Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Healing Time
研究概览
简要总结
This is multi-center prospective, longitudinal case series with comparison to historical controls.
详细描述
The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed Informed Consent
- •Patients requiring split-thickness skin grafting with non-infected wounds
- •Age of participants: 18 years and above at the time of informed consent
- •Gender: Male or Female
- •Subjects who will be locally available for the next 6 months.
排除标准
- •Infected chronic wound
- •Patients who are unable to adhere to scheduled study visits
- •Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow
- •Patients who have an active drug/alcohol dependence or abuse history
- •Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.
研究组 & 干预措施
Split Thickness Skin Graft Harvest
Retrospective review
干预措施: Split Thickness Skin Graft (Procedure)
Cellutome Epidermal Harvesting System
Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System
干预措施: Cellutome Epidermal Harvesting System (Device)
结局指标
主要结局
Healing Time
时间窗: 8 weeks
Healing time is defined as the required time for the graft site to become dry enough for removal of the dressing without further discharge from the wound AND 100% re-epithelialization has occurred
次要结局
- Scarring(8 weeks)
- Healing at Donor Site(8 weeks)
- Complications(8 weeks)