Prospective Observation of Wound Healing With Prevena Incision Management System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Scarring
研究概览
简要总结
This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.
详细描述
The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •abdominal procedure with incision >20cm
- •must be >18 years of age
排除标准
- •<18 years of age
- •history of allergy or reaction to adhesives
- •pregnant or anticipated pregnancy within 6 months
研究组 & 干预措施
Prevena
Incision with prevena device overlying
干预措施: Prevena (Device)
Standard of Care dressing
Prevena device is not used
干预措施: Standard of Care Dressing (Procedure)
结局指标
主要结局
Scarring
时间窗: 0-6 months
Assess quality of scar: hypertrophy, hyperpigmentation, etc
次要结局
未报告次要终点
研究者
Gregory R. Evans
Professor
University of California, Irvine