NCT07385313

Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures

Randomized Prospective Evaluation of Ovine Forestomach Matrix (OFM) and NPWT to Accelerate Tissue Coverage Over Exposed Structures

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aroa Biosurgery Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone

Detailed description

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.

Conditions

• Soft Tissue Defects
• Soft Tissue Wounds
• Traumatic Soft Tissue Defect

Interventions

Type	Name	Description
DEVICE	Myriad™ applied in conjunction with NPWT	Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
DEVICE	NPWT Alone	Control Arm: NPWT alone ('NPWT')

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2026-02-04
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study