Copeland Karen, Purvis Angie R
Boulder Statistics, LLC, Boulder, Colorado.
Angie Purvis, LLC, Evergreen, Colorado.
Adv Wound Care (New Rochelle). 2017 May 1;6(5):143-152. doi: 10.1089/wound.2017.0729.
Topical oxygen devices are Food and Drug Administration (FDA) cleared for the following indications for use of various etiologies: skin ulcerations due to diabetes, venous stasis, postsurgical infections and gangrenous lesions, decubitus ulcers; amputations/infected stumps; skin grafts; burns; and frostbite. The goal of this study was to understand the impact of topical oxygen therapy (TOT) on patient outcomes, including amputation and healing rates. This retrospective chart review included records collected between January 1, 2007, and July 18, 2016, from male and female patients ranging in age from 4 years to 105 years. All wounds were at least 1 cm and were treated with at least one separate modality before treatment with TOT and then treated with TOT for a minimum of 2 weeks in compliance with the FDA-approved indications. All records were from wounds that were no longer being treated with TOT. In this study, TOT was associated with an overall rate of 59.4% for a reduction in chronic wound size, while 41.6% of wounds had no healing. The overall amputation rate was 2.4% for wounds in this study. To our knowledge, this retrospective chart review represents one of the largest data sets (4,127 total wounds) collected over one of the longest time periods (9.5 years) to evaluate patient outcomes following TOT. This study revealed healing and amputation rates similar to those reported in controlled clinical studies using TOT to treat chronic wounds.
局部给氧设备已获得美国食品药品监督管理局(FDA)批准,可用于以下各种病因的适应症:糖尿病引起的皮肤溃疡、静脉淤滞、术后感染和坏疽性病变、褥疮;截肢/感染残端;皮肤移植;烧伤;以及冻伤。本研究的目的是了解局部氧疗(TOT)对患者预后的影响,包括截肢率和愈合率。这项回顾性病历审查纳入了2007年1月1日至2016年7月18日期间收集的记录,涉及年龄在4岁至105岁之间的男性和女性患者。所有伤口至少1厘米,在接受TOT治疗前至少采用一种单独的治疗方式,然后按照FDA批准的适应症接受TOT治疗至少2周。所有记录均来自不再接受TOT治疗的伤口。在本研究中,TOT与慢性伤口大小总体减少率59.4%相关,而41.6%的伤口未愈合。本研究中伤口的总体截肢率为2.4%。据我们所知,这项回顾性病历审查是在最长时间段(9.5年)之一收集的最大数据集(共4127个伤口)之一,用于评估TOT后的患者预后。这项研究揭示的愈合率和截肢率与使用TOT治疗慢性伤口的对照临床研究报告的结果相似。