NCT02691962已完成不适用
A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias
C. R. Bard22 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 22
- 主要终点
- Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
研究概览
简要总结
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
详细描述
This is a post-market, on-label study to understand the performance of the graft in the US.
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
- 否
入选标准
- •Subject must be willing and able to give written informed consent.
- •Subject must be diagnosed with a ventral or incisional midline hernia.
- •Mesh must be placed in the retro-rectus or intraperitoneal plane.
- •Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.
排除标准
- •The use of surgical graft as a bridge repair.
- •The subject has more than 4 prior recurrences.
- •Subject has a contraindication for the placement of surgical graft.
- •Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
- •The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides).
- •Subject has intact permanent mesh adjacent to the current hernia to be repaired.
- •Subject has peritonitis at the time of surgery.
- •The subject is an active smoker within the last 2 weeks prior to surgery.
- •Clinically significant Chronic Obstructive Pulmonary Disease or heart failure, defined as marked limitation in ability or inability to perform activities of daily living.
- •Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study.
- •Chronic steroid use (>6 months) or immunosuppression drugs.
- •Subject's body mass index (BMI) >45 kg/m
- •Subject has cirrhosis, and/or ascites.
- •Subject has a defined collagen disorder.
- •Known to be infected with human immunodeficiency virus (HIV).
- •Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits Activities of Daily Living, is on hemodialysis or peritoneal dialysis.
- •Subject is American Society of Anesthesiology (ASA) Class 4 or
- •Subject has a life expectancy < 2 years at the time of enrollment.
- •Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study.
- •Subjects with known sensitivity to porcine products.
- •Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin).
- •Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
结局指标
主要结局
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
时间窗: Up to 45 days post implantation
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
次要结局
- Number of Participants With Reoperation Due to Index Hernia Repair(24 months post implantation procedure)
- Number of Participants With Wound Occurrences > 45 Days Post Implantation(Day 45 and up to 2 years post implantation)
- Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure(Within 6 months and 24 months of implantation procedure)
- General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.(Baseline, 1, 3, 6, 12, 18, and 24 months post implantation)
- Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure(Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure)
- Number of Participants Who Returned to Work Post Implantation Procedure(Up to 2 years following implantation procedure)
- Duration of Participants Stay in Hospital Following Implantation Procedure(From index procedure day to discharge from hospital day)
研究者
研究点 (22)
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