Wainwright D, Madden M, Luterman A, Hunt J, Monafo W, Heimbach D, Kagan R, Sittig K, Dimick A, Herndon D
Department of Plastic Surgery, University of Texas Health Science Center, Houston 77030, USA.
J Burn Care Rehabil. 1996 Mar-Apr;17(2):124-36. doi: 10.1097/00004630-199603000-00006.
A multicenter clinical study assessed the ability of an acellular allograft dermal matrix to function as a permanent dermal transplant in full-thickness and deep partial-thickness burns. The study consisted of a pilot phase (24 patients) to identify the optimum protocol and a study phase (43 patients) to evaluate graft performance. Each patient had both a test and a mirror-image or contiguous control site. At the test site, the dermal matrix was grafted to the excised wound base and a split-thickness autograft was simultaneously applied over it. The control site was grafted with a split-thickness autograft alone. Fourteen-day take rates of the dermal matrix were statistically equivalent to the control autografts. Histology of the dermal matrix showed fibroblast infiltration, neovascularization, and neoepithelialization without evidence of rejection. Wound assessment over time showed that thin split-thickness autografts plus allograft dermal matrix were equivalent to thicker split-thickness autografts.
一项多中心临床研究评估了脱细胞异体真皮基质作为全层和深部部分厚度烧伤永久性真皮移植材料的功能。该研究包括一个试点阶段(24例患者)以确定最佳方案,以及一个研究阶段(43例患者)以评估移植效果。每位患者都有一个测试部位和一个镜像或相邻的对照部位。在测试部位,将真皮基质移植到切除后的创面基底上,并同时在其上覆盖一层薄断层自体皮片。对照部位仅移植薄断层自体皮片。真皮基质的14天成活率在统计学上与对照自体皮片相当。真皮基质的组织学检查显示有成纤维细胞浸润、新生血管形成和新上皮形成,且无排斥反应迹象。随时间进行的创面评估表明,薄断层自体皮片加异体真皮基质与较厚的薄断层自体皮片效果相当。