组织工程活性皮肤用于皮肤慢性溃疡创面临床研究

目的探讨组织工程活性皮肤修复皮肤慢性溃疡创面临床应用的有效性及安全性。方法选取不同临床单位符合临床试验要求的皮肤溃疡患者，随机分为试验组和对照组，试验组应用组织工程活性皮肤覆盖创面，对照组应用常规凡士林纱布覆盖，所有患者采用常规包扎并固定。临床研究观察时间为6个月，观察指标为治疗期患者的创面变化、创面愈合时间和愈合后的创面愈合质量；同时对全身及重要脏器进行检测。采用SPSS统计软件对试验组和对照组平均愈合时间进行t检验，分析两组间差异有无统计学意义。结果应用组织工程活性皮肤可在创面存活，促进创缘皮肤组织的新生并替代组织工程活性皮肤。与对照组相比应用后创面明显缩小，试验组的平均愈合时间24，37d，明显少于对照组（64．05d），有统计学意义。结论应用组织工程活性皮肤修复慢性皮肤溃疡创面可促进创面早期修复、缩短病程并降低由此产生的并发症；为组织工程活性皮肤的临床应用提供了切实可行的方法。

Clinical study on tissue engineering skin in chronic skin ulcer wound

Objective To study the effectiveness and safety of clinical application approach of tissue engineering active skin(TE-skin)in repairing of chronic skin ulcer.Methods Thirty-eight patients with skin ulcer in different clinical center were selected and enrolled in this study.After surgical debridement,TE-skin was applied directly on the wound in experimental group(n = 19)and vaseline dressing was applied on the wound in control group(n = 19)respectively.All the patients were conventionally dressed and fixed.The effectiveness and safety of TE-skin were assessed during trial.Results The TE-skin could continuous persist in the wound and stimulate wound healing.The average healing time of wound in the experimental group were significantly shorter than that in the control group.There was statistical significant difference between the two groups.Conclusion The chronic ulcer wound could be repaired by tissue engineering skin in promoing the early healing,shortening the ill course and reducing its complications.It is practical and fessible for clinical application of tissue engineering skin.