Aroa Biosurgery Limited
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Ovine forestomach matrix (OFM) is a decellularized extracellular matrix bioscaffold developed for a range of soft tissue repair, reconstruction, and wound healing applications. OFM is a platform technology used in numerous products, including Myriad™ Matrix, Endoform™ Natural, Endoform™ Antimicrobial, and Ovitex® Reinforced Bioscaffolds. Preclinical and clinical studies have evaluated OFM with respect to mesenchymal stromal cell recruitment, cellular proliferation, angiogenesis, vascularization, and modulation of wound protease activity. Over time, the OFM material is resorbed and incorporated…
Inclusion Criteria: * Patients will be considered eligible for the study based on the following criteria: * Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan * Male or female patients aged 18 years or above * Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity. * Total defect size, range 25 to 800 cm2 Exclusion Criteria: * Patients will be excluded from the study based on the following criteri…
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
Control Arm: NPWT alone ('NPWT')
Arctuva estimate
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