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一项通过新型聚氨酯泡沫对压疮进行负压伤口治疗的随机对照试验。

A randomized, controlled trial of negative pressure wound therapy of pressure ulcers via a novel polyurethane foam.

作者信息

Wagstaff Marcus James Dermot, Driver Sara, Coghlan Patrick, Greenwood John Edward

机构信息

Department of Plastic and Reconstructive Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

出版信息

Wound Repair Regen. 2014 Mar-Apr;22(2):205-11. doi: 10.1111/wrr.12146.

DOI:10.1111/wrr.12146
PMID:24635170
Abstract

The objectives of the study were (1) to look for any local, clinically apparent response, within and around a debrided wound, to a novel biocompatible polyurethane foam during repeated, short-term implantation, and (2) to assess the material's efficacy as a negative pressure wound therapy (NPWT) interface compared with a widely used, commercially available foam. Twenty pressure ulcers in 18 patients underwent surgical debridement, then randomization to receive novel treatment or control foam as the wound interface for NPWT. Dressing changes every 2-3 days allowed qualitative wound assessment and quantitative measurement to compare outcomes. No adverse reaction was observed in any patient receiving the new foam. The new "novel foam" performed as a NPWT interface as effectively as the control "standard foam." In deep wounds, the new foam was easier to remove, fragmented less, and showed less retention than the control foam. No marginal in-growth occurred, making removal less traumatic and reducing bleeding from cavity wall granulations. The results support previous large animal studies, and independent ISO10993 testing, that the new foam is safe and biocompatible. Its efficacy as an NPWT interface, nontraumatic removal with low fragmentation and retention rate, favors the new material, especially in deep cavity wounds.

摘要

本研究的目的是

(1)在反复短期植入过程中,观察清创伤口内部及周围对新型生物相容性聚氨酯泡沫的任何局部临床明显反应;(2)与广泛使用的市售泡沫相比,评估该材料作为负压伤口治疗(NPWT)界面的功效。18例患者的20处压疮接受了手术清创,然后随机分组,接受新型治疗泡沫或对照泡沫作为NPWT的伤口界面。每2 - 3天更换敷料,以便进行伤口定性评估和定量测量以比较结果。接受新泡沫的任何患者均未观察到不良反应。新型“新型泡沫”作为NPWT界面的效果与对照“标准泡沫”一样有效。在深部伤口中,新泡沫比对照泡沫更容易去除,破碎更少,残留更少。没有边缘向内生长,使得去除过程创伤更小,减少了腔壁肉芽组织的出血。结果支持先前的大型动物研究以及独立的ISO10993测试,即新泡沫是安全且生物相容的。其作为NPWT界面的功效、低破碎率和残留率的无创去除,有利于这种新材料,特别是在深部腔隙伤口中。

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