Early Experience Using Novel Ovine Forestomach Matrix and Hyaluronic Acid Composite Graft in the Outpatient Treatment of Real-World Chronic Lower Extremity Wounds

IIntroduction: n 2020, the burden of chronic wounds impacted the quality of life of approximately 2.5% of the United States population and continues to climb(1). Chronic wounds include those that are unresponsive to appropriate initial therapy or remain persistent for greater than 3 months in the face of appropriate additional care. The occurrence of these wounds leaves patients frustrated and searching for additional options. The goal of this study was to document use of a novel ”Cellular, Acellular, Matrix-like Product” (CAMP), ovine forestomach matrix-hyaluronic acid (OFM-HA) graft, on complicated wounds and patient. This composite CAMP (OFM-HA)  is designed to facilitate cellular infiltration and migration to drive improved wound closure.Methods:This multi-center, retrospective case series included patients with chronic diabetic foot ulcers (DFU) and/or venous leg ulcers (VLU) treated with OFM-HA in the outpatient setting. Endpoints include time to complete closure, percent area reduction (PAR)responders at 4-weeks, incidence of healing at 12-weeks, and number of product applications. All data was gathered retrospectively via electronic medical records. Patients were not excluded due to complex co-morbidities in an effort to reflect real world patient outcomes.Results:All patients achieved complete closure during the study interval with no device-related adverse events. All patients responded to treatment and achieved complete closure with no more than 5 (five) OFM-HA applications during the treatment period.Discussion: OFM-HA was demonstrated to be safe and effective in challenging lower extremity wounds frequently encountered in outpatient wound healing facilities. The number of applications required in this small case series is in line with the proposed limit of CAMP applications as defined by CMS in April 2024. The promising results of this early experience should be further validated by larger prospective studies.References:Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026. PMID: 33733885; PMCID: PMC8024242.