From the Departments of Ear, Nose, and Throat Surgery, Burn Plastic Surgery, Gynaecology and Obstetrics, Plastic Surgery, and Research and Innovation and the Methodology and Biostatistics Unit, Nantes University Hospital; the Clinical Research Department, District Hospital Center; EA 4275 Biostatistics, Pharmacoepidemiology and Human Sciences Research Unit, and SPHERE, UMR INSERM U1246, Faculty of Medicine, University of Nantes; and the French School of Public Health.
Plast Reconstr Surg. 2020 Dec;146(6):777e-789e. doi: 10.1097/PRS.0000000000007356.
Deep dermal suturing is critical for scar quality outcomes. The authors evaluated a new, fast medical device for dermal suturing, with the hypothesis of noninferiority with regard to clinical scar and cost-effectiveness.
A prospective, patient-blind, randomized, multicenter noninferiority study in 26 French hospitals was conducted. Patients were randomized 1:1 to suturing with conventional thread or a semiautomatic stapler. The Patient Scar Assessment Scale was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale and Patient Scar Assessment Scale score, scar aesthetic quality 18 months after surgery, and occupational exposure to blood during surgery.
Six hundred sixty-four patients were enrolled, 660 were randomized, and 649 constituted the full analysis (stapler arm, n = 324; needle arm, n = 325). Primary endpoint Patient Scar Assessment Scale score in the stapler arm was not inferior to that in the needle arm at 3 months or after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 minutes in the needle arm (p = not significant). The mean suturing time was significantly lower in the stapler arm (p < 0.001). There were seven occupational exposures to blood in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p = 0.41). The additional cost of using the device was &OV0556;51.57 for the complete-case population.
Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
深层真皮缝合对于疤痕质量结果至关重要。作者评估了一种新的、快速的真皮缝合医疗器械，假设其在临床疤痕和成本效益方面不劣于传统缝线。
在 26 家法国医院进行了一项前瞻性、患者盲法、随机、多中心非劣效性研究。患者按 1:1 随机分为常规缝线组或半自动缝合器组。主要终点为 3 个月时的患者疤痕评估量表评分。次要终点为两种缝合方法的成本效益、并发症发生率、缝合/手术时间、观察者疤痕评估量表和患者疤痕评估量表评分、术后 18 个月疤痕美学质量以及手术期间职业性血液暴露。
共纳入 664 例患者，660 例随机分组，649 例患者进行全分析（缝合器组，n = 324；缝线组，n = 325）。3 个月和 18 个月时，缝合器组的患者疤痕评估量表评分不劣于缝线组。缝合器组的平均手术时间为 180 分钟，缝线组为 179 分钟（p = 无显著差异）。缝合器组的平均缝合时间显著低于缝线组（p < 0.001）。缝线组有 7 例职业性血液暴露，缝合器组有 1 例。两组并发症发生率无显著差异（p = 0.41）。使用该器械的额外成本在全分析集人群中为 51.57 欧元。
使用半自动缝合器进行伤口愈合的结果并不逊于传统缝线，且职业性血液暴露更少。
临床问题/证据水平：治疗性，I 级。
