

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THE JELLIFYING SILVER CONTACT LAYER

PROVEN TO FACILITATE WOUND PROGRESS

Matrix
ing
r
Resto

PATIENTS WITH LIGHT TO MODERATELY EXUDATIVE PARTIAL AND FULL THICKNESS


WOUNDS, INCLUDING DIABETIC ULCERS, FIRST AND SECOND DEGREE BURNS,
DECUBITUS ULCERS, VENOUS STASIS ULCERS, AND GRAFT AND DONOR SITES
THE JELLIFYING SILVER CONTACT LAYER PROVEN TO
FACILITATE WOUND PROGRESS

Lipophilic substances
Matrix
ing
Jellifying particles
r
Resto

Silver sulphate

Clinically proven to facilitate wound progress with reduced signs of local infection over neutral dressings(2)

Shown to be effective against bacteria most frequently associated with wound infections: Staphylococcuss
aureus, Streptococcuss pyogenes, Pseudomonas aeruginosa (pyocyanic bacillus), MRSA, Enterococcus
faecalis VRE, Escherichia coli and Candida albicans(1)

Sustained antibacterial activity for up to 7 days (in vitro studies)(1)

Atraumatic and pain-free due to the jellifying TLC-Ag matrix

HAS PROVEN ANTIBACTERIAL ACTIVITY AGAINST BACTERIA


FREQUENTLY ASSOCIATED WITH WOUND INFECTIONS FOR UP TO 7 DAYS, IN VITRO(1)

MRSA S. pyogenes Pseudomonas aeruginos


Methicilin-resistant Staphylococcus
MRSA aureus MRSA S. pyogenes S. pyogenes
Methicilin-resistant Staphylococcus aureus
Methicilin-resistant Staphylococcus aureus 11,00 11,00

10,00 10,00 10,00 10,00 10,00 10,00

9,00 9,00 9,00 9,00 9,00 9,00

8,00 8,00 8,00 8,00 8,00 8,00

7,00 7,00 7,00 7,00 7,00 7,00


Log (CFU/ml)

Log (CFU/ml)

Log (CFU/ml)

Log (CFU/ml)
Log (CFU/ml)

Log (CFU/ml)

6,00 6,00 6,00 6,00 6,00 6,00

5,00 5,00 5,00 5,00 5,00 5,00

4,00 4,00 4,00 4,00 4,00 4,00

3,00 3,00 3,00 3,00 3,00 3,00

2,00 2,00 2,00 2,00 2,00 2,00


MRSA S. pyogenes
1,00 1,00 Methicilin-resistantMRSA
1,00 Staphylococcus
1,00 aureus 1,00 S. pyogenes
1,00
Methicilin-resistant Staphylococcus aureus
0,00 0,00 10,00 0,00 0,00 10,00 0,00 0,00
Days Days Days Days
10,00 10,00
D0 D1 D2 D3 D4
D0 D1 D2 D7 D3 D4 D7
9,00 D0 D1 D2 D3 D0 D1 D2 D7D3 D7
9,00 D0 D1 D2 D3 D0D5 D7
D1 D
9,00 9,00
8,00 8,00
Pseudomonas aeruginosa
Pseudomonas aeruginosa Pseudomonas aeruginosa
8,00 8,00
7,00 7,00
pyogenes S. pyogenes Candida albicans
(CFU/ml)

7,00
(CFU/ml)

7,00 Candida albicans


11,00 11,00 Candida albicans 6,00
(CFU/ml)

6,00
(CFU/ml)

6,00 6,00
0,00 10,00 10,00 5,00 10,00 10,00 5,00
5,00 5,00
9,00 9,00 9,00 4,00
Log

9,00 4,00 9,00


Log

4,00
Log

4,00
Log

8,00 8,00 8,00 3,00 8,00 8,00 3,00


3,00 3,00
7,00 7,00 7,00 2,00 7,00 7,00 2,00
Log (CFU/ml)
Log (CFU/ml)

2,00
Log (CFU/ml)
Log (CFU/ml)

2,00
6,00 6,00 6,00 1,00 6,00 6,00 1,00
1,00 1,00
5,00 5,00 5,00 0,00 5,00 5,00 0,00
Days 0,00
0,00
4,00 4,00 4,00 D04,00 D1 D2 D3 D4 4,00 D7 Days D0 D1 D2 D3 D7
D0 D1 D2 D3 D4 D7 D0 D1 D2 D3 D7
3,00 3,00 3,00 3,00 3,00

