Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Ulm, Germany.
Department of Otorhinolaryngology, University Hospital Augsburg, Sauerbruchstraße 6, 86153, Augsburg, Germany.
Eur Arch Otorhinolaryngol. 2024 Dec;281(12):6613-6620. doi: 10.1007/s00405-024-08869-6. Epub 2024 Aug 2.
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 (Vicryl, standard arm) with continuous self-locking, monofilament barbed suture (V-Loc, experimental arm).
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.
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).
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.
The trial was registered with WHO acknowledged primary registry "German Clinical Trials Register" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).
淋巴结切除术/颈清扫术是头颈部恶性肿瘤外科治疗的典型组成部分。本研究的目的是比较使用单结、编织缝线（Vicryl，标准组）与连续自锁、单丝带刺缝线（V-Loc，实验组）进行皮下闭合的效果。
颈锁（Neck Lock）是在一家单一的三级转诊中心进行的随机临床试验。它于 2016 年至 2022 年进行，随访期为 3 个月。安全性和美容效果评估为双盲。在应用排除标准后，对 68 例患者进行了随机分组。采用患者内随机方式进行皮下缝线技术的皮下伤口闭合。主要终点是皮下缝线的持续时间。次要终点为术后多个时间点记录伤口愈合和瘢痕形成情况。
中位年龄为 61 岁，89.7%为男性。92.6%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）的皮下缝线时间中位数存在显著差异（p=0.024）。评估不良事件（AE）时，两组之间的安全性无显著差异。带刺缝线和光滑缝线分别有 14.7%和 5.9%至少发生一次 AE（p=0.16）。
对于头颈部恶性肿瘤的颈清扫术，与单结技术相比，自锁缝线的皮下伤口闭合可显著节省时间，且安全性和美容效果相似。
该试验在世界卫生组织认可的主要登记处“德国临床试验注册中心”注册，编号为 DRKS00025831（https://drks.de/search/de/trial/DRKS00025831）。
