Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI).
研究概览
简要总结
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
详细描述
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.
Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.
Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient aged ≥18 years,
- •Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure,
- •Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- •Patient being informed of the porcine origin of the device in advance of the procedure.
排除标准
- •Patient with known hypersensitivity to porcine materials,
- •Patient who is pregnant,
- •Patient having refused to participate to the study,
- •Patient refusing to return for the follow-up visits.
结局指标
主要结局
Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI).
时间窗: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
次要结局
- Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.(During the surgical procedure)
- Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan(Throughout the study until end of the 24-month follow-up period)
- Rate of recurrence/incisional hernia requiring reoperation(Throughout the study until end of the 24-month follow-up period)
- Rate of abdominal wall laxity(Throughout the study until end of the 24-month follow-up period)