A Comparison of the Outcomes in Fortiva and Strattice Mesh
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Frequency of Participants With a Hernia Recurrence
研究概览
简要总结
A comparison of ventral hernia repair with Strattice and Fortiva mesh.Primary The study team aims to determine the hernia recurrence rates for RTI Surgical biologic mesh (Fortiva) compared to Strattice. Also the study team aims to determine the mesh related complications for RTI Surgical biologic mesh (Fortiva) compared to Strattice
详细描述
This study will be a prospective, matched study of patients using Fortiva biologic mesh to determine the rates of hernia recurrence and mesh related complication compared to Strattice mesh. Patients who meet the inclusion and exclusion criteria will be prospectively enrolled to receive a Ventral Hernia Repair (VHR) using Fortiva biologic mesh and will be compared to a retrospective cohort of patients with a VHR that utilized Strattice mesh. Patients will be propensity matched in a 1:3 (Fortiva : Strattice) fashion based on age, sex, and hernia defect size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ventral Hernia requiring surgical repair
排除标准
- •Pregnant women
结局指标
主要结局
Frequency of Participants With a Hernia Recurrence
时间窗: 1 year follow up post surgical repair
Frequency of participants with a hernia recurrence
Percentage of Participants With a Hernia Recurrence
时间窗: 1 year follow up post surgical repair
Percentage of participants with a hernia recurrence
次要结局
- Number of Participants With a Mesh Related Complication(1 year follow up post surgical repair)
- Percent of Participants With a Mesh Related Complication(1 year follow up post surgical repair)