Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Cost Saving
研究概览
简要总结
The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The institutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vitro to have improved tension on the abdominal wall that may obviate the need for costly Wittmann patch placement.
详细描述
The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The instiutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vivotro to have improved fascia movement that may obviate the need for costly Wittmann patch placement.
Primary Objective: Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that with use of the ABTHERA ADVANCE will lead to reduced variable costs compared to ABTHERA Open Abdomen dressing with Wittmann patch Secondary Objective(s): Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that rate of abdominal closure, component separation, and mesh placement will appear similar with use of ABTHERA ADVANCE compared to ABTHERA Open Abdomen dressing with Wittmann patch
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients aged ≥ 22
- •Severe necrotizing pancreatitis with abdominal compartment syndrome or severe sepsis requiring decompressive laparotomy and/or pancreatic debridement
- •Patients that require open abdomen at the conclusion of their index operation
排除标准
- •Female patients who are pregnant or lactating
- •If in the opinion of the treating physician a patient should not participate in this study.
结局指标
主要结局
Cost Saving
时间窗: 3 months after the last participant has been enrolled.
Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.
次要结局
- Effectiveness(3 months after the last participant has been enrolled.)