A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
研究概览
简要总结
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
详细描述
Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
- •Have signed an informed consent form (ICF).
排除标准
- •Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
- •June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.
结局指标
主要结局
Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
时间窗: 9 + Months
A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
次要结局
- Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.(9+ Months)
- Procedural Time for AlloMax Surgical Graft Placement.(0 Days)