Healing Rate and Autoimmune Safety of Full-Thickness Wounds Treated With Fish Skin Acellular Dermal Matrix Versus Porcine Small-Intestine Submucosa: A Noninferiority Study
Healing Rate and Autoimmune Safety of Full-Thickness Wounds Treated With Fish Skin Acellular Dermal Matrix Versus Porcine Small-Intestine Submucosa: A Noninferiority Study
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DOI：
10.1177/1534734615573661
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发表时间：
2015-03-01
影响因子：
1.7
通讯作者：
Lund, Sigrun Helga
中科院分区：
文献类型：
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作者：
Baldursson, Baldur Tumi;Kjartansson, Hilmar;Lund, Sigrun Helga
鱼皮脱细胞真皮基质（ADM）是近年来出现的一种新产品，已被引入到治疗创伤的生物材料家族中。目前，这些产品是从牲畜的器官中生产出来的。采用非劣效性检验比较鱼皮ADM对81名志愿者前臂162个全层4 mm伤口愈合的猪小肠粘膜下层细胞外基质的作用。在主要终点，鱼皮产品是非劣效的，在28天愈合。此外，用鱼皮脱细胞基质治疗的伤口愈合明显更快。这些结果可能会给鱼皮ADM的优势，因为它的环境中性相比，畜牧产品。这些急性全层伤口的研究结果可能适用于糖尿病足溃疡和其他慢性全层伤口，鱼皮治疗组的愈合时间较短可能会影响治疗决策。为了测试鱼皮的自身免疫反应性，用以下ELISA（酶联免疫吸附测定）测试参与者：RF、ANA、ENA、抗ds-DNA、ANCA、抗CCP和抗胶原I和II。这些显示无反应性。结果证实了鱼皮ADM用于伤口护理的安全性和有效性。
A novel product, the fish skin acellular dermal matrix (ADM) has recently been introduced into the family of biological materials for the treatment of wounds. Hitherto, these products have been produced from the organs of livestock. A noninferiority test was used to compare the effect of fish skin ADM against porcine small-intestine submucosa extracellular matrix in the healing of 162 full-thickness 4-mm wounds on the forearm of 81 volunteers. The fish skin product was noninferior at the primary end point, healing at 28 days. Furthermore, the wounds treated with fish skin acellular matrix healed significantly faster. These results might give the fish skin ADM an advantage because of its environmental neutrality when compared with livestock-derived products. The study results on these acute full-thickness wounds might apply for diabetic foot ulcers and other chronic full-thickness wounds, and the shorter healing time for the fish skin-treated group could influence treatment decisions. To test the autoimmune reactivity of the fish skin, the participants were tested with the following ELISA (enzyme-linked immunosorbent assay) tests: RF, ANA, ENA, anti ds-DNA, ANCA, anti-CCP, and anticollagen I and II. These showed no reactivity. The results demonstrate the claims of safety and efficacy of fish skin ADM for wound care.