跳至主要内容
临床试验/NCT03533595
NCT03533595已完成不适用

Prospective Analysis of STRATAFIX Symmetric PDS Plus Suture for Fascial Closure in Spinal Surgery; Pilot Study

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Reduced operating times

研究概览

简要总结

STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure following spinal surgery. A pilot study will aide in the design of a larger randomized controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures versus traditional Vicryl sutures.

详细描述

Effective and secure suture is integral in spinal surgery, creating a strong barrier for tissue repair and a seal which prevents infection of the surgical site. The goal of any suture is to close the wound while minimizing risks of complications such as wound dehiscence and surgical site infection . A new type of suture, barbed suture, uses integrated barbs to secure the suture to the tissue without requiring knots for fixation. The result is a suture that evenly distributes tension along the length of the incision, while requiring less time to close . Additionally, STRATAFIX sutures offer a "Plus" antibacterial option for their knotless sutures, which further increases the safety and efficacy of this product.

Barbed suture technologies have been utilized in a variety of specialties, but neurosurgery remains unstudied in this respect. The primary aim of this study is to assess the time to closure using STRATAFIX technology. Decreased time to closure directly translates into decreased operating room time, and thus increased savings, especially for high-volume institutions. The secondary aim of this study is to determine the risk for surgical complications using STRATAFIX. Previous studies in other specialties have shown no significant difference in rate of adverse consequences when utilizing barbed sutures. To assess this aim, patients will be evaluated for wound dehiscence, SSI, deep infection, and 30-day rate of readmission for wound infection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 to 75 years old
  • •Patients undergoing thoracolumbar fusion of at least 3 vertebral levels.
  • •Patient able to sign informed consent.

排除标准

  • •Current infection (osteomyelitis), diabetes, severely malnourished or other co-morbidities that the investigator believes does not make the patient a good candidate for surgery.
  • •Patients with incidental durotomy

研究组 & 干预措施

Stratafix Barbed Suture

Active Comparator

Stratafix Barbed Suture for thoracolumbar fusion will be used.

干预措施: Barbed (Device)

Standard Suture

No Intervention

Standard suture for thoracolumbar fusion will be used per standard of care.

结局指标

主要结局

Reduced operating times

时间窗: Patient followed for 6 months from surgery

STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure following spinal surgery. A pilot study will aide in the design of a larger randomized controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures versus traditional Vicryl sutures.

次要结局

  • Safety evaluation of wound dehiscence(Patient followed for 6 months from surgery)
  • Safety evaluation of 30 days readmission rates(Patient followed for 30 days from surgery)
  • Safety evaluation of surgical site infection (SSI) rate(Patient followed for 6 months from surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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