Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 发起方
- Symatese
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of the type and frequency of complications related to NEVELIA®
研究概览
简要总结
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.
The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.
详细描述
The NEVAL protocol is a descriptive study conducted in order to confirm the clinical evidence of safety and performance of NEVELIA®, as described in the literature on equivalent products.
This dermal substitute consists of an inner biodegradable dermal substitute made of bovine collagen (collagen of type I), covered with an outer silicone membrane. Its porosity and the speed of degradation allow the act of recolonization by the fibroblasts and initiation of the vascularization process within 3 weeks. The application procedure requires removement of the silicone layer and wound covering with an ultra-thin epidermal graft, possibly meshed. This surgical procedure is well-known and permits an ultra-thin epidermal graft.
All the patients will be treated with NEVELIA®, prior to autologous skin grafting within 3 weeks after its application. Then, three follow-up visits will be planned: post operatively, at 6 and 12 months.
The objectives are:
- Primary objective: To assess the type and frequency of complications
- Secondary objectives:
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
- •Patients aged 18 or older
- •Patient geographically stable,
- •Patient requiring dermal reconstruction after third-degree burns, reconstructive surgery or trauma surgery;
- •Patient who signed the non-opposition form;
- •Patient able to be followed up to 12 months.
排除标准
- •Patient with clinical signs of wound infection;
- •Allergic patient or with known allergy to bovine collagen or silicone;
- •Patient with life-threatening conditions;
- •Patient receiving a treatment that may affect wound healing;
- •Patient with an autoimmune or immunosuppressive disease;
- •Patient with a suspected neurological disease as Creutzfeldt-Jakob disease;
- •Patient simultaneously participating in another study;
- •Pregnant or nursing woman.
结局指标
主要结局
Assessment of the type and frequency of complications related to NEVELIA®
时间窗: Up to 12 months
次要结局
- Take rate of NEVELIA®(At Day 21)
- Take rate of skin graft(At Day 28, 6 and 12 months)
- Satisfaction rate of physician and patient(At 6 and 12 months)
- Quality of healed skin(At 6 and 12 months)
- Re-operation rate(At 12 months)