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简易负压伤口治疗:一种超便携无罐系统的临床评估

Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system.

作者信息

Hudson Donald A, Adams Kevin G, Van Huyssteen Adriaan, Martin Robin, Huddleston Elizabeth M

机构信息

Department of Plastic and Reconstructive Surgery, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.

出版信息

Int Wound J. 2015 Apr;12(2):195-201. doi: 10.1111/iwj.12080. Epub 2013 May 7.

Abstract

The aim of this study was to evaluate a prototype negative pressure wound therapy (NPWT) system that has been developed to simplify NPWT for wounds at the lower end of the acuity scale. The new device has a single preset pressure of -80 mmHg, is single use and operates without an exudate canister. The disposable NPWT system (PICO™) was tested in a prospective, non-comparative, multicentre clinical trial to assess device functionality and clinical acceptance. Twenty patients were recruited for a maximum treatment period of 14 days. The NPWT devices were fitted with data log chips to enable longitudinal assessment of negative pressure and leak rates during therapy. Sixteen (80%) patients had closed surgical wounds, two (10%) patients had traumatic wounds and two (10%) patients received meshed split thickness skin grafts. The mean study duration was 10·7 days (range: 5-14 days) and the mean dressing wear time per individual patient was 4·6 days (range: 2-11). Fifty-five percent of wounds had closed by the end of the 14-day study or earlier, with a further 40% of wounds progressing to closure. Real-time pressure monitoring showed continuous delivery of NPWT. Three cases are discussed representing different wound locations and different patient factors that can increase the risk of post-surgical complications. Clinical studies of the disposable NPWT system confirmed the ability of the simplified single-use device to function consistently over the expected wear time. The anticipated reduced costs, ease of use and increased mobility of patients using this system may enable NPWT benefits to be available to a greater proportion of patients.

摘要

本研究的目的是评估一种负压伤口治疗(NPWT)原型系统,该系统旨在简化针对低 acuity 分级伤口的 NPWT。新设备具有 -80 mmHg 的单一预设压力,为一次性使用,且无需渗出液收集罐。一次性 NPWT 系统(PICO™)在一项前瞻性、非对照、多中心临床试验中进行了测试,以评估设备功能和临床接受度。招募了 20 名患者,最长治疗期为 14 天。NPWT 设备配备了数据记录芯片,以便在治疗期间对负压和泄漏率进行纵向评估。16 名(80%)患者的手术伤口已愈合,2 名(10%)患者有创伤性伤口,2 名(10%)患者接受了网状分层皮片移植。平均研究持续时间为 10.7 天(范围:5 - 14 天),每位患者的平均敷料佩戴时间为 4.6 天(范围:2 - 11)。在为期 14 天的研究结束时或更早,55%的伤口已愈合,另有 40%的伤口正在愈合。实时压力监测显示 NPWT 持续输送。讨论了 3 个病例,代表不同的伤口部位和可能增加术后并发症风险的不同患者因素。一次性 NPWT 系统的临床研究证实了这种简化的一次性设备在预期佩戴时间内持续发挥功能的能力。使用该系统预期的成本降低、易用性提高以及患者活动能力增强,可能使更多患者受益于 NPWT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f5c/7950749/aec9086f3dba/IWJ-12-195-g001.jpg

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