Hüging Martina, Biedermann Thomas, Sobrio Monia, Meyer Sarah, Böttcher-Haberzeth Sophie, Manuel Edith, Horst Maya, Hynes Sally, Reichmann Ernst, Schiestl Clemens, Hartmann-Fritsch Fabienne
From the *Pediatric Burn Center, Division of Plastic and Reconstructive Surgery, Department of Surgery, University Children's Hospital Zurich, Switzerland; †Children's Research Center, University Children's Hospital Zurich, Switzerland; ‡Tissue Biology Research Unit, Department of Surgery, University Children's Hospital Zurich, Switzerland; and §Department of Surgery, University Children's Hospital Zurich, Switzerland.
J Burn Care Res. 2017 Nov/Dec;38(6):354-364. doi: 10.1097/BCR.0000000000000530.
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 was 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™ (Kendall Medtronic, Minneapolis, USA), Suprathel (PolyMedics Innovations GmbH, Denkendorf, Germany), Urgotul SSD (Urgo Medical, Shepshed, United Kingdom), Mepilex AG (Mölnlycke Health Care, Gothenburg, Sweden), or Acticoat™ (Smith&Nephew, Baar, Switzerland). 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.
自体生物工程真皮-表皮皮肤替代物是治疗大面积皮肤缺损（如烧伤）的一种很有前景的方法。为了使其成功应用于临床，移植敷料必须保护和支持角质形成细胞层，并且在许多情况下具有抗菌特性。然而，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。我们研究的目的是评估各种伤口敷料对一种基于水凝胶的人真皮-表皮皮肤替代物愈合的影响，为首次人体临床试验做准备。在良好生产规范条件下生产出经临床试验批准的人真皮-表皮皮肤替代物，将其移植到免疫功能不全的大鼠身上，并用凡士林纱布（美国明尼阿波利斯肯德尔美敦力公司）、Suprathel（德国登肯多夫PolyMedics Innovations有限公司）、优拓SSD（英国谢普舍德Urgo Medical公司）、美皮康AG（瑞典哥德堡墨尼克医疗保健公司）或Acticoat（瑞士巴尔施乐辉公司）进行包扎。在移植后10天和21天对移植物进行临床评估，观察其存活、上皮化和感染情况，并在21天时进行组织学评估。凡士林纱布组和Suprathel组各有3只实验对象，优拓SSD组、美皮康AG组和Acticoat组各有4只实验对象。对于所有样本，存活率为100%，并观察到了预期的角质形成细胞数量、上皮化和表皮分层情况。我们的人真皮-表皮皮肤替代物对本研究中的所有敷料耐受性良好。鉴于大面积皮肤缺损存在细菌污染的高风险，银基敷料的耐受性尤为重要，并且在我们开展这种新型皮肤替代物的临床试验时提供了关键信息。
