1000_Tarricone.pdf

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1、Complex Wound Closure&the ODINN TrialFrom Asgard to ODINNArthur Tarricone,DPM,MPH The University of Texas at San AntonioObjectives Discuss Skin Substitute landscape Discuss Pivotal trials of skin substitutes Discuss ODINN Data Chronic Wounds Diabetic foot ulcers(DFUs)are a serious complication of di

2、abetes.They are difficult to heal and can lead to severe infections and amputation.Traditional standard of care(SOC)often fails for complex wounds,leaving a significant unmet medical need.There is a lack of high-quality,large-scale clinical evidence for advanced wound care products,particularly for

3、severe ulcers.The Skin Substitute Landscape What is a Skin Substitute?A bioengineered product used to cover wounds and promote healing.Categories:Cellular/Tissue-Based:Contain living cells(e.g.,Apligraf,Dermagraft).Acellular:Do not contain living cells;act as a scaffold(e.g.,Integra,Kerecis).Source:

4、Human(allograft/amniotic),animal(xenograft),or synthetic.CeCellular Based Graftsllular Based GraftsProductCompositionKey DifferencesApligrafBi-layered,Bioengineered.Contains living human keratinocytes(epidermal layer)and living human fibroblasts in a bovine collagen matrix(dermal layer).It is a comp

5、osite of different cell types and a non-human matrix.It is the only product listed that is engineered with two distinct layers mimicking the natural skin structure(epidermis and dermis)using living cells and a bovine-derived scaffold.DermagraftDermal Substitute.Composed of living human fibroblasts g

6、rown on a bioabsorbable polyglactin mesh scaffold.The fibroblasts secrete extracellular matrix,growth factors,and cytokines.It is a dermal substitute as it primarily provides a living fibroblast layer on a synthetic scaffold.It does not contain an epidermal component like Apligraf.GrafixCryopreserve