Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The Incidence of Postoperative Hernia Recurrence
研究概览
简要总结
The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.
详细描述
This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue.
The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects.
This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is an adult ≥ 18 years old of either gender
- •Will undergo a planned open abdominal incisional hernia repair
- •Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
- •Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
- •Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
- •Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
- •Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
- •Is willing and able to return for all scheduled and required study visits
- •Is willing and able to provide written informed consent for study participation
排除标准
- •Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
- •Is a clean or dirty case per Surgical Site Infection Risk Guidelines
- •Has conditions that would adversely affect subject safety as per product labeling
- •Will undergo a laparoscopic hernia repair
- •Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
- •Has conditions which preclude abdominal imaging at a standard imaging facility
- •Has an anticipated survival of < 24 months
- •Care plan is to perform a staged repair over 45 days
- •Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
- •Is ASA class 4 or 5
- •BMI over 45
- •Is pregnant
结局指标
主要结局
The Incidence of Postoperative Hernia Recurrence
时间窗: two years after surgery date
次要结局
- Length of Hospital Stay(Number of days up to 1 week)
- Compare the Short-term Clinical Outcomes of Postoperative Wound Events(two years after surgery date)
- Length of Resource Utilization(two years after surgery date)
- Antibiotic Usage and Days(two years after surgery date)
- Resumption of Activities of Daily Living(two years after surgery date)