ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 12
- 主要终点
- Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
研究概览
简要总结
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
详细描述
This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.
The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects who meet all of the following criteria will be eligible for study enrollment:
- •Subjects who are 18 years of age and older
- •Subjects of either sex
- •Subjects who require complex abdominal repair using Permacol™ Biological Implant.
- •Subjects who are willing and able to adhere to protocol requirements and provide written informed consent
排除标准
- •All subjects who meet any of the following criteria should not be enrolled into the study:
- •Subjects who are pregnant
- •Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
- •Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
- •Concomitant use of a synthetic or another biologic mesh
- •Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
- •Subject who has systemic sepsis at the time of Permacol™ implantation
- •Subject with ongoing necrotizing pancreatitis
- •Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair
- •Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
- •Permacol™ used in pelvic floor reconstruction
结局指标
主要结局
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
时间窗: 36 months post-surgery
Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
次要结局
- Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome(6, 12, 24 and 36 months post-surgery)
- QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.(6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.)
- Patient Satisfaction Questionnaire - Right Choice to Have Surgery(6, 12, 24 and 36 months post-surgery)
- Number of Participants With Post-op Complications(6, 12, 24 and 36 months post-surgery)
- Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence(24 months post-surgery)