Aroa Biosurgery, in collaboration with the Coalition for National Trauma Research (CNTR), has initiated a groundbreaking pilot study evaluating the efficacy of combining the company’s Ovine Forestomach Matrix (OFM) grafts (Myriad Matrix^TM) with conventional Negative Pressure Wound Therapy (NPWT) in patients suffering from traumatic soft tissue injuries. The study aims to determine whether this combined treatment approach can accelerate the formation of vascularized tissue over exposed bone, tendon, or neurovascular structures compared to NPWT alone.

Julie Rizzo, MD, Trauma Research Director at Brooke Army Medical Center, and the study PI, said, “The importance of early and complete coverage of vital structures, such as tendon and bone, is paramount to a trauma patient’s recovery. The utilization of innovative wound care products, such as Myriad Matrix, offers the opportunity for rapid coverage of wounds and is easy to care for by both providers and patients.”

CNTR is now recruiting sites for this randomized, interventional clinical trial, titled Randomized Prospective Evaluation of Ovine Forestomach Matrix (OFM) and NPWT to Accelerate Tissue Infill and Coverage Over Exposed Bone & Tendon. The study will enroll 30 adult patients across up to three U.S. trauma centers. Each patient will have a full-thickness soft tissue defect requiring reconstruction. The study’s primary endpoint is the time to coverage of exposed structures, with secondary endpoints including volume and area reduction of the defect, NPWT usage duration, and surgical site complications.

“As a company, we’re committed to rigorous scientific exploration of our technologies to definitively show what they’re capable of,” said Adam Young, PhD, Aroa Vice President of Medical Affairs. “The achievement of vascularized tissue infill and coverage better equips trauma patients for success in their healing journey.”

In addition to site recruitment, CNTR is responsible for IRB submissions and approvals, clinical monitoring and regulatory compliance, site reimbursements, and data collection and analysis.

The pilot study is anticipated to be completed within 12 months. If successful, the findings could pave the way for expanded studies and inform surgical practices for patients with complex defects requiring advanced soft tissue reconstruction.

Committed to “Unlocking regenerative healing for everybody,” Aroa Biosurgery was founded in 2008 and is headquartered in Auckland, New Zealand.

To be considered, interested sites may complete THIS SURVEY.