A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Frequency of Wound dehiscence
研究概览
简要总结
A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.
详细描述
The objective of the study is to evaluate the efficacy of the Prevena Plus 125 therapy Unit (KCI USA, Inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. Furthermore, the investigators want to illustrate which patients benefit most significantly from Prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with Prevena intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing spinal fusion surgery
- •Over 18 years old
排除标准
- •Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
- •Subjects who are pregnant at the date of surgery (SOC for surgery)
结局指标
主要结局
Frequency of Wound dehiscence
时间窗: 1-6 weeks following surgery
Determine if wound reopening (dehiscence) is present at surgical site or not.
Frequency of Seroma
时间窗: 1-6 weeks following surgery
Determine if seromas (collection of fluid under the skin) are present at surgical site or not.
Frequency of Surgical site infections
时间窗: 1-6 weeks following surgery
Determine if infection is present at surgical site or not.
次要结局
- Frequency of skin necrosis(1-6 weeks following surgery)
- Frequency of skin necrosis(1-6 weeks following surgery)
- Frequency of readmission(1-6 weeks following surgery)
研究者
Robert Galiano
Associate Professor of Surgery
Northwestern University