Study of 411 patients assessed the safety of an ovine scaffold for soft tissue repair

Study of 411 patients assessed the safety of an ovine scaffold for soft tissue repair

An article published on September 3 reported interim data from the MASTRR registry: Myriad devices were used in 411 patients with 474 complex soft tissue defects at ten US centers. The authors tracked adverse events and assessed their relationship to the device.

Trauma, surgery, or burns can leave a large defect in the skin, fat, or muscle. A surgeon can temporarily cover the defect with a biological scaffold. Myriad is made from ovine forestomach extracellular matrix, the structural material of the tissue, which provides a temporary scaffold for repair. Cells and blood vessels grow into the scaffold, and the body then remodels it along with the healing tissue.

MASTRR is a prospective registry: before data collection began, physicians specified which data they would collect during routine surgical care. At ten US centers, they recorded adverse events using a common scale and assessed their relationship to Myriad.

Nearly 60% of defects had persisted for more than a month; participants often had type 2 diabetes and vascular disease, which can complicate tissue repair. Median follow-up was 27,1 weeks: half the patients were followed for longer and half for less time.

During this period, 59 adverse events were recorded in 50 patients (12,2%). Superficial infection occurred in 2,9% of participants, and deep infection in 0,7%. The only adverse event considered probably related to Myriad was a skin reaction involving redness, pain, and swelling. Treatment involved removing 40% of the scaffold and administering antihistamines, followed by coverage with a split-thickness skin graft. According to the registry entry, recruitment is ongoing; planned enrollment is 800 participants, and the primary outcome is the proportion of participants with adverse events over three years.