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一项生物合成临时皮肤替代品Dermagraft-Transitional Covering与冷冻保存的人尸体皮肤用于切除烧伤创面临时覆盖的临床试验。

Clinical trials of a biosynthetic temporary skin replacement, Dermagraft-Transitional Covering, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds.

作者信息

Hansbrough J F, Mozingo D W, Kealey G P, Davis M, Gidner A, Gentzkow G D

机构信息

Department of Surgery, University of California, San Diego Medical Center 92103, USA.

出版信息

J Burn Care Rehabil. 1997 Jan-Feb;18(1 Pt 1):43-51. doi: 10.1097/00004630-199701000-00008.

DOI:10.1097/00004630-199701000-00008
PMID:9063787
Abstract

Human cadaver allograft skin (HCAS) is widely used for covering excised burn wounds when limited available skin donor sites or the overall patient condition does not permit immediate grafting with autologous skin. However, recurring problems are associated with HCAS including limited supply, variable quality, ultimate immune rejection, and the potential for bacterial and viral disease transmission. These problems speak for the need for development of a dependable substitute for HCAS. We evaluated the ability of a biosynthetic analogue of human skin to temporarily close excised burn wounds in humans. Dermagraft-TC (Advanced Tissue Sciences, Inc.) (DG-TC) is composed of human neonatal fibroblasts cultured on a synthetic dressing (Biobrane; Dow Hickam, Inc.) that consists of nylon mesh fabric covered with a thin layer of silicone rubber membrane, which provides an epidermal "barrier." The material is stored frozen and thawed immediately before use. DG-TC is semitransparent, thus facilitating continuous observation of the underlying wound surface. Burn wounds in 10 patients (mean age 33.5 years, mean burn size 39.9% total body surface area) were surgically excised. Two variants of the DG-TC skin analogs were tested: a material that was cryopreserved to maintain fibroblast viability (DG-TC Red) and a material that was frozen without efforts to maintain fibroblast viability (DG-TC Blue). A control site on each patient received cryopreserved HCAS. Each study site was approximately 1% total body surface area. When clinically indicated, patients were returned to the operating room where the skin replacements were removed, the wound bed was evaluated and prepared for grafting, and the wounds were closed with meshed split-thickness autograft skin. The results showed that adherence to the wound and subsequent autograft "take" were excellent with both DG-TC variants and were at least equivalent to HCAS. No evidence of immune rejection of DG-TC was seen, whereas in four patients evidence of epidermal sloughing/rejection was noted in the HCAS control sites, which limited persistence of those grafts on the wound. Further clinical trials with this skin analogue are in progress.

摘要

当可用的皮肤供区有限或患者整体状况不允许立即进行自体皮肤移植时,人尸体同种异体皮肤(HCAS)被广泛用于覆盖切除的烧伤创面。然而,HCAS存在一些反复出现的问题,包括供应有限、质量参差不齐、最终的免疫排斥反应以及细菌和病毒疾病传播的可能性。这些问题表明需要开发一种可靠的HCAS替代品。我们评估了一种人工合成皮肤类似物暂时闭合人类切除烧伤创面的能力。Dermagraft-TC(先进组织科学公司)(DG-TC)由在合成敷料(生物膜;陶氏希卡姆公司)上培养的人新生儿成纤维细胞组成,该敷料由覆盖有一层薄硅橡胶膜的尼龙网织物构成,可提供表皮“屏障”。该材料冷冻保存,使用前立即解冻。DG-TC是半透明的,因此便于持续观察创面底部。对10例患者(平均年龄33.5岁,平均烧伤面积占体表面积的39.9%)的烧伤创面进行手术切除。测试了两种DG-TC皮肤类似物变体:一种通过冷冻保存以维持成纤维细胞活力的材料(DG-TC红色)和一种未采取措施维持成纤维细胞活力而冷冻的材料(DG-TC蓝色)。每位患者的一个对照部位接受冷冻保存的HCAS。每个研究部位约占体表面积的1%。当临床指征明确时,患者返回手术室,去除皮肤替代物,评估并准备创面床以供移植,然后用网状分层自体皮封闭创面。结果表明,两种DG-TC变体对创面的粘附以及随后自体皮的“成活”情况都非常好,且至少与HCAS相当。未观察到DG-TC有免疫排斥的迹象,而在4例患者的HCAS对照部位发现了表皮脱落/排斥的迹象,这限制了这些移植物在创面上的存留时间。这种皮肤类似物的进一步临床试验正在进行中。

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