Background 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. Methods 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. Results 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. Conclusions 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. Trial registration The trial was registered on clinicaltrials.gov and received the following registration code: NCT01033604.

中文翻译：

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使用 Glyaderm® 作为脱细胞真皮再生模板的单阶段双层皮肤重建可改善疤痕质量：个体内随机对照试验

背景 几乎整个网状真皮层的缺失是使用自体分层皮肤移植 (STSG) 来闭合全层伤口所固有的，通常会导致增生性疤痕和挛缩。已经开发了许多真皮替代品，但不幸的是，除了高成本之外，大多数替代品在美容和/或功能改善以及患者满意度方面的结果各不相同。据报道，使用人源甘油化脱细胞真皮 (Glyaderm®) 进行的双层皮肤重建可通过两步程序显着改善疤痕质量。与大多数市售真皮替代品的必要两步程序不同，在本研究中，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，如果可以进行自体移植，考虑到成本、住院时间和感染率的降低，大多数外科医生更喜欢自体移植。方法 进行了一项前瞻性、随机、对照、个体内、单盲研究，研究同时应用 Glyaderm® 和 STSG 与单独使用 STSG 治疗全层烧伤或类似的深部皮肤缺损。在急性期，评估了细菌负荷、移植物使用量和伤口闭合时间，这些都是主要结果。使用主观和客观疤痕测量工具在 3、6、9 和 12 个月的随访中评估美学和功能结果（次要结果）。在 3 个月和 12 个月时进行组织学分析活检。结果 总共包括代表 82 个伤口比较的 66 名患者。接枝率（>95%），两组的疼痛管理和愈合时间相当。在 1 年的随访中，患者评估的整体患者和观察者瘢痕评估量表明显支持使用 Glyaderm® 的部位。患者经常将这种差异归因于皮肤感觉的改善。组织学分析显示存在结构良好的新真皮，供体弹性蛋白存在长达 12 个月。结论 使用 Glyaderm® 和 STSG 的单阶段双层重建可获得最佳移植物，而不会因感染而丢失 Glyaderm® 或覆盖的自体移植物。在除一名患者外的所有患者的长期随访期间，都证明了新真皮中存在弹性蛋白，这是导致盲法患者评估的整体疤痕质量显着改善的关键因素。