Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Amount of drainage fluid
研究概览
简要总结
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.
详细描述
Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
排除标准
- •No primary skin closure.
- •Skin infection in area of operation (e.g. acne inversa).
结局指标
主要结局
Amount of drainage fluid
时间窗: up to 14 days postoperatively
Measurement of total fluid amounts in drains and negative pressure device
次要结局
- Wound complications(3 months)
- Wound margin perfusion(5 days postoperatively)
研究者
Mehran Dadras, MD
Consultant, Department of Plastic Surgery
Ruhr University of Bochum