Overview

PROMOGRAN™ matrix is a topically applied interactive wound therapy. The product is a sterile, freeze dried composite of oxidised regenerated cellulose (ORC) and collagen.

In the presence of exudate the PROMOGRAN™ matrix transforms into a soft and conformable, biodegradable gel; this allows contact with all areas of the wound. PROMOGRAN™ matrix modulates and re-balances the wound environment by the unique combination of binding and inactivation of proteases with binding and protection of naturally occurring growth factors.

A key difference between chronic and normal wound environments:^{95, 96, 97}

• The persisting inflammatory phase in chronic wounds contributes to exudate with high concentrations of proteases, such as of matrix metalloproteases (MMPs)⁸¹
• Excess MMPs result in degradation extracellular matrix proteins
  The result: Delayed wound healing.

Ulcer development

Mode of Action - A Powerful Combination

PROMOGRAN™ Matrix is the first and only matrix that combines oxidized regenerated cellulose (ORC) and collagen - a combination proven to promote an optimal healing environment. PROMOGRAN™ matrix modulates and re-balances the wound environment by the unique combination of binding and inactivation of proteases with binding and protection of naturally occurring growth factors against degradation by these excess proteases.

Modes of action of PROMOGRAN™ Dressing

1. MMP binding and inactivation^{82, 83}, through this effect:

• reduce proteolytic destruction of the extra-cellular Matrix,
• reduce proteolytic degradation of molecules acting positively in wound healing.

2. Endogenous growth-factor binding, protection and release⁸⁴
3. Proven effect on chemotaxis and cell proliferation^{83, 85, 86}

• collagen: effect on chemotaxis
• oxydised regenerated cellulose: effect on chemotaxis and cell proliferation

4. Absorption of free radicals⁸⁴
5. Haemostasis of bleeding wounds⁸³

Proven, powerful performance:

Proven to reduce wound surface area…⁸¹

Proven performance in a prospective multi-center study including 73 patients with venous leg ulcers

1. Statistically significant difference in favor of PROMOGRAN™ Dressing vs control in percentage of surface area reduction:

• PROMOGRAN™ Dressing average 54.4% reduction vs control (average 36.5% reduction), a 49% improvement relative to control

2. Non-significant difference in favor of PROMOGRAN™ Dressing in complete wound healing:

• 41% vs 31% (P=0.373)

Proven to reduce MMP levels

The matrix is proven to bind MMPs in the dressing⁸¹, and promote a moist wound healing environment. ORC/collagen combination binds more MMPs in the dressing than ORC or collagen alone.⁸²

More than simple collagen dressings…⁸¹

Only PROMOGRAN™ Matrix offers the combination of ORC/Collagen that creates a powerful synergy to bind and inactivate more harmful MMPs in the dressing.^{81, 82}

More protease binding and inactivation in the dressing⁸²

Proven to bind and protect endogenous growth factors

PROMOGRAN™ Matrix binds and protects naturally occurring growth factors against degradation by excess proteases. These naturally occurring, protected, growth factors are released back into the wound, while the detrimental proteases remain inactive upon bio-degradation of the PROMOGRAN™ matrix. Only PROMOGRAN™ as a combination of collagen and ORC binds and protects growth factors more efficiently than its two individual components^{82, 83}

Protection of PDGF from enzyme degradation by incubation with PROMOGRAN™

# presented as PDGF (plateled derived growth factor) activity

Proven effect on chemotaxis and cell proliferation

Collagen is naturally broken down into small peptides, some of which have been shown to stimulate chemotaxis in vitro^{85, 86}. Also ORC has been shown to stimulate fibroblast chemotaxis and proliferation.

All collagen-based dressings are NOT the same.

Only PROMOGRAN™ Matrix combines oxidized regenerated cellulose (ORC) and collagen-a proprietary combination proven to:

• Overcome the negative effects of chronic wound fluid on cell growth
• Promote cell growth more effectively than simple collagen dressings.⁸¹

The following three graphs compare the amount of cellular growth in chronic wound fluid alone versus chronic wound fluid which was incubated with various collagen dressings.⁸¹

More Fibroblast Cell Proliferation

PROMOGRAN™ Matrix promoted greater fibroblast cell growth in chronic wound fluid than simple collagen dressings.⁸¹

More Endothelial Cell Proliferation

Endothelial cell growth in chronic wound fluid was greater with PROMOGRAN™ Matrix vs simple collagen dressings.⁸¹

