Johannes Doescher, Benjamin Emmanuel, Jens Greve, Patrick J Schuler, Fabian Sommer, Simon Laban, Johannes Veit, Thomas K Hoffmann
{"title":"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。","authors":"Johannes Doescher, Benjamin Emmanuel, Jens Greve, Patrick J Schuler, Fabian Sommer, Simon Laban, Johannes Veit, Thomas K Hoffmann","doi":"10.1007/s00405-024-08869-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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<sup>TM</sup>, standard arm) with continuous self-locking, monofilament barbed suture (V-Loc<sup>TM</sup>, experimental arm).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration information: </strong>The trial was registered with WHO acknowledged primary registry \"German Clinical Trials Register\" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":" ","pages":"6613-6620"},"PeriodicalIF":1.9000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11564391/pdf/","citationCount":"0","resultStr":"{\"title\":\"Barbed suture in neck dissection: a randomized clinical study on efficacy, safety and aesthetic outcome.\",\"authors\":\"Johannes Doescher, Benjamin Emmanuel, Jens Greve, Patrick J Schuler, Fabian Sommer, Simon Laban, Johannes Veit, Thomas K Hoffmann\",\"doi\":\"10.1007/s00405-024-08869-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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<sup>TM</sup>, standard arm) with continuous self-locking, monofilament barbed suture (V-Loc<sup>TM</sup>, experimental arm).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration information: </strong>The trial was registered with WHO acknowledged primary registry \\\"German Clinical Trials Register\\\" under the ID DRKS00025831 ( https://drks.de/search/de/trial/DRKS00025831 ).</p>\",\"PeriodicalId\":11952,\"journal\":{\"name\":\"European Archives of Oto-Rhino-Laryngology\",\"volume\":\" \",\"pages\":\"6613-6620\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11564391/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Archives of Oto-Rhino-Laryngology\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://doi.org/10.1007/s00405-024-08869-6\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"OTORHINOLARYNGOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Archives of Oto-Rhino-Laryngology","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1007/s00405-024-08869-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/2 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"OTORHINOLARYNGOLOGY","Score":null,"Total":0}
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 ).
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.