颈部解剖中的带刺缝合:关于疗效、安全性和美学效果的随机临床研究。

IF 1.9 3区 医学 Q2 OTORHINOLARYNGOLOGY European Archives of Oto-Rhino-Laryngology Pub Date : 2024-12-01 Epub Date: 2024-08-02 DOI:10.1007/s00405-024-08869-6
Johannes Doescher, Benjamin Emmanuel, Jens Greve, Patrick J Schuler, Fabian Sommer, Simon Laban, Johannes Veit, Thomas K Hoffmann
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引用次数: 0

摘要

目的:淋巴结切除/颈部清扫是头颈部恶性肿瘤手术治疗的典型部分。本研究旨在比较使用单结编织缝合线(VicrylTM,标准臂)和连续自锁单丝倒钩缝合线(V-LocTM,实验臂)进行皮下缝合的效果:颈锁术是在一家三级转诊中心进行的随机临床试验。试验从 2016 年开始,至 2022 年结束,随访期为 3 个月。安全性和美学效果的评估采用双盲法。68名患者在适用排除标准后被随机选中。皮下伤口闭合以患者内随机方式进行缝合技术。主要终点是皮下缝合的持续时间。伤口愈合和疤痕形成作为次要终点,在术后多个时间间隔进行记录:中位年龄为 61 岁,89.7% 为男性。92.6%的患者患有鳞状细胞癌。实验组(6:11 ± 2:30分钟)和标准组(7:01 ± 2.42分钟)的中位皮下缝合时间有明显差异(p = 0.024)。在评估不良事件(AEs)时,安全性无明显差异。有倒刺缝合线和平滑缝合线的不良反应发生率分别为14.7%和5.9%(P = 0.16):结论:对于头颈部恶性肿瘤的颈部解剖,使用自锁缝合线进行皮下伤口缝合比单结技术节省大量时间,而且安全性和美观效果相似:该试验已在世界卫生组织认可的主要注册机构 "德国临床试验注册机构 "注册,注册号为 DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 )。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Barbed suture in neck dissection: a randomized clinical study on efficacy, safety and aesthetic outcome.

Purpose: The resection of lymph nodes/neck dissection is a typical part of the surgical treatment of head and neck malignancies. The aim of this study was to compare subcutaneous closure using single knotted, braided suture (VicrylTM, standard arm) with continuous self-locking, monofilament barbed suture (V-LocTM, experimental arm).

Methods: Neck Lock was a randomized clinical trial at a single tertiary referral center. It was conducted from 2016 till 2022 with a follow-up period of 3 months. Assessment of safety and aesthetic outcome was double-blinded. 68 patients were randomized after application of exclusion criteria. Subcutaneous wound closure was performed in an intrapatient randomized fashion for suture technique. The primary endpoint was the duration of subcutaneous sutures. Wound healing and scar formation were recorded at multiple postoperative intervals as secondary endpoints.

Results: The median age was 61 years, 89.7% were male. 92.6% suffered from a squamous cell carcinoma. There was a significant difference in median subcutaneous suture time (p = 0.024) between the experimental (6:11 ± 2:30 min) and standard (7:01 ± 2.42 min) arms. There was no significant difference in safety when assessing adverse events (AEs). At least one AE occurred in 14.7% vs. 5.9%, for barbed and smooth sutures respectively (p = 0.16).

Conclusion: For neck dissection of head and neck malignancies, subcutaneous wound closure with self-locking sutures offers significant time savings over the single knot technique with similar safety and aesthetic results.

Trial registration information: The trial was registered with WHO acknowledged primary registry "German Clinical Trials Register" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).

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来源期刊
CiteScore
5.30
自引率
7.70%
发文量
537
审稿时长
2-4 weeks
期刊介绍: Official Journal of European Union of Medical Specialists – ORL Section and Board Official Journal of Confederation of European Oto-Rhino-Laryngology Head and Neck Surgery "European Archives of Oto-Rhino-Laryngology" publishes original clinical reports and clinically relevant experimental studies, as well as short communications presenting new results of special interest. With peer review by a respected international editorial board and prompt English-language publication, the journal provides rapid dissemination of information by authors from around the world. This particular feature makes it the journal of choice for readers who want to be informed about the continuing state of the art concerning basic sciences and the diagnosis and management of diseases of the head and neck on an international level. European Archives of Oto-Rhino-Laryngology was founded in 1864 as "Archiv für Ohrenheilkunde" by A. von Tröltsch, A. Politzer and H. Schwartze.
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