组织工程复合皮肤应用于皮肤缺损创面的临床疗效观察

目的:临床观察组织工程复合皮肤对烧伤整形后需植皮患者的供皮区缺损创面的有效性及安全性。方法:试验选取不同临床中心烧伤整形后需植皮患者,在供皮区部分创面作为试验区应用组织工程复合皮肤覆盖,邻近创面采用盐水纱布替代作为对照区,应用后按常规方法包扎固定。临床试验时间为6个月,治疗期间观察统计患者的创面反应,愈合时间及愈合情况;对组织工程复合皮肤改善创面愈合质量及安全性进行临床评估。根据创面试验组和对照组的创面愈合时间,应用SPSS统计软件对数据进行方差齐性检验,根据检验结果分别进行独立样本t或t’检验。结果:试验共收集有效病例19例。临床观察显示应用后试验区创面无明显免疫排斥及炎性反应,患者自述疼痛明显减轻,试验区创面愈合时间与对照区相比缩短8d,统计学分析有显著性差异。愈后随访部分患者试验区愈合质量好于对照区,应用后患者疼痛、瘢痕形成等不良反应明显减少。结论:结果表明组织工程复合皮肤作为活型皮肤替代物用于医源性皮肤缺损的修复,这为促进供皮区的创面愈合提供了切实可行的方法。

Clinical Effect Assessment of Tissue-engineered Composite Skin on the Donor Site Defect Wound

Objective:To investigate the clinical effect and safety of tissue engineered composite skin on the donor site wound. Method:Partial wound of patients from multi-clinical center were treated with tissue engineered composite skin,and the adjacent wound were treated with standard method as control site.The data including reaction of wound,healing time and cosmetic outcome were recorded during 6-month to explore the role of tissue engineered skin in improving the quality of regenerated skin.The difference of average healing time between experimental site and control site was analyzed with SPSS software.Results:In 19 effective cases,there were no obvious adverse events such as immunological rejection and inflammatory reaction on the wound when treated with TE skin. The average healing time of activskin treated wounds significantly decreased by about 8 day compared with the control site.The cosmetic outcome of regeneration skin was much better than the control site.Conclusion:These results suggested that activskin is a new bioactive skin substitute for the repair of skin defect.The application of tissue engineered composite skin has provided a practical and effective method to promote the healing of wound on the donor site.