Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Surgical site infection
研究概览
简要总结
Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.
NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.
In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.
详细描述
The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.
Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.
Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).
A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.
Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.
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
- 否
入选标准
- •High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
- •Surgical wound type III or IV..
排除标准
- •Patients not giving informed consent.
- •Patients requiring open abdominal wound care.
- •Patients with abdominal wall malignancy,
- •Patients with peritoneal carcinomatosis,
- •Patients who are planned for second look laparotomy within 5 days,
- •Patients with less thank 3 month life expectancy.
- •Patients who are operated with existing wound infection
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)
次要结局
- Full thickness abdominal wall dehiscence, requiring re-operation(30 days)
研究者
Dr. Balázs Bánky PhD
Head of the Department of Surgery, St. Borbala Hospital
St. Borbala Hospital