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Simplified Negative Pressure Wound Therapy Device for Application in Low-Resource Settings

机译:用于低资源环境的简化负压伤口治疗仪

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摘要

Negative pressure wound therapy (NPWT) provides proven wound healing benefits and is often a desirable wound treatment. Unfortunately, NPWT devices are not widely available in low-resource settings (LRSs). In order to overcome identified NPWT barriers, a simplified NPWT (sNPWT) system was designed and iteratively improved during field-based testing. The sNPWT technology, our device design iterations, and the design-based results of our field tests are described. The sNPWT system includes a bellows hand pump, an occlusive drape, and a tube with tube connectors, connecting the drape to the pump. The most critical property of a sNPWT system is that it must be airtight. The details of the design iterations needed to achieve an occlusive system are explained. During the design process, the sNPWT system was tested during the earthquake relief in Haiti. This testing found that a liquid sealant was necessary to seal the drape to the peri-wound skin. A study conducted in Rwanda verified that a liquid latex sealant was safe to use and that the tube connector must be connected to the drape with an airtight method during the manufacturing process. This work has shown that sNPWT is feasible in LRSs. Since the completion of the clinical testing, the design has been further evolved and the developers are working with contract manufactures to produce the final design and preparing for regulatory approval applications.
机译:负压伤口疗法(NPWT)提供了已证实的伤口愈合益处,并且通常是理想的伤口疗法。不幸的是,NPWT设备在低资源设置(LRS)中并未广泛使用。为了克服已确定的NPWT障碍,设计了一个简化的NPWT(sNPWT)系统,并在基于现场的测试中对其进行了迭代改进。描述了sNPWT技术,我们的设备设计迭代以及现场测试的基于设计的结果。 sNPWT系统包括一个波纹管手动泵,一个封闭的盖布以及一个带有管接头的管,该管接头将盖布连接到泵上。 sNPWT系统的最关键特性是它必须是气密的。解释了实现封闭系统所需的设计迭代的细节。在设计过程中,对sNPWT系统进行了海地抗震救灾的测试。该测试发现必须使用液体密封剂将披巾密封到伤口周围的皮肤上。在卢旺达进行的一项研究证实,液态乳胶密封剂可以安全使用,并且在生产过程中必须使用气密方法将管接头连接到盖布上。这项工作表明,sNPWT在LRS中是可行的。自临床测试完成以来,设计得到了进一步发展,开发人员正在与合同制造商合作以生产最终设计并为监管批准申请做准备。

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