A Phase 4 interventional study of Myriad™ applied in conjunction with NPWT and NPWT Alone in Soft Tissue Defects, Soft Tissue Wounds and Traumatic Soft Tissue Defect, sponsored by Aroa Biosurgery Limited. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Aroa Biosurgery Limited · Phase 4, Interventional, and Treatment
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 into the patient's soft tissue during the wound healing process.
Myriad devices are composed entirely of OFM and are available in either a sheet ("Matrix") or particulate ("Morcells") configuration. The devices are applied directly to soft tissue defects to support tissue infill and coverage. These devices have been the subject of multiple clinical studies across a spectrum of applications in wound healing, soft tissue repair, and plastic and reconstructive surgery. These studies, together with extensive preclinical testing, provide background information regarding the use of Myriad devices across a range of procedures in the general patient population.
The present study has been designed as a randomized clinical investigation to evaluate outcomes associated with the use of Myriad devices in the treatment of traumatic wounds when used in combination with negative pressure wound therapy (NPWT). Myriad devices are indicated for soft tissue repair and reconstruction and may be used at the discretion of the attending physician. Myriad devices may be used concomitantly with NPWT across a wide range of surgical procedures where soft tissue is missing or damaged.
This randomized clinical investigation design has been selected to generate additional clinical evidence to evaluate time (in days) to achieve complete tissue coverage of exposed structures, wound volume reduction, wound area reduction, and other key clinical parameters in traumatic wound management.
Aroa Biosurgery Limited is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be considered eligible for the study based on the following criteria:
Exclusion Criteria:
Patients will be excluded from the study based on the following criteria:
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
Device: Myriad™ applied in conjunction with NPWT
NPWT alone ('NPWT')
Device: NPWT Alone
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
Control Arm: NPWT alone ('NPWT')
Tissue Coverage
Time (days) to complete tissue coverage of the exposed structure
Time frame: Up to 56 days/ 8 week follow up
Complete coverage of exposed structures
Percent of defects with complete coverage of exposed structures by 4 weeks
Time frame: up to 28 days (4 weeks)
Post operative complications
Percent of patients with post operative complications (defined as seroma, hematoma, minor infection (cellulitis), major infection (requiring additional surgical intervention, incision and drainage, debridement, additional usage of/change in antibiotic therapy), or skin necrosis/dehiscence)
Time frame: Up to 56 days/ 8 week follow up
NPWT Usage
Length of Negative Pressure Wound Therapy (NPWT) usage (days)
Time frame: Up to 56 days/ 8 week follow up
Wound depth infill
Rate of depth infill (mm per week)
Time frame: 56 days/up to 8 weeks
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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Aroa Biosurgery Limited