Fife Caroline, LeBoutillier Ben, Taylor Cristin, Marcinek Brad T
Medicine, Intellicure, LLC, The Woodlands, USA.
Data Management, Intellicure, LLC, The Woodlands, USA.
Cureus. 2024 Dec 23;16(12):e76262. doi: 10.7759/cureus.76262. eCollection 2024 Dec.
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.
真实世界数据是确定新产品在具有挑战性人群中疗效的极有价值的资源，尤其是在伤口护理领域。本研究回顾性分析了猪胎盘细胞外基质（PPECM；InnovaMatrix® AC，康维德三元生命科学公司，美国田纳西州孟菲斯）的真实世界表现，这是一种用于治疗难愈合伤口的新型细胞、无细胞和类似基质的产品。美国伤口登记处（USWR）包含来自502个伤口治疗机构的汇总和结构化电子健康记录，提供了一个去识别化数据集，收集时间为2022年10月10日至2024年3月25日，包含76278名患者（248278处伤口）。筛选PPECM使用情况后，确定了41名患者中的60处伤口。中位年龄为74岁（四分位间距：66 - 80岁）；20名（49%）患者行动不便，5名（12%）患有自身免疫性疾病，5名（12%）患有外周动脉疾病。最常见的伤口包括18处（30%）慢性溃疡、12处（20%）糖尿病溃疡、7处（12%）压疮或损伤、7处（12%）手术切口裂开和6处（10%）下肢静脉溃疡。中位表面积为1.50平方厘米（四分位间距：0.42 - 4.69平方厘米）；31处（52%）伤口对肢体/生命构成威胁（L/LT）；9处（17%）伤口存在时间超过1年；52处（87%）伤口有生物负荷/感染。初次应用时，只有2处（3%）伤口没有坏死组织。经过PPECM治疗后，32处（53%）伤口愈合（其中14处（44%）为L/LT伤口），5处（8%）有显著改善（3处（60%）为L/LT伤口）。未报告不良事件。这是关于PPECM的首次临床研究，证明了PPECM在复杂人群中治疗难愈合伤口的真实世界安全性和有效性。
