一次性可吸收钉皮内吻合器在腹部手术切口闭合中的前瞻性随机对照临床研究  

A Prospective Randomized Controlled Clinical Study of Disposable Absorbable Intradermal Stapler in the Closure of Abdominal Surgical Incisions

作　　者：李欣[1] 宋京海[2] 王永清[1] 李智飞[1] 陈扬[1] 王少为[2] 修典荣[1] LI Xin;SONG Jinghai;WANG Yongqing;LI Zhifei;CHEN Yang;WANG Shaowei;XIU Dianrong(Department of General Surgery,Peking University Third Hospital,Beijing 100191,China;Department of General Surgery,Beijing Hospital,Beijing 100730,China)

机构地区：[1]北京大学第三医院普外科,北京100191 [2]北京医院普外科,北京100730

出　　处：《中国医疗设备》2021年第11期147-149,163,共4页China Medical Devices

摘　　要：目的比较一次性可吸收钉皮内吻合器与合成可吸收外科缝线在腹部手术切口闭合中的应用及愈合情况。方法选取2015年6月至2016年4月,北京大学第三医院及北京医院行腹部手术者共136例,随机分为观察组和对照组,各68例。以术后第8天切口甲级愈合率作为主要疗效指标,以单位长度切口缝合时间、切口愈合效果、缝合部位疼痛程度和缝合线/钉吸收情况等作为次要疗效指标,评价一次性可吸收钉皮内吻合器的临床安全有效性。结果对两组受试者单位长度切口缝合时间,及术后1天、3天、7天缝合部位疼痛程度VAS评分进行比较,差异有统计学意义(P<0.05);对两组受试者术后第8天切口甲级愈合率、术后第8天、(42±3)天、28周(+10天)缝合线/钉吸收情况进行比较,差异无统计学意义(P>0.05)。结论与合成可吸收外科缝线相比,一次性可吸收钉皮内吻合器缝合速度快,疼痛程度低,可实现临床手术切口快速闭合,缩短手术时间,降低医疗成本。Objective To compare the application and healing of disposable absorbable intradermal stapler and synthetic absorbable surgical suture in abdominal surgical incision closure.Methods From June 2015 to April 2016,a total of 136 patients with abdominal surgery at Peking University Third Hospital and Beijing Hospital were randomly divided into observation group and control group,68 cases in each group.The healing rate of incision grade A at the 8th day after operation was taken as the primary efficacy index.The unit length incision suture time,healing effect of the incision,pain degree at the suture site and suture/nail absorption were taken as the secondary efficacy index to evaluate the clinical safety and effectiveness of disposable absorbable intradermal stapler.Results The comparison of the unit length incision suture time,and the VAS scores of the suture site pain on the 1st,3rd,and 7th days after surgery were statistically significant(P<0.05).The comparison of the healing rate of incision grade A on the 8th day,and the suture/staples absorption of the two groups on the 8th days,(42±3)days,and 28 weeks(+10 days)after surgery,there was no significant difference between the two groups(P>0.05).Conclusion Compared with synthetic absorbable surgical suture,the disposable absorbable intradermal stapler has the advantages of fast suture speed,low pain degree,rapid closure of surgical incision,shorter operation time and lower medical cost.

关 键 词：创新器械 可吸收 皮内缝合 间断缝合 

分 类 号：R459.3[医药卫生—治疗学]