2,00 2,00 2,00 2,00 2,00

1,00 1,00 1,00


1,00 Control
1,00(TLC)
0,00 0,00 0,00 Antibacterial
0,00 (TLC-Ag)
Days 0,00
Days Days Days Days
Days
D0 D1 D2
D7 D3 D7 D0 D1 D2 D3 D5D0 D7 D1 D2 D3 D5 D7 D0 D1 D2 D3 D0 D1 D2
D7 D3 D7
THE JELLIFYING SILVER CONTACT LAYER PROVEN TO
FACILITATE WOUND PROGRESS

IS CLINICALLY PROVEN TO FACILITATE WOUND PROGRESS WITH


REDUCED SIGNS OF LOCAL INFECTION OVER NEUTRAL DRESSINGS(2)

STUDY DESIGN:
• Randomized controlled trial, multicenters
• 102 patient RCT, 2 groups (sequential group: UrgoTul Ag/UrgoTul; neutral group: UrgoTul)
• Leg ulcers presenting signs suggesting heavy bacteria load

A significantly lower clinical score* with the sequential TLC-Ag group

Clinical score
Sequential Neutral TLC A very good safety profile of the TLC-Ag dressing
TLC-Ag group group
The TLC-Ag dressing did not induce any increase
D0 3.84 3.84 in blood silver levels in the patients checked
(blood samples taken at D0, W4 and W8)
W4 1.25 2.31

W8 1.43 2.31 (p=0.0001)

-47.9% wound surface reduction with the sequential TLC-Ag group (p=0.036)

Efficacy endpoint reduction in wound surface area


0

TLC -5.6%
- 10
% surface area reduction

TLC-Ag
- 20

- 30

- 40
TLC -47.9%

- 50 Week of treatment
W1 W2 W3 W4 W5 W6 W7 W8

*defined by the presence of 5 clinical signs: peri-wound skin erythema, oedema, pain between two dressing changes,
malodorous wound, high level of exudate.
THE JELLIFYING SILVER CONTACT LAYER PROVEN
TO FACILITATE WOUND PROGRESS

21 month year old patient presenting a burn 58 year old female patient presenting a 3rd degree
burn with carbonisation

D0 D2 D15 Control visit D0 D1 D10 D36

45 year old male patient presenting a traumatic wound

D0 D10 D15 D20

• Recommended dressing change every 1 to 3 days


• Indicated for patients with light to moderately exudative partial and full thickness wounds, including diabetic
ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites

Urgo Medical North America 801-LT003, 04/2021


ing
Matrix
ing
Matrix Can Can be used
Can Can be cut under
r

r
Resto

Resto

be cut be meshed compression


bandage

Size Size Size Size


No. per box Code No. per box Code
(inch) (cm) (inch) (cm)
4x5 10 x 12 10 509341 4x4 10 x 10
18-25 cm 10 cm
25-32 509345
18-25 cm 25-32 cm
6x8 15 x 20 10 509342 6x8 15 x 20 10 509346
8 x 12 20 x 40 5 553228

18-25 cm 25-32 cm 18-25 cm 25-32 cm


18-25 cm
18-25 cm 25-32 cm25-32 cm
References: 1. UrgoTul Ag data on file. 2. Lazareth I., Meaume S., Sigal-Grinberg M-L, et al. The Role of a Silver Releasing Lipido-colloid Contact Layer in Venous Leg Ulcers Presenting
Inflammatory Signs Suggesting Heavy Bacterial Colonization: Results of a Randomized Controlled Study. WOUNDS 2008;20(6):158–166.
Prior to use, be sure and read the entire Instructions for Use package insert supplied with the product for Device Intended Use, Description, Contraindications, Warnings, Precautions,
Adverse Events, and Instructions for Use. Caution: Federal laws restrict this device to sale or on the order of a physican or licensed healthcare professional.

URGO Medical North America, LLC. 3801 Hulen St. Ste 251, Fort Worth, TX 76107.
To order in the US, call 1-855-888-8273
To order in Canada, call 1-888-446-4143
www.urgomedical.us

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