Preclinical Evaluation of Soft and Rigid Porous Matrices for Wound Healing in a Diabetic Mouse Model Editorial Summary This preclinical study evaluates soft and rigid porous matrices for wound healing in a diabetic mouse model, addressing the critical need for effective treatments for large surface area wounds. While allogeneic and xenogeneic matrices have shown promise, they face limitations in cost, durability, and variability. Recent years have seen a push towards novel biodegradable or absorbable synthetic matrices to overcome these challenges. The study compares the wound healing properties of a soft, porous, single-layered, bioabsorbable polyurethane matrix (MTX) with a rigid Bilayer matrix in a diabetic mouse model. The research aims to elucidate the mechanisms of action and differentiate these products from other offerings in the field. Key aspects of the study include gene expression analysis, proteomics, biomechanical properties, and histology to understand how these synthetic products heal chronic wounds. The investigation employs a delayed healing model in diabetic mice to simulate real-world clinical conditions. This research has significant implications for clinical practice, potentially guiding the development and application of advanced wound healing products for patients with challenging wounds, such as those associated with diabetes.
Introduction
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Dr. Mitchell Corey Sanders CEO, ProDevLabs, LLC Southborough, MA
Nikole Siegmund VP of Preclinical Development, ProDevLabs, LLC
Mia Hanna Scientist, ProDevLabs, LLC Southborough, MA
Southborough, MA
Dr. Akram M. Salam Scientist, ProDevLabs, LLC Southborough, MA
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Dr. Joshua Cheetham Director of Research and Development, PolyNovo Limited Melbourne, Australia
Wound Masterclass - Vol 3 - December 2024
ealing large surface area wounds is a very challenging unmet need in clinical practice. Although there has been a surge in the development of allogenec and xenogenic matrices for healing wounds, these products have significant limitations including, but not limited to, cost, durability, longevity, and donor and process variability. In the last five years there has been a push in the marketplace to provide novel biodegradable or absorbable synthetic matrices that reduce these limitations of the naturally derived products. Some examples of the current biodegradable and resorbable matrices on the market include NovoSorb® BTM, Suprathel®, Supra SDRM®, Altrazeal®, AC5, Integra® Bilayer (Bilayer), G4Derm, Restrata®, Phoenix Wound Matrix®, Spincare™ Microlyte®, Mirrage® and NovoSorb® MTX (MTX). The clinical indications for use of these products have been provided in recent reviews.1-3 Each of these porous matrices have their inherent benefits and limitations, but few studies have compared the products in clinical or even preclinical studies to provide a direct comparison of the potential benefits and weaknesses. Some of the features of an ideal biosynthetic dressing are provided in Table 1. One obvious feature is that the products need to enhance wound healing at a reasonable cost. Limited clinical studies suggest that this novel class of wound matrices may also improve wound oxygenation, cell attachment and proliferation, fresh granulation tissue formation, and accelerate angiogenesis. Some of these products also have the added benefit of potentially reducing pain, wound contraction, water loss, and scarring, as well as lowering pH, which is known to control bacterial bioburden in a wound. One new product that recently received 510(K) clearance is a soft, porous, single-layered, bioabsorbable polyurethane matrix referred to as MTX. Although case studies with this resorbable matrix seem to suggest a lot of promise for its use in the clinical setting, the mechanism of action of how this product accelerates wound healing and how this product differentiates itself from other product offerings in this class is poorly understood. The primary goal of this was study was to compare the wound healing properties of the soft and porous MTX matrix with that of a rigid Bilayer matrix which is a competing product in the same class of bioabsorbable matrices. Our hypothesis was that a delayed healing model in the diabetic mouse may elucidate some of the indications for use of these products to help guide clinical practice. Our secondary goal was to analyze wound gene expression, proteomics, biomechanical properties, and histology to better understand the mechanism of action of how these synthetic products heal chronic wounds.