A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants who develop ventral incisional hernia
研究概览
简要总结
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
详细描述
Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will be blinded after the assignment.
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
- •Participant is a male or female 18 years of age or older.
- •Participant is a current patient at West Michigan Cancer Center.
- •Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
- •Participant is willing and able to provide written informed consent before surgery.
排除标准
- •Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
- •Participant has history of previous VIH.
- •Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
结局指标
主要结局
Number of participants who develop ventral incisional hernia
时间窗: From enrollment to end of study participation at 12 months
Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications
次要结局
- Change in quality of life("Day 1," "Month 1," "Month 3," "Month 6," "Month 12")
- Post operative pain(From enrollment to end of study participation at 12 months)
- Safety of stratafix sutures compared to standard of care wound closure(From enrollment to end of study participation at 12 months)
研究者
Gitonga Munene
Principal Investigator
West Michigan Cancer Center