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Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study
Lymphatic Research and Biology ( IF 1.4 ) Pub Date : 2022-04-20 , DOI: 10.1089/lrb.2020.0126
Stanley G Rockson 1 , Pinar Karaca-Mandic 2 , Roman Skoracki 3 , Karen Hock 3 , Michelle Nguyen 4 , Kristin Shadduck 4 , Phyllis Gingerich 5 , Elizabeth Campione 6 , Andrea Leifer 7 , Jane Armer 8
Affiliation  

A diagnosis of lymphedema comes with a lifetime requirement for careful self-care and treatment to control skin deterioration and the consequences of excessive fluid and protein buildup leading to abnormal limb volume and an increased risk of infection. The burden of care and psychosocial aspects of physical disfiguration and loss of function are associated with compromised quality of life (QoL). The current standard therapeutic intervention is complex decongestive therapy with manual lymph drainage and frequent wearing of compression garments. With insurance limitations on therapy visits and the time and travel required, additional home treatment options are needed. Pneumatic compression pumps that mimic the manual massage pressure and pattern are sometimes prescribed, but these are bulky, difficult to apply, and require immobility during treatment. An open-label pilot study in 40 subjects was performed to evaluate the QoL and limb volume maintenance efficacy of a novel wearable compression system (Dayspring™) that is low profile, easy to use, and allows for mobility during treatment. After 28 days of use, subjects had a statistically significant 18% (p < 0.001) improvement in overall QoL as measured by the Lymphedema Quality-of-Life Questionnaire compared with baseline. Individual QoL domains, and limb volume improved with therapy. Adherence was 98% over the course of the study. Results of the clinical evaluation suggest the Dayspring wearable compression device is safe and effective and improves QoL and limb volume. The novel, low-profile device is easy to use and allows for mobility during treatment, addressing a potential barrier to adherence with pneumatic compression devices.

中文翻译:

一种新型可穿戴加压技术治疗淋巴水肿的临床评价,一项开放标签对照研究

淋巴水肿的诊断伴随着终生需要仔细的自我护理和治疗以控制皮肤恶化以及过多的液体和蛋白质积聚导致肢体体积异常和感染风险增加的后果。身体毁容和功能丧失的护理负担和心理社会方面与生活质量 (QoL) 受损有关。目前的标准治疗干预是复杂的减充血疗法,包括手动淋巴引流和频繁穿着压缩衣。由于治疗访问的保险限制以及所需的时间和旅行,需要额外的家庭治疗选择。有时会开出模拟手动按摩压力和模式的气动压缩泵,但它们体积庞大,难以应用,并且在治疗期间需要不动。对 40 名受试者进行了一项开放标签试点研究,以评估新型可穿戴压缩系统 (Dayspring™) 的 QoL 和肢体体积维持效果,该系统低调、易于使用并允许在治疗期间移动。使用 28 天后,受试者的 18%(p  < 0.001) 与基线相比,通过淋巴水肿生活质量问卷测量的整体 QoL 有所改善。个体生活质量域和肢体体积通过治疗得到改善。在整个研究过程中,依从性为 98%。临床评估结果表明,Dayspring 可穿戴加压装置安全有效,可改善生活质量和肢体体积。这种新颖、低调的装置易于使用,并允许在治疗期间移动,解决了与气动压缩装置粘附的潜在障碍。
更新日期:2022-04-20
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