CNTR has partnered with Aroa Biosurgery Limited to launch the COVER (Combined OFM and Vacuum-assisted therapy for Expedited Regeneration over Structures) study, to explore accelerated soft tissue coverage of exposed bone and tendon injuries in trauma and acute care surgery (ACS).

This is a randomized, controlled, double-arm clinical investigation of Ovine Forestomach Matrix (OFM) devices as an adjunct to negative pressure wound therapy (NPWT) to accelerate soft tissue coverage in the upper and lower extremities (NCT07385313). Once stabilized, patients will be randomized to receive either NPWT alone, or application of OFM (Myriad Matrix™ and Myriad Morcells™) in conjunction with NPWT.

The primary endpoint will be patients that achieve stable soft tissue coverage of the exposed structure within four weeks. Led by study chair LTC Julie Rizzo, MD, the study has received institutional review board approval and will begin enrollment this month at UT Health San Antonio and the University of Colorado Anschutz.

This randomized controlled trial is expected to expand upon a recently published study entitled “Vascularized Tissue Coverage of Trauma and Acute Care Surgery Defects with Ovine Forestomach Matrix: Interim Results of a Prospective Multicenter Study” in the Journal of Trauma and Injury.

In this study, OFM was employed as a graft (Myriad Matrix™) and/or in particulate form (Myriad Morcells™) to manage deep traumatic and acute defects across four Level I trauma centers. Of note, this report is focused on an interim subgroup analysis of the largest ongoing prospective, multicenter study of a dermal substitute in soft tissue reconstruction (MASTRR Trial), investigating the safety and efficacy of OFM devices in surgical applications.

The article mentioned herein demonstrated that, in most cases, a single application of OFM achieved vascularized tissue coverage in a median of ~23 days, despite most wounds being large, contaminated, and often with exposed structures. Most commonly, patients achieved full wound closure around 70 days, either through secondary intention healing or split-thickness skin graft placement, with minimal complications, as well as excellent patient-reported pain and scar satisfaction scores.

This study also included a literature synthesis highlighting that OFM had similar or better clinical outcomes compared to other dermal substitutes used in trauma and acute care surgery.

Dr. Michael Cormican, a trauma surgeon at Northeast Georgia Medical Center and one of the authors, said, “This prospective data provides validation to what we were already seeing in surgical practice, that Myriad offers a cost-effective solution to improve coverage and healing of complex trauma defects without adding risk to the patient.”

The CNTR study aims to add evidence to validate a treatment algorithm for achieving rapid coverage of soft tissue defects presenting to trauma/ACS teams in a cost-effective manner, increasing patient satisfaction and hospital efficiency.