Bilayer
Healing Technology for Large-Bed Wounds and Burns
for faster closing and invisible scars
ClotFoam Bilayer is a dressing designed for large wound healing applications and scar elimination. Rapid and proper healing is a challenge in the treatment of wounds such as severe burns, trauma, diabetic, and similar tissue damages. These Type of wounds represent a major burden upon world healthcare costs.
ClotFoam Bilayer is a wound dressing idesigned as a skin substitute for full thickness burns-wounds, or scaffold dressing onto which cells can attach and replicate the damaged structure. It achieves the functions of the natural skin providing support and functionality for the proliferating cells, beyond physical protection and an optimal moisture environment for the wound.
ClotFoam Bilayer accelerates healing and normalizes tissue architecture through the controlled release of anti-inflammatory agents, growth factors and extracellular matrix components. ound dressings that possess functionality
Artificial extracellular matrices functionalized with growth factors (GF) to regenerate tissue offer a significant clinical improvement of large wounds when released in a controlled proteolytic environment. Unlike many products in development that rarely lead to a clinical outcome due to premature inactivation in the wound environment from bacterial infection and proteolytic activity, ClotFoam-B addresses the effects of bacterial infection and proteolytic degradation using a novel composite, which provides epidermal function and an inner fibrin hydrogel scaffold layer.
The technology consolidates important research developments from various studies into a bilayer technology that has shown ideal scaffold properties and remarkable attachment and regeneration functions. Biocompatibility, biodegradation, shelf life, resistance to photolytic activity, and non-immunogenic characteristics have the potential to overcome the obstacles observed in the development of functional wound dressings.
The ClotFoam-B, scaffold provides an optimal dermal precursor to modulate matrix deposition, attenuating myeloperoxidase (MMP) activity and preventing infection. Growth factors are delivered by sequential releasing methods in a proteolytic inhibited medium.
The novel composite consists of: 1) a regenerative fibrin hydrogel scaffold layer, the so-called smart matrices, with remarkable adhesion and regenerative properties; and b) a nonkeratinized stratified squamous epithelium with nonviable cells, which provides epidermal function. The scaffold is biodegradable, biocompatible, non-immunogenic, and suitable for easy modification of the functionality of the molecules, covalent attachment of growth factors (GF), and/or incorporation of GF, protease inhibitors and antimicrobial loaded microspheres.
The sequential release system of growth factors and antibacterial agents consists of 1) gelatin microspheres; 2) microspheres of polyelectrolyte complexes; and 3) covalent attachment by calcium-independent tranglutaminase enzyme (ACTIVA).The multiple delivery systemis loaded with basic fibroblast growth factor (FGF-2), VGEF, EGF, platelet-derived growth factor (PDGF), Transforming growth factor (TGF)-β1, antimicrobials and enzyme inhibitors.
Effect of ClotFoam on Wound Healing.
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Figure 1 shows fibrin at the surface overlying granulation tissue. No exudate is noted. In contrast, sections obtained from control animals without ClotFoam-B treatment (Fig. 2) shows extensive acute inflammatory exudates on the surface |
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1Healing Skin Wound Over Time.
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Animals which did not receive ClotFoam-B demonstrated dermal scarring with abundant areas of collagen and a maximum thickness of approximately 1.9mm at 14 days (Fig.3). In contrast, sections obtained from ClotFoam-B treated animals showed dermal scarring with evenly dispersed collagen and a maximum thickness of approximately 1.1mm (Fig. 4) |
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Animals which did not receive ClotFoam-B demonstrated numerous fusiform cells within the dermal scar (Fig 5) but only occasional cells show positive staining with anti-smooth muscle actin antibodies, which indicates myofibroblastic differentiation (fig 6). |
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