Kerecis Real-World Fish Skin Graft Registry - "ISACOD"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Kerecis Ltd.
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Target Wound Infection
研究概览
简要总结
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
详细描述
This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent
- •Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date
排除标准
- 未提供
结局指标
主要结局
Target Wound Infection
时间窗: 12 months
Proportion of patients who develop target wound infection
Fish Skin Graft Device Related failure
时间窗: 12 months
Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)
Fish Skin Graft Device related allergy
时间窗: 12 months
Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development)
次要结局
- Complete Wound Closure(12 months)
- Complete Wound Healing(12 months)