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一项比较软性硅胶涂层伤口接触层(Mepitel One)与脂质水胶体伤口接触层(UrgoTul)在急性伤口治疗中的表现的随机、对照、非劣效性试验。

A randomised, controlled, non-inferiority trial comparing the performance of a soft silicone-coated wound contact layer (Mepitel One) with a lipidocolloid wound contact layer (UrgoTul) in the treatment of acute wounds.

机构信息

Verzy, France.

ResearchLink France, Mundolsheim, France.

出版信息

Int Wound J. 2018 Feb;15(1):159-169. doi: 10.1111/iwj.12853. Epub 2017 Dec 5.

Abstract

Wound contact layer (WCL) dressings are intended to protect tissue during the healing process. A randomised controlled trial was undertaken to compare 2 such dressings. Outpatients with acute wounds were randomly allocated to treatment with either a soft silicone-coated WCL (intervention group, n = 59) or a lipidocolloid-impregnated WCL (control group, n = 62). At the first dressing removal (day 3), 89.8% of patients in the intervention group experienced non-painful dressing removal (defined as a pain rating <30 mm on a 100 mm visual analogue scale), compared with 73.6% of patients in the control group (P = .017) (per protocol population). At day 21, wounds were considered as healed in 66.1% of patients in the intervention group compared with 43.5% in the control group (P = .012) (intention-to-treat population). Both dressings were well tolerated and rated highly in terms of in-use characteristics, although the soft silicone-coated WCL was rated significantly higher than the lipidocolloid-impregnated WCL in terms of its ability to remain in place (P= .016). The results indicate that the soft silicone-coated WCL is suitable for the management of acute wounds as it can minimise dressing-associated pain and support healing.

摘要

伤口接触层 (WCL) 敷料旨在保护组织在愈合过程中。一项随机对照试验比较了两种这样的敷料。将急性伤口的门诊患者随机分配到软硅胶涂层 WCL(干预组,n=59)或脂质胶体浸渍 WCL(对照组,n=62)治疗。在第一次换药(第 3 天)时,干预组 89.8%的患者经历了无痛换药(定义为疼痛评分<30mm 的 100mm 视觉模拟量表),而对照组为 73.6%(P=0.017)(按方案人群)。在第 21 天,干预组 66.1%的患者伤口被认为已经愈合,而对照组为 43.5%(P=0.012)(意向治疗人群)。两种敷料均耐受性良好,在使用特性方面评分很高,尽管软硅胶涂层 WCL在保持原位方面的能力明显优于脂质胶体浸渍 WCL(P=0.016)。结果表明,软硅胶涂层 WCL 适合管理急性伤口,因为它可以最大程度地减少与敷料相关的疼痛并支持愈合。

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Wound treatment and pain management: a stressful time.伤口治疗与疼痛管理:一段压力重重的时期。
Int Wound J. 2013 Dec;10(6):638-44. doi: 10.1111/j.1742-481X.2012.01038.x. Epub 2012 Aug 21.

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