Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Incidence of infection of the sternal surgical wound.
研究概览
简要总结
The objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".
详细描述
Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed.
Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy).
All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs.
Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.
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 (Investigator)
盲法说明
External evaluator: care provider
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
- •Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
- •Who signs Informed Consent after agreeing to participate in the microbiological study.
排除标准
- •Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
- •Patients with immunocompromised haematological diseases.
- •Patients who are allergic or present some hypersensitivity to the dressing or excipient.
- •Patients who are participating in another experimental study.
- •Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
结局指标
主要结局
Incidence of infection of the sternal surgical wound.
时间窗: 1-3 months
The state of the surgical wound will be assessed and recorded on the wound care data collection sheet. Note whether the wound looks good or not and whether there are any complications: exudate, appearance of the wound, necrosis of the wound edges, redness, maceration of the wound or wound dehiscence.
次要结局
未报告次要终点