Bettle Griscom, Bell Desmond P, Bakewell Suzanne J
Department of Clinical Research and Development, Omeza, LLC, 1610 Northgate Boulevard, Sarasota, FL, 34234, USA.
Adv Ther. 2024 Feb;41(2):492-508. doi: 10.1007/s12325-023-02742-4. Epub 2023 Dec 16.
Following the clinical perspective and concept that a healthy body will not develop chronic wounds, the central approach for the treatment described here is based on an understanding of how the body transforms the wound microenvironment from a non-healing to a healing state. As part of a comprehensive treatment regimen that includes OCM™ (complete matrix), wound preparation, and skin protectant formulations, the OCM contains components for complete wound healing by attending to the individual needs required to promote the closure of each unique chronic wound. During application of the comprehensive treatment regimen in independent investigator-led trials, the total wound percentage average reduction over the first 4 weeks of treatment was 60% across multiple wound types; median time to total wound closure was 6.9 weeks. Safety testing of the OCM formulation shows no potential allergenicity, no potential sensitization, and no known product-related adverse events. Clinical trials evaluating the OCM formulation as part of the comprehensive treatment regimen of multiple wound types are underway. Results of clinical trials and real-world experiences will expand current knowledge of the wound-healing potential of this novel product.
基于健康的身体不会产生慢性伤口这一临床观点和理念,此处所述治疗方法的核心是基于对身体如何将伤口微环境从非愈合状态转变为愈合状态的理解。作为包括OCM™(完整基质)、伤口预处理和皮肤保护剂配方在内的综合治疗方案的一部分,OCM通过满足促进每个独特慢性伤口愈合所需的个体需求,包含促进伤口完全愈合的成分。在独立研究者主导的试验中应用该综合治疗方案时,多种伤口类型在治疗的前4周内伤口总面积平均减少了60%;伤口完全愈合的中位时间为6.9周。OCM配方的安全性测试表明,其无潜在致敏性、无潜在致敏现象,且无已知的与产品相关的不良事件。目前正在进行评估OCM配方作为多种伤口类型综合治疗方案一部分的临床试验。临床试验结果和实际应用经验将拓展对这种新产品伤口愈合潜力的现有认知。