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The effect of wound dressings on a bio-engineered human dermo-epidermal skin substitute in a rat model

机译:伤口敷料对大鼠模型中生物工程人皮肤-表皮皮肤替代物的影响

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摘要

Autologous bio-engineered dermo-epidermal skin substitutes are a promising treatment for large skin defects such as burns. For their successful clinical application, the graft dressing must protect and support the keratinocyte layer and, in many cases, possess antimicrobial properties. However, silver in many antimicrobial dressings may inhibit keratinocyte growth and differentiation. The purpose of our study is to evaluate the effect of various wound dressings on the healing of a human hydrogel-based dermo-epidermal skin substitute in preparation for the first-in-human clinical trials. Human dermo-epidermal skin substitutes approved for clinical trials were produced under good manufacturing practice conditions, transplanted onto immuno-incompetent rats, and dressed with either Vaseline Gauze™, Suprathel®, Urgotul® SSD, Mepilex® AG, or Acticoat™. Grafts were assessed clinically for take, epithelialization, and infection at 10 and 21 days post-transplantation, and histologically at 21 days. There were three subjects each in the Vaseline Gauze™ and Suprathel® groups, and four subjects each in the Urgotul® SSD, Mepilex® AG, and Acticoat™ groups. For all samples, the take rate was 100% and the expected keratinocyte number, epithelialization and epidermal stratification were observed. All of the dressings in the current study were well tolerated by our human dermo-epidermal skin substitute. The tolerance of the silver-based dressings is particularly relevant given the high risk of bacterial contamination with large skin defects, and provides pivotal information as we embark on clinical trials for this novel skin substitute.
机译:自体生物工程真皮-表皮皮肤替代品是治疗大面积皮肤缺陷(如烧伤)的有前途的治疗方法。对于其成功的临床应用,移植物敷料必须保护和支撑角质形成细胞层,并且在许多情况下具有抗菌特性。但是,许多抗菌敷料中的银可能会抑制角质形成细胞的生长和分化。我们的研究目的是评估各种伤口敷料对基于人水凝胶的真皮表皮皮肤替代品愈合的影响,以准备进行首次人类临床试验。经批准用于临床试验的人真皮表皮皮肤替代品是在良好的生产实践条件下生产的,移植到免疫功能不全的大鼠上,并穿着Vaseline Gauze™,Suprathel®,Urgotul®SSD,Mepilex®AG或Acticoat™穿戴。在移植后第10天和第21天对移植物进行摄取,上皮化和感染的临床评估,并在第21天进行组织学评估。 Vaseline Gauze™和Suprathel®组各有3名受试者,Urgotul®SSD,Mepilex®AG和Acticoat™组各有4名受试者。对于所有样品,摄取率为100%,并且观察到了预期的角质形成细胞数,上皮化和表皮分层。本研究中的所有敷料均被我们的人类真皮-表皮皮肤替代品很好地耐受。鉴于细菌污染和较大皮肤缺陷的高风险,银基敷料的耐受性尤为重要,并在我们开始进行这种新型皮肤替代品的临床试验时提供了关键信息。

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