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杜拉梅什注册研究:使用网片缝线进行腹壁闭合的短期结果

Duramesh registry study: short-term outcomes using mesh suture for abdominal wall closure.

作者信息

Hackenberger Paige N, Mittal Mehul, Fronza Jeffrey, Shapiro Michael

机构信息

Department of Surgery, Northwestern Feinberg School of Medicine, Chicago, IL, United States.

出版信息

Front Surg. 2024 Jan 11;10:1321146. doi: 10.3389/fsurg.2023.1321146. eCollection 2023.

DOI:10.3389/fsurg.2023.1321146
PMID:38274351
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10809794/
Abstract

INTRODUCTION

Sutures are flexible linear elements that join tissue and maintain their hold with a surgeon-created knot. Tension at the suture/tissue interface can cut the very tissues that sutures are designed to hold, leading to dehiscence and incisional hernia formation. A new suture design (Duramesh, Mesh Suture Inc., Chicago, IL) was approved for marketing by the United States Food and Drug Administration in September 2022. The multiple filaments of the mesh suture are designed to diffuse tension at the suture/tissue interface thereby limiting pull-through. The macroporosity and hollow core of the mesh suture encourage fibrovascular incorporation for a durable repair. We created the first registry and clinical report of patients undergoing mesh suture implantation to assess its real-world effectiveness.

METHODS

A patient registry was created based on institutional implant logs from January to August 2023 at an integrated health-care system. Operative reports were reviewed by the study team to verify use of "Duramesh" by dictation. Retrospective chart review was conducted to evaluate patient and surgical characteristics, follow-up, and short-term outcomes of interest. Results were analyzed using descriptive statistics and Chi-squared analysis with Microsoft Excel and GraphPad Prism.

RESULTS

Three hundred seventy-nine separate implantations by 56 surgeons across 12 (sub) specialties at a university hospital and two community hospitals were performed. Mesh suture was used for treatment of the abdominal wall in 314 cases. Follow-up averaged 80.8 ± 52.4 days. The most common abdominal wall indications were ventral hernia repair ( = 97), fascial closure ( = 93), abdominal donor site closure from autologous breast reconstruction ( = 51), and umbilical hernia repair ( = 41). Mesh suture was used in all Centers for Disease Control (CDC) wound classifications, including 92 CDC class 2 or 3 abdominal operations. There were 19 surgical site infections (6.1%) and 37 surgical site events (11.8%).

CONCLUSIONS

Short-term registry data demonstrates the wide diversity of surgical disciplines and scenarios in which mesh suture has been used to date. The early adoption of mesh suture into practice highlights that consequences of suture pull-through influence operative decision making. As this is the first interim report of the Duramesh mesh suture registry, follow-up is too short for characterization of long-term durability of abdominal wall closures.

摘要

引言

缝线是一种灵活的线性元件,用于连接组织,并通过外科医生打的结来保持其固定效果。缝线与组织界面处的张力可能会切割缝线原本要固定的组织,导致伤口裂开和切口疝形成。一种新的缝线设计(Duramesh,Mesh Suture Inc.,芝加哥,伊利诺伊州)于2022年9月获得美国食品药品监督管理局批准上市。网状缝线的多根细丝旨在分散缝线与组织界面处的张力,从而限制缝线的牵拉。网状缝线的大孔隙率和中空结构有助于纤维血管长入,实现持久修复。我们创建了首个接受网状缝线植入患者的登记系统和临床报告,以评估其实际效果。

方法

基于一家综合医疗系统2023年1月至8月的机构植入记录创建了一个患者登记系统。研究团队查阅手术报告,通过听写来核实“Duramesh”的使用情况。进行回顾性病历审查,以评估患者和手术特征、随访情况以及感兴趣的短期结局。使用Microsoft Excel和GraphPad Prism软件进行描述性统计分析和卡方分析。

结果

在一家大学医院和两家社区医院,56名外科医生在12个(亚)专科进行了379例独立植入手术。网状缝线用于治疗腹壁的有314例。平均随访时间为80.8±52.4天。最常见的腹壁适应证为腹侧疝修补术(n = 97)、筋膜闭合(n = 93)、自体乳房重建后的腹部供区闭合(n = 51)和脐疝修补术(n = 41)。网状缝线用于所有疾病控制中心(CDC)伤口分类,包括92例CDC 2级或3级腹部手术。有19例手术部位感染(6.1%)和37例手术部位事件(11.8%)。

结论

短期登记数据表明,迄今为止网状缝线已应用于广泛多样的外科学科和手术场景。网状缝线在实践中的早期应用凸显了缝线牵拉的后果会影响手术决策。由于这是Duramesh网状缝线登记系统的首份中期报告,随访时间过短,无法描述腹壁闭合的长期耐久性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/54d17504f0e1/fsurg-10-1321146-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/d9988994d3b5/fsurg-10-1321146-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/a23da1f39030/fsurg-10-1321146-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/74c360bee129/fsurg-10-1321146-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/9fa457477fdf/fsurg-10-1321146-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/54d17504f0e1/fsurg-10-1321146-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/d9988994d3b5/fsurg-10-1321146-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/a23da1f39030/fsurg-10-1321146-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/74c360bee129/fsurg-10-1321146-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/9fa457477fdf/fsurg-10-1321146-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef0/10809794/54d17504f0e1/fsurg-10-1321146-g005.jpg

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