Real-world Use of Porcine Placental Extracellular Matrix in Hard-to-Heal Wounds

Introduction: The treatment of hard-to-heal wounds remains a significant clinical challenge. Real-world evidence is essential to understand the effectiveness of products among typical patients and wounds. We evaluated the real-world performance of porcine placental extracellular matrix (PPECM), a novel cellular and/or tissue-based product engineered to facilitate tissue regeneration and wound healing by acting as a scaffold.Methods:The US Wound Registry (USWR) is comprised of the aggregated electronic health records (EHRs) of 502 wound centers using a highly structured EHR to provide research-ready, real-world data. Following IRB approved waiver of consent, a HIPAA deidentified dataset from 10/10/22 to 3/25/24 containing 76,073 patients with 248,278 wounds was screened for PPECM use. Healing outcomes were assessed by single observer chart review and confirmed by remote adjudication. Descriptive statistics analyzed data; medians and interquartile ranges (IQRs) were used for nonnormal data distribution.Results:Sixty wounds in 41 patients were treated with PPECM. Median (IQR) patient age was 74 years (14) with a median of 2 wounds per patient: 44% had impaired ambulation or were bedridden; 39% were obese; 12% had autoimmune disease; 12% had peripheral arterial disease; and 12% had hypertension. Wound types included: chronic ulcers (30%), diabetic ulcers (20%), pressure injuries (12%), dehisced surgical wounds (12%), venous leg ulcers (10%), traumatic wounds (8%), and arterial ulcers (3%). Median surface area was 5.0 cm2 (12.3 cm2); 12% of wounds had exposed muscle, tendon, or bone; 17% had been present >1 year; and 73% showed signs of infection. Only 3% of wounds had no necrotic tissue at application; 48% had ≥25% necrotic tissue. More than half of wounds (53%) healed following PPECM treatment, of which 44% were limb- or life-threatening (L/LT); 8% improved (60% L/LT); 22% did not improve (61.5% L/LT); in 17% the outcome was unknown. No adverse events or complications were reported.Discussion: In the real world, wounds of many etiologies were safely treated with PPECM. PPECM successfully closed or improved limb- or life-threatening hard-to-heal wounds among frail patients with significant comorbidities. The results of the study suggest PPECM may offer clinicians a safe, innovative option for the management of hard-to-heal wounds.    References:Carter MJ, Fife CE, Walker D, Thomson B. Estimating the Applicability of Wound-Care Randomized Controlled Trials to General Wound Care Populations by Estimating the Percentage of Individuals Excluded from a Typical Wound Care Population in Such Trials. Adv Skin Wound Care. 22: 316-24, 2009. Fife CE, Eckert KA. Harnessing Electronic Healthcare Data for Wound Care Research: Standards for Reporting Observational Registry Data Obtained Directly from Electronic Health Records. Wound Repair Regen. 25(2): 192-209, 2017.