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首页> 美国卫生研究院文献>Eplasty >Healing Rates in a Multicenter Assessment of a Sterile Room Temperature Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers
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Healing Rates in a Multicenter Assessment of a Sterile Room Temperature Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers

机译：无菌室温无细胞真皮基质与常规护理伤口管理以及有源比较器在全厚度糖尿病足溃疡治疗中的多中心评估中的治愈率

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>Objective: The purpose of this 16-week, multicenter, randomized, controlled trial was to assess the healed ulcer rate of a human acellular dermal matrix, DermACELL, compared with conventional care and a second acellular dermal matrix, Graftjacket, in the treatment of full-thickness diabetic foot ulcers. >Methods: One hundred sixty-eight patients were randomized into DermACELL, conventional care, and Graftjacket treatment arms in a 2:2:1 ratio. Patients in the acellular dermal matrix groups received either 1 or 2 applications of the graft at the discretion of the investigator. Weekly follow-up visits were conducted until the ulcer healed or the endpoint was reached. >Results: At 16 weeks, the DermACELL arm had a significantly higher proportion of completely healed ulcers than the conventional care arm (67.9% vs 48.1%; P = .0385) and a nonsignificantly higher proportion than the Graftjacket arm (67.9% vs 47.8%; P = .1149). The DermACELL arm also exhibited a greater average percent reduction in wound area than the conventional care arm (91.4% vs 80.3%; P = .0791) and the Graftjacket arm (91.4% vs 73.5%; P = .0762). The proportion of severe adverse events and the proportion of overall early withdrawals were similar among the 3 groups based on relative population size (P ≥ .05). >Conclusions: The results presented here indicate that DermACELL is an appropriate clinical option in the treatment of diabetic foot ulcers, with significant increases in healing rates and rate of percentage wound closure as compared with conventional care options.
机译：>目的：这项为期16周的多中心随机对照试验旨在评估人脱细胞真皮基质DermACELL与常规护理和第二种脱细胞真皮基质相比的溃疡愈合率， Graftjacket，用于治疗全层糖尿病足溃疡。 >方法：将168例患者按2：2：1的比例随机分为DermACELL，常规护理和Graftjacket治疗组。根据研究者的判断，无细胞真皮基质组的患者接受1或2次移植。每周进行一次随访，直至溃疡愈合或达到终点。 >结果：在第16周时，DermACELL臂完全治愈的溃疡比例明显高于传统护理臂（67.9％比48.1％； P = .0385），并且比Graftjacket的比例显着更高手臂（67.9％vs 47.8％； P = .1149）。与传统护理臂（91.4％比80.3％； P = .0791）和Graftjacket臂（91.4％比73.5％； P = .0762）相比，DermACELL臂的伤口面积平均减少率更高。根据相对人口规模，三组中的严重不良事件比例和总的早期退出比例相似（P≥.05）。 >结论：此处显示的结果表明，DermACELL是治疗糖尿病足溃疡的合适临床选择，与传统护理相比，其治愈率和伤口闭合率显着提高。

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