Prevention of Seroma Formation After Body Contouring Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of seroma formation
研究概览
简要总结
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study
排除标准
- •Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
研究组 & 干预措施
Suction drain
Conventional body contouring procedure, application of Redon suction drains, drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7
Passive drain
Conventional body contouring procedure, application of drains without suction (passive drainage), drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7
干预措施: Variable drain usage (Procedure)
No drain
Conventional body contouring procedure, no application of drains
干预措施: Variable drain usage (Procedure)
结局指标
主要结局
Rate of seroma formation
时间窗: Weekly follow-up until postoperative week 6.
As primary outcome this study measures the rate of seroma requiring evacuation via puncture aspiration (fluid retention \> 20 cc) in each group.
次要结局
未报告次要终点
研究者
Dr. Alexandra Anker
Principal Investigator
University of Regensburg