McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
University of Pittsburgh Medical Center Health System Wound Care Service, Pittsburgh, Pennsylvania, USA.
Adv Wound Care (New Rochelle). 2023 Dec;12(12):657-670. doi: 10.1089/wound.2023.0150.
Chronic wounds affect 10.5 million (up 2.3 million from the 2014 update) of U.S. Medicare beneficiaries. Chronic wounds impact the quality of life of nearly 2.5% of the total population of the United States. This fraction is larger in the elderly. These wounds can lead to a range of complications and health care costs. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. Disparities in the prevalence and management of chronic wounds exist, with underserved communities and marginalized populations often facing greater challenges in accessing quality wound care. These disparities exacerbate the public health burden. U.S. Centers for Medicare and Medicaid Services had proposed revision of its local coverage determination limiting the use of skin substitute grafts/cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers in the U.S. Medicare population. In response to the comment phase, this proposal has been put on hold. The U.S. Food and Drug Administration (FDA) has renewed its focus on addressing nonhealing chronic wounds and has outlined efforts to address identified barriers to product development for nonhealing chronic wounds. The new approach places emphasis on engaging key wound healing stakeholders, including academia, professional associations, patient groups, reimbursement organizations, and industry. Finally, recent advances demonstrating that wounds closed by current FDA definition of wound closure may remain functionally open because of deficiencies in restoration of barrier function warrant revisiting the wound closure endpoint. Such "closed" wounds that are functionally open, also known as invisible wounds, are likely to be associated with high wound recurrence. Addressing the public health problem of chronic wounds will require a multifaceted approach that includes prevention, improved wound care management, and addressing the underlying risk factors.
慢性伤口影响了 1050 万（比 2014 年更新增加了 230 万）美国医疗保险受益人。慢性伤口影响了近 2.5%的美国总人口的生活质量。在老年人中，这一比例更大。这些伤口可能导致一系列并发症和医疗保健费用。鉴于人口老龄化、全球糖尿病和肥胖的持续威胁以及感染的持续问题，预计慢性伤口将继续成为一个重大的临床、社会和经济挑战。慢性伤口的患病率和管理存在差异，服务不足的社区和边缘化人群在获得高质量伤口护理方面往往面临更大的挑战。这些差异加剧了公共卫生负担。美国医疗保险和医疗补助服务中心（Centers for Medicare and Medicaid Services）曾提议修订其地方覆盖范围决定，限制在美国医疗保险人群中使用皮肤替代物移植物/细胞和/或组织基产品治疗糖尿病足溃疡和静脉溃疡。针对评论阶段，该提案已被搁置。美国食品和药物管理局（FDA）已重新将重点放在解决非愈合性慢性伤口上，并概述了努力解决非愈合性慢性伤口产品开发中确定的障碍。新方法强调让包括学术界、专业协会、患者团体、报销组织和行业在内的关键伤口愈合利益相关者参与进来。最后，最近的进展表明，根据当前 FDA 对伤口愈合的定义，通过闭合的伤口可能由于屏障功能恢复的缺陷仍然保持功能上的开放，这需要重新审视伤口愈合终点。这种“闭合”但功能上仍为开放的伤口，也称为隐形伤口，很可能与高伤口复发率有关。解决慢性伤口的公共卫生问题需要采取多方面的方法，包括预防、改善伤口护理管理和解决潜在的风险因素。
