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高真空悬吊可保护下肢截肢患者残肢皮肤健康:随机临床试验。

Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.

作者信息

Rink Cameron, Wernke Matthew M, Powell Heather M, Gynawali Surya, Schroeder Ryan M, Kim Jayne Y, Denune Jeffrey A, Gordillo Gayle M, Colvin James M, Sen Chandan K

机构信息

Department of Surgery, Comprehensive Wound Center, and Dorothy M. Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH.

Ohio Willow Wood Company, Mt. Sterling, OH.

出版信息

J Rehabil Res Dev. 2016;53(6):1121-1132. doi: 10.1682/JRRD.2015.07.0145.

DOI:10.1682/JRRD.2015.07.0145
PMID:28355039
Abstract

UNLABELLED

A growing number of clinical trials and case reports support qualitative claims that use of an elevated vacuum suspension (EVS) prosthesis improves residual-limb health on the basis of self-reported questionnaires, clinical outcomes scales, and wound closure studies. Here, we report first efforts to quantitatively assess residual-limb circulation in response to EVS. Residual-limb skin health and perfusion of people with lower-limb amputation (N = 10) were assessed during a randomized crossover study comparing EVS with nonelevated vacuum suspension (control) over a 32 wk period using noninvasive probes (transepidermal water loss, laser speckle imaging, transcutaneous oxygen measurement) and functional hyperspectral imaging approaches. Regardless of the suspension system, prosthesis donning decreased perfusion in the residual limb under resting conditions. After 16 wk of use, EVS improved residual-limb oxygenation during treadmill walking. Likewise, prosthesis-induced reactive hyperemia was attenuated with EVS following 16 wk of use. Skin barrier function was preserved with EVS but disrupted after control socket use. Taken together, outcomes suggest chronic EVS use improves perfusion and preserves skin barrier function in people with lower-limb amputation.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.

摘要

未标注

越来越多的临床试验和病例报告支持一些定性说法,即使用高真空悬吊(EVS)假体可根据自我报告问卷、临床结果量表和伤口闭合研究改善残肢健康状况。在此,我们报告首次为定量评估EVS对残肢循环的影响所做的努力。在一项随机交叉研究中,使用非侵入性探头(经表皮水分流失、激光散斑成像、经皮氧测量)和功能性高光谱成像方法,比较了EVS与非高真空悬吊(对照)在32周期间对下肢截肢患者(N = 10)的残肢皮肤健康和灌注情况。无论采用何种悬吊系统,在静息状态下佩戴假体都会降低残肢的灌注。使用16周后,EVS改善了跑步机行走期间残肢的氧合情况。同样,使用16周后,EVS减轻了假体诱导的反应性充血。EVS可保持皮肤屏障功能,但使用对照接受腔后皮肤屏障功能会受到破坏。综合来看,结果表明长期使用EVS可改善下肢截肢患者的灌注并保持皮肤屏障功能。

临床试验注册

ClinicalTrials.gov;“与假体真空接受腔系统相关的肢体健康评估”:NCT01839123;https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1 。

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