Evaluating the number of cellular and/or tissue-based product applications required to treat diabetic foot ulcers and venous leg ulcers in non-hospital outpatient department settings.

IF 1.4 4区 医学 Q3 DERMATOLOGY
Shaun Carpenter, Angelina Ferguson, Devinna Bahadur, Amanda Estapa, Jamie Bahm
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引用次数: 0

Abstract

Background: There is substantial literature supporting the use of cellular and/or tissue-based product (CTP) in managing Wagner grade 1 and 2 diabetic foot ulcers (DFUs) and, to a lesser extent, venous leg ulcers (VLUs). Several studies advocate CTP therapy as an effective method for promoting healing in chronic DFUs and VLUs.

Objective: To evaluate how the number of CTP applications affect healing and wound area reduction (WAR) rates of DFUs and VLUs.

Methods: A multicenter private wound care practice, electronic health record, and database were used to analyze Medicare patients receiving CTPs between January 1, 2018, and December 31, 2023. Wound treatments occurred in the nursing home, private office, and home settings, not in hospital outpatient department settings. This privately funded, non-vendor-sponsored, real-world retrospective analysis included wound closure and WAR rates after each CTP application. Analysis includes current (2024) aspects of proposed local coverage determination changes that limit the number of CTP applications to 4. A paired t test was used to compare mean wound area before CTP applications and after completing CTP applications over a 16-week period. Effect sizes were analyzed using Cohen d, and correlations between the number of CTP applications and WAR were determined using the Pearson correlation coefficient.

Results: A total of 257 wounds were reviewed for analysis, of which 123 were DFUs and 134 were VLUs. For both DFUs and VLUs, there was a significant difference in the average initial wound areas (cm2) compared with the average wound areas after the CTP application series (P < .001).

Conclusion: This comprehensive retrospective real-world analysis of Medicare patients receiving CTP therapy in conjunction with standard of care treatment of DFUs and VLUs demonstrated significant reduction in the average wound area after completing a CTP application series. The results of this study could be used as a guide for the average number of CTP applications required for the effective treatment of DFUs and VLUs.

评估在非医院门诊部环境中治疗糖尿病足溃疡和静脉腿部溃疡所需的细胞和/或组织类产品应用数量。
背景:有大量文献支持使用细胞和/或组织基产品 (CTP) 治疗瓦格纳 1 级和 2 级糖尿病足溃疡 (DFU),其次是静脉腿部溃疡 (VLU)。有几项研究认为,CTP疗法是促进慢性DFU和VLU愈合的有效方法:评估 CTP 应用次数如何影响 DFU 和 VLU 的愈合率和伤口面积缩小率:采用多中心私人伤口护理实践、电子健康记录和数据库,对 2018 年 1 月 1 日至 2023 年 12 月 31 日期间接受 CTP 的医疗保险患者进行分析。伤口治疗发生在疗养院、私人诊所和家庭环境中,而非医院门诊部环境中。这项由私人资助、非供应商赞助的真实世界回顾性分析包括每次使用 CTP 后的伤口闭合率和 WAR 率。分析包括当前(2024 年)拟议的地方承保范围确定变更方面,该变更将 CTP 应用次数限制为 4 次。采用配对 t 检验来比较 16 周内 CTP 应用前和完成 CTP 应用后的平均伤口面积。使用 Cohen d 分析效应大小,使用皮尔逊相关系数确定 CTP 应用次数与 WAR 之间的相关性:共对 257 例伤口进行了分析,其中 123 例为 DFU,134 例为 VLU。对于 DFU 和 VLU,最初的平均伤口面积(平方厘米)与使用 CTP 系列后的平均伤口面积相比有显著差异(P < .001):这项对接受 CTP 治疗和 DFU 和 VLU 标准治疗的医保患者进行的全面回顾性真实世界分析表明,在完成一系列 CTP 应用后,平均伤口面积明显缩小。这项研究结果可作为有效治疗 DFU 和 VLU 所需的 CTP 平均应用次数的指南。
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来源期刊
CiteScore
1.50
自引率
11.80%
发文量
77
审稿时长
6-12 weeks
期刊介绍: Wounds is the most widely read, peer-reviewed journal focusing on wound care and wound research. The information disseminated to our readers includes valuable research and commentaries on tissue repair and regeneration, biology and biochemistry of wound healing, and clinical management of various wound etiologies. Our multidisciplinary readership consists of dermatologists, general surgeons, plastic surgeons, vascular surgeons, internal medicine/family practitioners, podiatrists, gerontologists, researchers in industry or academia (PhDs), orthopedic surgeons, infectious disease physicians, nurse practitioners, and physician assistants. These practitioners must be well equipped to deal with a myriad of chronic wound conditions affecting their patients including vascular disease, diabetes, obesity, dermatological disorders, and more. Whether dealing with a traumatic wound, a surgical or non-skin wound, a burn injury, or a diabetic foot ulcer, wound care professionals turn to Wounds for the latest in research and practice in this ever-growing field of medicine.
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