Real-World Use and Outcomes of Hard-To-Heal Wounds Managed With Porcine Placental Extracellular Matrix.

Abstract

Real-world data are a highly valuable resource in determining the efficacy of novel products in challenging populations, especially in wound care. This study retrospectively analyzed the real-world performance of porcine placental extracellular matrix (PPECM; InnovaMatrix® AC, Convatec Triad Life Sciences, LLC, Memphis, TN, USA), a novel cellular, acellular, and matrix-like product for the management of hard-to-heal wounds. The US Wound Registry (USWR), which comprises aggregated and structured electronic health records from 502 wound practices, provided a deidentified dataset collected from October 10, 2022 to March 25, 2024, containing 76,278 patients (248,278 wounds). Screening for PPECM usage identified 60 wounds in 41 patients. The median age was 74 (IQR: 66-80) years; 20 (49%) had impaired ambulation, five (12%) autoimmune diseases, and five (12%) peripheral arterial diseases. The most common wounds included 18 (30%) chronic ulcers, 12 (20%) diabetic ulcers, seven (12%) pressure ulcers or injuries, seven (12%) dehisced surgical wounds, and six (10%) venous leg ulcers. Median surface area was 1.50 (IQR: 0.42-4.69) cm²; 31 (52%) of the wounds were limb/life-threatening (L/LT); nine (17%) were present >1 year; 52 (87%) had bioburden/infection. Only two (3%) of the wounds had no necrotic tissue at the initial application. Following PPECM management, 32 (53%) of the wounds closed (of which 14 (44%) were L/LT) and five (8%) had major improvement (three (60%) L/LT). No adverse events were reported. This is the first clinical study of PPECM and demonstrates the real-world safety and efficacy of PPECM in the management of hard-to-heal wounds in a complex population.