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一项比较性结局分析,评估两种不同人胎盘膜产品用于伤口管理的临床有效性。

A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management.

作者信息

Johnson Eric L, Marshall James T, Michael Georgina M

机构信息

Bozeman Health Deaconess Hospital, Wound and Hyperbaric Center, Bozeman, Montana, and.

Osiris Therapeutics, Inc., Columbia, Maryland.

出版信息

Wound Repair Regen. 2017 Jan;25(1):145-149. doi: 10.1111/wrr.12503. Epub 2017 Jan 19.

Abstract

Advances in tissue preservation have led to the commercialization of human placental membranes for the purposes of wound management with each product being characterized by different compositions and properties. The a priori specification of the research question in this investigator-initiated study focused on the clinical outcomes in two nonrandomized, however statistically equal and homogenous patient cohorts receiving either a viable intact cryopreserved human placental membrane (vCPM) or a dehydrated human amnion/chorion membrane (dHACM), for the management of wounds at a single center. A total of 79 patients with 101 wounds were analyzed: 40 patients with 46 wounds received vCPM and 39 patients with 55 wounds received dHACM. The proportion of wounds achieving complete wound closure was 63.0% (29/46) for vCPM and 18.2% (10/55) for dHACM (p < 0.0001) for all treated wounds combined. This is the first comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting.

摘要

组织保存技术的进步已促使用于伤口处理的人胎盘膜实现商业化,每种产品都具有不同的成分和特性。在这项由研究者发起的研究中,研究问题的先验规范聚焦于两个非随机但在统计学上相等且同质的患者队列的临床结局,这两个队列分别接受了用于单中心伤口处理的活的完整冷冻保存人胎盘膜(vCPM)或脱水人羊膜/绒毛膜(dHACM)。总共对79例患者的101处伤口进行了分析:40例患者的46处伤口接受了vCPM治疗,39例患者的55处伤口接受了dHACM治疗。对于所有接受治疗的伤口,vCPM实现完全伤口闭合的伤口比例为63.0%(29/46),dHACM为18.2%(10/55)(p < 0.0001)。这是第一项关于不同胎盘伤口护理产品在临床环境中广泛应用后相关临床结局的比较有效性研究。

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