■几乎没有整个网状真皮层是使用自体裂层皮肤移植(STSG)封闭全层伤口所固有的,常导致肥厚性疤痕和挛缩。已经开发了许多真皮替代品,但不幸的是,大多数在美容和/或功能改善以及患者满意度方面都有不同的结果,除了高成本。据报道,使用人来源的甘油化的无细胞真皮(Glyaderm®)的双层皮肤重建使用两步程序导致显著改善的瘢痕质量。与大多数市售真皮替代品的必要两步程序不同,在这项研究中,我们旨在研究Glyaderm®在更具成本效益的单阶段移植中的使用。这是一种方法,如果有自体移植物,考虑到成本的降低,是大多数外科医生的首选,住院时间和感染率。
■预期,随机化,控制,个体内部,进行了单盲研究,调查Glyaderm®和STSG的同时应用与仅STSG可用于全层烧伤或类似的深层皮肤缺损。在急性期,细菌负荷,我们评估了移植时间和伤口闭合时间,是主要结局.使用主观和客观瘢痕测量工具在3、6、9和12个月随访时评估美学和功能结果(次要结果)。在3个月和12个月时进行活检以进行组织学分析。
■共包括66名患者,代表82个伤口比较。移植(>95%),两组的疼痛管理和愈合时间具有可比性.随访1年,患者评估的总体患者和观察者疤痕评估量表显著有利于使用Glyaderm®的场所.不经常,患者将这种差异归因于皮肤感觉的改善。组织学分析显示存在形成良好的新真皮,供体弹性蛋白存在长达12个月。
■使用Glyaderm®和STSG进行的单阶段双层重建可获得最佳的移植物,而不会因感染而损失Glyaderm®或重叠的自体移植物。在长期随访中,除一名患者外,所有患者都证实了弹性蛋白在新真皮中的存在。这是致盲患者评估的显著改善整体瘢痕质量的关键因素。
■该试验已在clinicaltrials.gov上注册,并获得以下注册码:NCT01033604。
UNASSIGNED: Absence of almost the entire reticular dermal layer is inherent to the use of autologous split-thickness skin grafting (STSG) to close full-thickness wounds, often resulting in hypertrophic scars and contractures. Many dermal substitutes have been developed, but unfortunately most have varying results in terms of cosmetic and/or functional improvement as well as patient satisfaction, in addition to high costs. Bilayered skin reconstruction using the human-derived glycerolized acellular dermis (Glyaderm®) has been reported to result in significantly improved scar quality using a two-step procedure. Unlike the necessary two-step procedure for most commercially available dermal substitutes, in this study we aimed to investigate the use of Glyaderm® in a more cost-effective single-stage engrafting. This is a method which, if autografts are available, is preferred by the majority of surgeons given the reduction in costs, hospitalization time and infection rate.
UNASSIGNED: A prospective, randomized, controlled, intra-individual, single-blinded study was performed, investigating the simultaneous application of Glyaderm® and STSG vs. STSG alone in full-thickness burns or comparable deep skin defects. During the acute phase, bacterial load, graft take and time to wound closure were assessed and were the primary outcomes. Aesthetic and functional results (secondary outcomes) were evaluated at 3, 6, 9 and 12 months follow-up using subjective and objective scar measurement tools. Biopsies for histological analysis were taken at 3 and 12 months.
UNASSIGNED: A total of 66 patients representing 82 wound comparisons were included. Graft take (>95%), pain management and healing time were comparable in both groups. At 1 year follow-up, the overall Patient and Observer Scar Assessment Scale assessed by the patient was significantly in favour of sites where Glyaderm® was used. Not infrequently, patients attributed this difference to improved skin sensation. Histological analysis showed the presence of a well-formed neodermis, with donor elastin present for up to 12 months.
UNASSIGNED: A single-stage bilayered reconstruction with Glyaderm® and STSG results in optimal graft take without loss of Glyaderm® nor the overlaying autografts due to infection. The presence of elastin in the neodermis was demonstrated during long-term follow-up in all but one patient, which is a crucial factor contributing to the significantly improved overall scar quality as evaluated by the blinded patients.
UNASSIGNED: The trial was registered on clinicaltrials.gov and received the following registration code: NCT01033604.