Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Surgical Site Infection (SSI) reduction
研究概览
简要总结
Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.
详细描述
All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing.
In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score.
Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abdominal surgery
- •open surgery
- •contaminated or dirty surgery
排除标准
- •not abdominal surgery
- •mininvasive surgery
- •clean surgery
研究组 & 干预措施
Prevena arm
patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days
干预措施: incisional negative pressure wound therapy (Device)
Control arm
patients underwent to contaminated/dirty surgery who positioned conventional dressing
干预措施: conventional dressing (Device)
结局指标
主要结局
Surgical Site Infection (SSI) reduction
时间窗: 7 months
quantify SSI decrease after incisional negative pressure wound therapy
次要结局
- Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer(2 years)
研究者
Marco Scatizzi
Chief, general surgery department
Ospedale Misericordia e Dolce