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.

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. This environment is conducive to granulation tissue formation, epithelialization and rapid wound healing.

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:

• 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

Colactive is a trademark of Smith & Nephew
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

PROMOGRAN™ Dressing is an advanced wound care device comprised of a sterile, freeze dried composite of 45% oxidized regenerated cellulose (ORC) and 55% collagen. In the presence of exudate the PROMOGRAN™ Dressing transforms into a soft, conformable, biodegradable gel, and thus allows contact with all areas of the wound. PROMOGRAN™ Dressing maintains a physiologically moist microenvironment at the wound surface. This environment is conducive to granulation tissue formation, epithelialization and rapid wound healing. PROMOGRAN™ Dressing is a primary dressing that can be cut to fit wound with sterile scissors and used in combination with either a semi-occlusive or non-occlusive secondary dressing. Prior to application in dry wounds saline solution should be used to hydrate PROMOGRAN™ Dressing.

Indications for use

PROMOGRAN™ Dressing is intended for the management of exuding wounds including:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular etiologies
• Full-thickness & partial thickness wounds
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds

PROMOGRAN™ Dressing may be used under compression therapy with healthcare professional supervision.

Precautions

PROMOGRAN™ Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

Contraindications

PROMOGRAN™ Dressing is not indicated for wounds with active vasculitis, third-degree burns, or patients with known sensitivity to ORC or collagen.

DIRECTIONS FOR USE

Wound Bed Preparation

Prepare wound bed per your standard wound care protocol and debride when necessary. Wound bed should be clear of any visual signs of infection.

Application

• For optimal effect, apply PROMOGRAN™ Dressing directly to the whole wound bed.
• For a wound with low or no exudate apply PROMOGRAN™ Dressing and hydrate with saline solution. This will initiate the transformation of the PROMOGRAN™ Dressing into a gel matrix.
• After hydration, through exposure to wound exudate or saline, the PROMOGRAN™ gel matrix will intimately come into contact with the wound surface.
• The biodegradable PROMOGRAN™ gel matrix is naturally absorbed into the body over time.
• In order to maintain a moist wound healing environment PROMOGRAN™ Dressing must be covered with a semi-occlusive dressing (e.g. BIOCLUSIVE™ Transparent Dressing, TIELLE™ Hydropolymer Dressing or TIELLE™ Plus Hydropolymer Dressing) or a non-occlusive secondary dressing (e.g. NU GAUZE™ General-Use Sponge or SURGIPAD™ Combined Dressing) and fixed to the skin with a nonirritating tape (e.g. DERMICEL™ Hypo-Allergenic Cloth Tape).
• After initial application, reapply PROMOGRAN™ Dressing to the wound up to every 72 hours depending upon the amount of exudate. It is not necessary to remove any residual PROMOGRAN™ Dressing during dressing changes.

Adverse Reactions

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

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

RX only Caution: Federal [U.S.] Law restricts this device to sale by or on the order of a physician [or properly licensed professional]. This caution is not applicable outside the U.S.

Leaflet prepared: December 2001

Evidence

Some effects of a topical collagen-based matrix on the microcirculation and wound healing in patients with chronic venous leg ulcers: preliminary observations.

Wollina, U., Schmidt, W.D., Kronert, C., Nelkamp, C., Scheibe, A., Fassler, D. Int. J.

Low. Extrem. Wounds 2005, 4(4): 214-24.

Download PDF Evidence Paper

The healing properties of PROMOGRAN in venous leg ulcers

Vin, F., Teot, L., Meaume, S. J.

Wound Care, 2002, 11(9), 335-41

Download PDF Evidence Paper

A randomized controlled trial of PROMOGRAN (a collagen/oxidised regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers

Veves, A., Sheehan, P., Pham, H.T.

Arch Surg, 2002, 137(7), 822-7.

Download PDF Evidence Paper

Use of a protease modulating matrix in the treatment of pressure sores

Nisi, G., Brandi, C., Grimaldi, L., Calabrò, M., D’Aniello, C.

Chir Ital, 2005, 57(4), 465-8.

Download PDF Evidence Paper

Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers.

Lázaro-Martinez, J.L., Garcia-Morales, E., Beneit-Montesinos, J.V., Martinez-de-hesus, F.R. Javier Aragon-Sanchez, F.J.

Circ. Esp.2007, 82(1), 27-31.

Download PDF Evidence Paper