More Keratinocyte Cell Proliferation

Greater keratinocyte cell proliferation in chronic wound fluid was observed with PROMOGRAN™ Matrix vs simple collagen dressings.⁸¹

Biostep and Colactive are trademarks of Smith & Nephew
Puracol is a trademarks of Medline Industries
Aquacel is a trademark of ConvaTec
Oasis is a trademark of Cook Biotech Inc., distributed by Healthpoint
Skin Temp is a trademark of Biocore Medical Technologies, USA

Indications

PROMOGRAN™ matrix is indicated for the management of all wounds healing by secondary intent which are clear of necrotic tissue, including:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular aetiologies
• Traumatic and surgical wounds

PROMOGRAN™ matrix has demonstrated haemostatic properties.
PROMOGRAN™ matrix can be used under compression therapy.

Contraindications

PROMOGRAN™ matrix is contraindicated in patients with known hypersensitivity to the components of this product, i.e. ORC and Collagen. Discontinue use if signs of sensitivity appear.

Warnings

If infection is suspected during treatment, an appropriate antimicrobial dressing such as ACTISORB™ Activated Charcoal Dressing with Silver or systemic therapy should be used.

No safety issues have been raised in pressure ulcers, venous ulcers and diabetic ulcers to date.

How to use

† Choose an appropriate secondary dressing depending on level of exudate.

Package insert

Product description

PROMOGRAN™ matrix is a topically applied interactive wound therapy. The product is a sterile, freeze dried composite of oxidised regenerated cellulose (ORC) and collagen. In the presence of exudate the PROMOGRAN™ matrix transforms into a soft and conformable, biodegradable gel; this allows contact with all areas of the wound. Saline or Ringer’s solution should be used to hydrate PROMOGRAN™ matrix on dry wounds.

PROMOGRAN™ matrix modulates and re-balances the wound environment by the unique combination of:

1. Binding and inactivation of proteases (i.e. matrix metallo proteases, elastase and plasmin) which have been shown to be detrimental in excess in chronic wounds.
2. Binding and protection of naturally occurring growth factors against degradation by these excess proteases.

These naturally occurring, protected, growth factors are released back into the wound, while the detrimental proteases remain inactive upon bio-degradation of the PROMOGRAN™ matrix.

PROMOGRAN™ matrix has demonstrated free radical scavenging properties.

Indications for use

PROMOGRAN™ matrix is indicated for the management of all wounds healing by secondary intent which are clear of necrotic tissue, including:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular aetiologies
• Traumatic and surgical wounds

PROMOGRAN™ matrix has demonstrated haemostatic properties.
PROMOGRAN™ matrix can be used under compression therapy.

Contraindications

PROMOGRAN™ matrix is contraindicated in patients with known hypersensitivity to the components of this product, i.e. ORC and Collagen. Discontinue use if signs of sensitivity appear.

Warnings

If infection is suspected during treatment, an appropriate antimicrobial dressing such as ACTISORB™ Activated Charcoal Dressing with Silver or systemic therapy should be used.

No safety issues have been raised in pressure ulcers, venous ulcers and diabetic ulcers to date.

DIRECTIONS FOR USE

Site Preparation

Before treatment, dry necrotic tissue must first be removed by surgical, enzymatic or autolytic debridement.

Application

• For optimal effect, apply PROMOGRAN™ matrix directly to the whole wound bed.
• For a wound with low or no exudate apply PROMOGRAN™ matrix and hydrate with saline or Ringer’s solution. This will initiate the gel forming process.
• After hydration the PROMOGRAN™ gel will intimately contact the wound.
• The biodegradable gel is naturally absorbed over time.
• PROMOGRAN™ matrix must be covered with either gauze, a non-adhering or a hydropolymer dressing in order to maintain a moist wound healing environment.
• After initial treatment, retreat the wound with PROMOGRAN™ matrix up to every 72 hours depending upon the amount of exudate. It is not necessary to remove any residual PROMOGRAN™ matrix.

Do not use if individual pack is damaged/opened.
The use by date of this product is printed on the packaging.

Leaflet prepared: November 2002

Evidence

Coming soon.

Order Information

PROMOGRAN™ Protease Modulating Matrix

Code	Description	Packaging	Eaches
M772028	28 cm squared	10 eaches/box	10
M772123	123 cm squared	10 eaches/box	10