Abstract：
OBJECTIVE: 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).
CONCLUSIONS: 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.
UNASSIGNED: The trial was registered with WHO acknowledged primary registry \"German Clinical Trials Register\" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).
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).
CONCLUSIONS: 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.
UNASSIGNED: The trial was registered with WHO acknowledged primary registry \"German Clinical Trials Register\" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).
摘要：
目的：淋巴结切除/颈清扫是头颈部恶性肿瘤外科治疗的典型部分。这项研究的目的是比较使用单打结的皮下闭合，编织缝合线(VicrylTM,标准臂)具有连续自锁，单丝倒刺缝合线（V-LocTM，实验臂)。
方法：颈部锁定是在一个三级转诊中心进行的一项随机临床试验。从2016年到2022年进行，随访期为3个月。安全性和美学结果的评估是双盲的。68例患者在应用排除标准后随机分组。皮下伤口闭合以内部随机方式进行缝合技术。主要终点是皮下缝合的持续时间。在多个术后间隔记录伤口愈合和瘢痕形成作为次要终点。
结果：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）之间的中位皮下缝合时间（p=0.024）存在显着差异。在评估不良事件（AE）时，安全性没有显着差异。至少有一个AE发生在14.7％与5.9%，分别用于倒钩和光滑缝线（p=0.16）。
结论：对于头颈部恶性肿瘤的颈部解剖，与单结技术相比，使用自锁缝线的皮下伤口闭合可节省大量时间，并具有类似的安全性和美学效果。
该试验已在WHO认可的主要注册处“德国临床试验注册”注册，ID为DRKS00025831（https://drks。去/搜索/去/试用/DRKS00025831)。
方法：颈部锁定是在一个三级转诊中心进行的一项随机临床试验。从2016年到2022年进行，随访期为3个月。安全性和美学结果的评估是双盲的。68例患者在应用排除标准后随机分组。皮下伤口闭合以内部随机方式进行缝合技术。主要终点是皮下缝合的持续时间。在多个术后间隔记录伤口愈合和瘢痕形成作为次要终点。
结果：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）之间的中位皮下缝合时间（p=0.024）存在显着差异。在评估不良事件（AE）时，安全性没有显着差异。至少有一个AE发生在14.7％与5.9%，分别用于倒钩和光滑缝线（p=0.16）。
结论：对于头颈部恶性肿瘤的颈部解剖，与单结技术相比，使用自锁缝线的皮下伤口闭合可节省大量时间，并具有类似的安全性和美学效果。
该试验已在WHO认可的主要注册处“德国临床试验注册”注册，ID为DRKS00025831（https://drks。去/搜索/去/试用/DRKS00025831)。
