Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of hypoperfused skin island
研究概览
简要总结
A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.
详细描述
Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.
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
- •All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.
排除标准
- •Infection of skin of planned flap.
研究组 & 干预措施
Control group
No preconditioning of the flap.
Preconditioned group
Preconditioning of the flap prior to surgery.
干预措施: Preconditioning (Procedure)
结局指标
主要结局
Percentage of hypoperfused skin island
时间窗: up to 7 days postoperatively
The percentage of hypoperfused skin island should be measured clinically after surgery
Skin oxygen saturation of distal flap
时间窗: 1 day postoperative
The skin oxygen saturation of distal flap is measured via laserdoppler
次要结局
- Wound complications(up to 12 weeks postoperatively)
- VEGF expression in skin and muscle of flap(once during surgery)
- Density of flap dermal vessels(once during surgery)
研究者
Mehran Dadras, MD
Chief resident, Department of Plastic Surgery
Ruhr University of Bochum