生物型无菌护创膜与透明敷料在供皮区创面愈合中的疗效比较  

Comparison of Curative Effect Between Biological Sterile Wound Protective Membrane and Transparent Dressing in Wound Healing of Skin Supply Area

作　　者：张波[1] 达吾力·沙里木江 赵阳[1] 于扬[1] 阿克巴尔·阿合买提[1] ZHANG Bo;Dawuli·SHALIMUJIANG;ZHAO Yang;YU Yang;Akebaer·AHEMAITI(Department of Burn,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,Xinjiang,China)

机构地区：[1]新疆医科大学第一附属医院烧伤科,新疆乌鲁木齐830054

出　　处：《中国美容医学》2021年第2期66-68,共3页Chinese Journal of Aesthetic Medicine

摘　　要：目的:通过临床试验验证生物型无菌护创膜在供皮区创面愈合中的安全性、有效性,为以后可能使用该产品用于同类创面提供临床依据。方法:笔者医院承担本次多中心临床试验的试验组和对照组病例各6例,合计12例,2017年6月-2018年1月,采用随机、阳性平行对照、单盲临床试验原则,将生物无菌护创膜(试验组)或透明敷料(对照组)分别用于入组病例供皮区创面,并对试验组在创面愈合过程中的安全性、有效性做出评价。结果:本次试验共入组了12例患者,顺利完成了临床试验。两组创面愈合时间、疼痛评分、创面感染、炎症反应情况及不良事件发生率比较差异均无统计学意义(P>0.05)。结论:生物无菌护创膜与透明敷料相比,两者安全性、有效性相当,其可作为创面敷料的较为理想选择。Objective To verify the safety and efficacy of the biological sterile wound protective membrane in wound healing of the skin supply area by clinical trials,and to provide a clinical basis for the possible use of this product for similar wounds in the future.Methods Our hospital is responsible for the trial group and the control group of this multi-center clinical trial each 6 cases,a total of 12 cases.From June 2017 to January 2018,using the principles of random,positive parallel control,single blind clinical trial,biological sterile wound protective membrane(the trial group)or transparent dressing(the control group)were used for the wound in skin supply area of the patients enrolled in the group.The safety and effectiveness of the trial group in the process of wound healing were evaluated.Results A total of 12 patients were enrolled in this trial,and the clinical trial was successfully completed.There were no significant differences in wound healing time,pain score,wound infection,inflammatory reaction and incidence of adverse events between the two groups(P>0.05).Conclusion Compared with transparent dressing,the biological sterile wound protective membrane has the same safety and effectiveness,which can be used as an ideal choice for wound dressing.

关 键 词：临床试验 创面愈合 生物型无菌护创膜 透明敷料 不良事件 安全性 

分 类 号：R622[医药卫生—整形外科]