NCT02739191已完成不适用
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle
J.C. Goslings1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
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
- 1
- 主要终点
- Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.
研究概览
简要总结
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patients ≥18 and ≤ 80 years
- •Orthopedic (trauma) surgery to the foot and/or ankle
- •Incision >3 cm
排除标准
- •Open fractures
- •Antibiotic treatment at the time of the operation for a concomitant disease or infection
- •Insufficient comprehension of the Dutch language
- •Patients with immune-deficiencies
- •Inability to address negative pressure wound therapy device
- •Active infection
研究组 & 干预措施
Intervention
Experimental
Prophylactic negative pressure wound therapy
干预措施: PICO, Smith & Nephew (Device)
结局指标
主要结局
Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria.
时间窗: 30 days
The number of POWI's within 30 days of surgery will be recorded. These will be classified in superficial and deep POWI's using the criteria as proposed by the CDC.
次要结局
- EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months(6 months)
- The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months(6 months)
研究者
J.C. Goslings
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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