Impact of Negative Pressure Wound Therapy on Free Muscle Flaps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA
研究概览
简要总结
Aim of the study is to prove the utility and safety of the negative pressure wound therapy (NPWT) in the postoperative management of free flaps.
The quantitative assessment of the entirety of clinical main relevant parameters like edema formation, microcirculation, macrocirculation and wound healing should create a better and comprehensive understanding of the NPWT effects in this field.
详细描述
This study evaluates the impact of negative pressure wound therapy on free muscle flaps. Flaps were treated with NPWT or with a conventional dressing (control) for five days following tissue transfer. Edema formation is measured by a 3D scan (Artec SpiderTM) during the operation, five and fourteen days after surgery. The macrocirculation- and microcirculation parameters of the flaps are assessed using an implanted Doppler probe (Cook-Swartz®) as well as combined flowmetry and remission spectroscopy (O2C®). These measurements are conducted daily at the day of the operation as well as the first five days following the operation. Following dressing removal at the fifth postoperative day, skin graft take is assessed.
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
- 是
入选标准
- •Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
- •existing cognitive faculty
排除标准
- •non-compliance
- •non-consent
结局指标
主要结局
Change of Flap Edema in the early postoperative period measured by a 3D Scan - Artec SpiderTM, Artec Group, Palo Alto, California, USA
时间窗: Measurements were conducted at the day of the operation, five and fourteen days following surgery
次要结局
未报告次要终点
研究者
Ulf Dornseifer, MD
Dr.med.
Klinik Bogenhausen