Abstract：
The objective of this study was to analyze, in a randomized controlled multicenter trial, whether a xenogeneic collagen matrix (XCM) could be used to cover skin defects. Patients with the need for skin excisions were recruited and randomized to treatment with a skin graft after a period of granulation or to treatment with an XCM. The results were evaluated by two independent observers on the Patient and Observer Scar Assessment Scale. On this scale, scars are ranked from 1 to 10 in six different categories. Results range from 6 to 60, with lower scores representing scars closer to normal skin. The results 6 months after reconstruction were used as primary endpoint and compared in a non-inferiority approach. A total of 39 wounds in the head and neck region were analyzed. The mean results were 16.55 (standard deviation 6.8) for XCM and 16.83 (standard deviation 8.21) in the control group. The result of the XCM was not significantly inferior to the result of the skin graft (p = 0.91). Within the limitations of the study, it seems that the use of xenogeneic collagen matrices is a viable alternative to other approaches in small skin defects, and therefore should be taken into account whenever the reduction of patient morbidity to a minimum is the priority. TRIAL REGISTRATION: This trial was registered in the German Clinical Trials Register under registration identification number DRKS00010930 and can be found under the following URLs: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010930. https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00010930.
摘要：
这项研究的目的是分析，在一项随机对照多中心试验中，异种胶原基质（XCM）是否可用于覆盖皮肤缺损。招募需要皮肤切除的患者，并在肉芽形成一段时间后随机接受皮肤移植物治疗或用XCM治疗。结果由两名独立的观察者在患者和观察者疤痕评估量表上进行评估。在这个尺度上,疤痕在六个不同的类别中从1到10排名。结果范围从6到60，较低的分数代表疤痕更接近正常皮肤。将重建后6个月的结果作为主要终点，并以非劣效性方法进行比较。分析了头部和颈部区域的总共39个伤口。XCM的平均结果为16.55（标准偏差6.8），对照组为16.83（标准偏差8.21）。XCM的结果并没有明显劣于皮肤移植的结果（p=0.91）。在研究的局限性内，似乎使用异种胶原蛋白基质是其他方法在小皮肤缺陷的可行替代方案，因此，每当将患者发病率降低到最低限度时，都应优先考虑。试验注册：该试验已在德国临床试验注册簿中注册，注册标识号为DRKS00010930，可以在以下URL中找到：https://www。drks.de/drks_web/navigate。做什么？navigationId=审判。HTML&TRIAL_ID=DRKS00010930。https://trialsearch.谁。int/Trial2。aspx?试验ID=DRKS00010930。
