一次性可吸收钉皮内吻合器在甲状腺和乳腺手术切口闭合中的前瞻性随机对照临床研究  

Disposably absorbable intradermal stapler in the closure of surgical incisions of thyroid and breast:A prospective randomized controlled clinical study

作　　者：白萍[1] 李云生[2] 葛智成[3] 方仪[4] 潘高峰 修典荣[6] 张忠涛[3] BAI Ping;LI Yun-sheng;GE Zhi-cheng(Operation Room,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;不详)

机构地区：[1]中国医学科学院肿瘤医院手术室,北京100021 [2]首都医科大学附属北京友谊医院手术室,北京100050 [3]首都医科大学附属北京友谊医院普外科,北京100050 [4]中国医学科学院肿瘤医院乳腺外科,北京100021 [5]北京颐合恒瑞医疗科技有限公司,北京102200 [6]北京大学第三医院普外科,北京100191

出　　处：《中国医学装备》2021年第10期41-44,共4页China Medical Equipment

基　　金：中关村国家自主创新示范区重大高精尖成果产业化项目(20190512-14)“一次性可吸收钉皮内吻合器成果转化项目”。

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甲状腺和乳腺手术切口闭合中的应用及愈合情况。方法:选取医院收治的152例行甲状腺和乳腺手术患者,使用中央随机系统随机化分为观察组和对照组,每组76例,观察组采用一次性可吸收钉皮内吻合器行甲状腺和乳腺手术切口闭合;对照组采用传统可吸收缝线行甲状腺和乳腺手术切口闭合。分析比较两组患者术后第8 d切口甲级愈合率,以及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和(或)缝合钉吸收等疗效情况,评价一次性可吸收钉皮内吻合器的临床安全有效性。结果:两组患者术中单位长度切口缝合时间观察组短于对照组,两组比较差异有统计学意义(t=9.735,P<0.001);两组患者术后1 d和3 d缝合部位疼痛程度视觉模拟量表(VAS)评分比较,差异无统计学意义(t=0.773,t=0.605;P>0.05);两组患者术后8 d切口甲级愈合率、术后8 d、(42±3)d以及28周(+10 d)缝合线和(或)缝合钉吸收情况进行比较,差异均无统计学意义。结论:一次性可吸收钉皮内吻合器与合成可吸收外科缝线相比具有缝合速度快、实现临床手术切口快速闭合、缩短手术时间和降低医疗成本的优势。Objective:To compare the application and healing of disposable absorbable intradermal stapler and polysorb in the closure of surgical incisions of thyroid and breast.Methods:152 patients who underwent the surgery of thyroid and breast were prospectively selected,and they were divided into observation group(76 cases)and control group(76 cases)according to the central random system.The observation group adopted disposable absorbable intradermal stapler to implement the closure of surgical incisions of thyroid and breast,and the control group adopted conventional polysorb to implement that.Grade A healing rates of incision at the 8th d post operation between two groups were analyzed and compared,as well as other curative effects included suture time of the incision per unit length,the effect of wound healing,the pain degree at the position of suture and the absorption of suture line and(or)suturing stapler.And then,the clinical safety and effectiveness of disposable absorbable intradermal stapler were further evaluated.Results:The intraoperative suture time of the incision per unit length of observation group was significantly shorter than that of control group(t=9.735,P<0.001).There was no significant difference in the scores of visual analog scale(VAS)of the pain at the position of suture in the 1st and the 3th day after surgery between the two groups(t=0.773,t=0.605,P>0.05).There were no statistically significant differences between the two groups in grade A healing rate of incision,the absorption situation at the 8th d,the(42±3)d and 28 weeks(+10 d)after surgery.Conclusion:Compared with polysorb,the disposable absorbable intradermal stapler has a series of advantages include fast suture speed,realizing fast closure of clinically surgical incision,shortening operation time and reducing medical cost.

关 键 词：一次性可吸收钉皮内吻合器 创新器械 可吸收 甲状腺和乳腺切口 皮内缝合 间断缝合 

分 类 号：R318.6[医药卫生—生物医学工程]