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临床试验/NCT03940560
NCT03940560撤回不适用

Mesh Suture for Internal Load Bearing Closures

Wigmore Clinic2 个研究点 分布在 1 个国家开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Surgery healing complication, acute

研究概览

简要总结

Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs

详细描述

Sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. When tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. The hernia rate after primary laparotomy depends on the patient population, but is over 10%. In some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. In primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. Mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs.

A novel mesh suture, designed at Northwestern University (Chicago, IL) by Dr. Gregory Dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. Dr. Dumanian has employed the concept of using a mesh-like suture already in his clinical practice. He has cut strips from an FDA-approved piece of hernia mesh, and used them as sutures, tying them with knots.

Based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, Dr. Dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. These are internal permanent sutures and will not be removed. They are made of the identical material (polypropylene) used in standard sutures.

Mesh Sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. Tissue ingrowth around the filaments and into the suture improves their hold.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Deep orthopedic soft tissue approximation

排除标准

  • Pregnancy
  • Age less than 1 year old
  • Repair of skin or other epithelial surfaces
  • Poor subcutaneous tissues
  • Ongoing infection

结局指标

主要结局

Surgery healing complication, acute

时间窗: 30 days

Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure

次要结局

  • Surgery healing complication, delayed(Within 12 months)

研究者

发起方
Wigmore Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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