Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 654
- 试验地点
- 1
- 主要终点
- Composite incidence of superficial and deep surgical site infections
研究概览
简要总结
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.
详细描述
Background:
Surgical site infections (SSI) are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality, longer hospital stay, and significantly increased healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) is a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery. However, based on the available randomized controlled trials (RCT), the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient.
Rationale:
Considering the frequent occurrence of SSI in abdominal surgery, associated worse outcomes, and insufficient evidence, an adequately powered, robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted. Provided that ciNPWT significantly reduces the incidence of SSI, this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery.
Aim of the trial:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations
- •Incision length ≥ 10 cm
- •Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)
- •Abdominal closure with or without mesh implantation
- •Primary abdominal closure or closure after open abdomen treatment
- •Age over 18 years
- •Written informed consent
排除标准
- •Age ≤ 18 years
- •CDC wound class 4 (dirty/infected wound)
- •Organ transplantation
- •Sensitivity or allergy to silver
研究组 & 干预措施
Closed incision negative pressure wound therapy
At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days.
干预措施: Closed incision negative pressure wound therapy (Device)
Standard dressing
At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers.
干预措施: Standard dressing (Device)
结局指标
主要结局
Composite incidence of superficial and deep surgical site infections
时间窗: 30 (+/- 7) days
Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.
次要结局
- Number of outpatient visits(30 days)
- Postoperative health-related quality of life (SF-36 Health Survey)(30 (+/- 7) days)
- Duration of closed incision negative pressure wound therapy(7 days)
- Overall surgical site infections (superficial, deep, and organ space)(30 (+/- 7) days)
- Postoperative hospital length of stay(Usually between 1 and 14 days)
- Superficial, deep, and organ space surgical site infections as separate outcomes(30 (+/- 7) days)
- Other wound complications (wound dehiscence, seroma, hematoma)(30 (+/- 7) days)
- Costs for inpatient treatment(Usually between 1 and 14 days)
- In-hospital mortality(Usually between 1 and 14 days)
- 30-day mortality(30 days)