Fong Kenton D, Hu Dean, Eichstadt Shaundra L, Gorell Emily, Munoz Claudia A, Lorenz H Peter, Chang Anne Lynn S
Director of Dermatological Clinical Trials, Department of Dermatology, Stanford University School of Medicine, Redwood City, California; Email;
Wounds. 2010 Sep;22(9):230-6.
Background. Traditional negative pressure wound therapy (NPWT) devices, such as the electrically powered V.A.C.® Therapy System (KCI, San Antonio, TX), are important tools in the treatment of both acute and chronic wounds. The following describes the first clinical experience using a novel, non-electrically powered, ultraportable NPWT device called the Smart Negative Pressure (SNaP™) Wound Care System (Spiracur, Sunnyvale, CA).
Twelve consecutive adult subjects with chronic wounds ranging from neuropathic wounds to venous stasis ulcers were treated with the SNaP System at an academic outpatient dermatology clinic. Subjects were followed biweekly for complications and wound healing progression over a 4-week period.
Of the 12 subjects treated, 5 achieved complete wound healing within 4 weeks. All subjects demonstrated healing after treatment with the SNaP System, and statistically significant healing was reached at 4 weeks (P < 0.01) for patients who were able to complete the treatment protocol. Use of the SNaP System promoted cleaner wound beds with robust granulation tissue formation. There were no serious adverse events directly related to the device. The most common complaint was mild or moderate wound pain in 3 of 12 subjects.
These findings support the safety and potential clinical utility of a new ultraportable NPWT device for the treatment of chronic wounds. .
背景。传统的负压伤口治疗(NPWT)设备,如电动的V.A.C.®治疗系统(KCI,圣安东尼奥,德克萨斯州),是治疗急性和慢性伤口的重要工具。以下描述了首次使用一种新型的、非电动的、超便携式NPWT设备——智能负压(SNaP™)伤口护理系统(Spiracur,森尼韦尔,加利福尼亚州)的临床经验。
在一家学术门诊皮肤科诊所,对12名患有从神经性伤口到静脉淤滞性溃疡等慢性伤口的成年受试者连续使用SNaP系统进行治疗。在4周的时间里,每两周对受试者进行一次随访,观察并发症和伤口愈合进展情况。
在接受治疗的12名受试者中,5人在4周内实现了伤口完全愈合。所有受试者在使用SNaP系统治疗后均显示出愈合情况,对于能够完成治疗方案的患者,在4周时达到了具有统计学意义的愈合(P < 0.01)。使用SNaP系统促进了伤口床更清洁,并形成了旺盛的肉芽组织。没有与该设备直接相关的严重不良事件。最常见的主诉是12名受试者中有3人出现轻度或中度伤口疼痛。
这些发现支持了一种新型超便携式NPWT设备用于治疗慢性伤口的安全性和潜在临床效用。