Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 6
- 主要终点
- Wound complications
研究概览
简要总结
The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is:
Does NPWT decrease wound complications?
Researchers will compare it against regular dressings to see if NPWT is superior.
详细描述
Negative Pressure Wound Therapy (NPWT) is a method of treating wounds using suction. The dressing is airtight, and the pump creates subatmospheric pressure, clearing the wound of exudate and fluids.
The study aims to investigate the effect of Negative pressure wound therapy dressings on the rate of wound complications (SSI, WD, seroma) after emergency laparotomy. Patients will be randomised to regular dressings and investigational device 1:1. No other aspect of the care will be changed.
Randomisation is planned at the time of skin closure. Patients will be followed-up after 14, 30 and 365 days with two initial visits, surveys and offered a CT scan to investigate incisional hernia formation.
The hypothesis is that NPWT dressings decrease the rate of wound complications. The secondary outcome is reduction of SSI, WD, seroma, shorter length of stay, peri-wound blistering, patient satisfaction.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessments and analyses will be masked. It's not feasible to blind Participants and Care Providers
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Written informed consent
- •>10 cm midline incision with primary skin closure
- •Emergency laparotomy
排除标准
- •Not able to consent (e.g. dementia, impaired cognitive function, unconscious)
- •Subjects not possible to follow up as assessed by the Investigator
- •Allergy to dressing material
- •Pregnancy or breastfeeding (females of childbearing potential)
- •Previous enrolment in the current study
- •Expected reoperation with 28 days of index laparotomy
- •Emergency laparotomy within 3 months
研究组 & 干预措施
Investigational device
Will recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision
干预措施: Negative pressure wound therapy (Device)
Standard of care
Will recieve a regular dressing after closure of emergency surgery incision
干预措施: Standard postoperative dressing (Device)
结局指标
主要结局
Wound complications
时间窗: 14 and 30 days
Incident rate of wound complications (infection, dehiscence, seroma)
次要结局
- Surgical site infections(14 and 30 days)
- Wound dehiscence(14 and 30 days)
- Mortality(14, 30 days and 1 year)
- Incidence rate of seromas(14 and 30 days)
- Incidence of hematomas(14 and 30 days)
- Incidence of ischemia around and in wound(14 and 30 days)
- Incidence of enterocutaneus fistula(14 and 30 days)
- Need for antibiotics after surgery(14 and 30 days)
- Incidence of other infections after surgery(14 and 30 days)
- Number of healthcare visits after surgery(14 and 30 days)
- Reoperation rate(14 and 30 days)
- Length of stay(30 days)
- Quality of life survey(30 days and 1 year)
- Scar satisfaction(30 days and 1 year)
- Incidence of incisional hernias(1 year)
- Costs(30 days)
- Incidence of hernias(5 years)
- Incidence of small bowel obstruction(5 years)
- Incidence of reconstructive surgery(5 years)