RANDOMISED CONTROL STUDY TO ASSES THE ROLE OF NEGATIVE PRESSURE WOUND THERAPY (NPWT) IN THE MANAGEMENT OF WOUND IN SURGICAL PATIENT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Reduction in wound infection by 50%
研究概览
简要总结
Aim of the study is to assess the role of negative pressure therapy in the prevention of the complication of the laparotomy wound in the high risk patients group.
Primary outcome: Reduction in wound infection rate by 50%
Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound management Decrease cost of patient treatment
详细描述
Wound complications are common in general surgical patients after laparotomy. The rate of Surgical Site Infections after elective surgery ranges between 3-30%, depending of the study.
There are subgroups of patients with co-morbid conditions that put them at high risk of wound complications. These co-morbid conditions include increase BMI, known malignancy, diabetes mellitus, emergency surgery, malnutrition, smoking and diffuse atherosclerotic disease involving arteries. Management of these complicated wounds are a significant source of psychological trauma to patients and significantly increases hospital stay and cost.
Since its introduction, Negative Pressure Wound Therapy (NPWT) has been used mainly to deal with chronic wounds. Mechanism of action of NPWT includes protection of wound bed, splinting of soft tissues, reduction of oedema, increasing blood perfusion of wound and enhancing granulation tissue. Application of Negative Pressure Wound Therapy to prevent wound complications is a new concept, which has been successfully applied in acute wounds in orthopaedics, gynecological and cardiothoracic surgery patients.
There is limited data about the use of Negative Pressure Wound Therapy in high risk general surgical patients with acute wounds, but available studies suggest significant reduction in wound complication rate and hospital costs. There is a need for a randomised controlled study to assess the reduction of wound complication ratio.
Patient will be randomized to two groups:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One from below:
- •Malignancy
- •Malnutrition
- •Emergency surgery
- •Post radio chemotherapy
- •On steroids
- •Open colorectal resection
- •At least two from below:
- •Diffuse atherosclerotic disease involving arteries
排除标准
- •Low risk laparotomy wound (none of the above criteria)
- •Age < 18
结局指标
主要结局
Reduction in wound infection by 50%
时间窗: 1 year
次要结局
- Decrease antibiotics use in a wound infection management(1 year)
- Reduction of the length of hospital stay(1 year)
- To decrease the cost of patient treatment(1 year)
研究者
Sebastian Smolarek
M.D
St James Connolly Memorial Hospital