一项关于无泡沫或纱布负压装置用于皮肤和软组织缺损的前瞻性、对照、随机临床研究。

A Prospective, Controlled, Randomised, Clinical Study of Negative Pressure Device Without Foam or Gauze for Skin and Soft Tissue Defects.

作者信息

Nuutila Kristo, Diaz Victoria, Anselmo Kristin, Broomhead Michael, Eriksson Elof, Chan Rodney K

机构信息

United States Army Institute of Surgical Research, JBSA Fort Sam Houston, Texas, USA.

Metis Foundation, San Antonio, Texas, USA.

出版信息

Int Wound J. 2025 May;22(5):e70144. doi: 10.1111/iwj.70144.

Abstract

All common negative pressure wound therapy (NPWT) systems include a filler material usually foam or gauze at the wound/device interface. The filler material distributes the negative pressure evenly to all parts of the wound. The foam or gauze may fragment contributing to foreign material being retained in the wound, becoming colonised with bacteria over time, and painful dressing changes. To mitigate these, negative aspects, an impermeable embossed single-layer NPWT membrane dressing has been developed. The dressing has been coined Negative Pressure-Platform Wound Device (NP-PWD) and a foam or gauze is not required to deliver negative pressure. Rather, the pressure is permeated via the spaces between the embossed pyramids and the wrinkles in the membrane. The purpose of this study was to compare the NP-PWD to the standard of care (SOC) NPWT system in the treatment of skin and soft tissue defects. This was a prospective, randomised, controlled clinical trial. The wounds were treated with the NP-PWD or SOC NPWT system. The randomised treatment was applied for 2 days to up to 9 days after the initial application. Follow-up data were collected at each dressing change/removal and included photographs, and assessments for wound healing, infection, and adverse events. In total 24 subjects (12 NP-PWD and 12 SOC) completed the study. The NP-PWD was easy to use and fast to apply and the patients tolerated it well. The transparency of the NP-PWD allowed the provider to see the wound without removing the dressing which is an improvement over traditional NPWT. In terms of wound healing, inflammation, pain, and infection, no differences were observed between the NP-PWD and the SOC NPWT system. The NP-PWD is a simplified, single component NPWT system eliminating the use of the filler material that commonly causes challenges during treatment.

摘要

所有常见的负压伤口治疗(NPWT)系统在伤口与装置的界面处都包含一种填充材料,通常是泡沫或纱布。填充材料将负压均匀地分布到伤口的各个部位。泡沫或纱布可能会破碎,导致异物残留在伤口中,随着时间的推移被细菌定植,从而使换药变得痛苦。为了减轻这些负面影响,已开发出一种不可渗透的压纹单层NPWT膜敷料。这种敷料被称为负压平台伤口装置(NP-PWD),不需要泡沫或纱布来传递负压。相反,压力是通过压纹金字塔之间的空隙和膜中的褶皱渗透的。本研究的目的是比较NP-PWD与标准护理(SOC)NPWT系统在治疗皮肤和软组织缺损方面的效果。这是一项前瞻性、随机、对照临床试验。伤口用NP-PWD或SOC NPWT系统进行治疗。随机治疗在初次应用后持续2天至9天。在每次换药/移除时收集随访数据,包括照片,以及对伤口愈合、感染和不良事件的评估。共有24名受试者(12名使用NP-PWD,12名使用SOC)完成了研究。NP-PWD易于使用且应用迅速,患者耐受性良好。NP-PWD的透明性使医护人员在不拆除敷料的情况下就能看到伤口,这是相对于传统NPWT的一个改进。在伤口愈合、炎症、疼痛和感染方面,NP-PWD与SOC NPWT系统之间未观察到差异。NP-PWD是一种简化的单组分NPWT系统,省去了在治疗过程中通常会带来挑战的填充材料的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5469/12050212/ef8bc43c6a8d/IWJ-22-e70144-g001.jpg

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