Randomized Controlled Trial: Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- SSI rate
研究概览
简要总结
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also represent a major organizational, medical and financial challenge for the treatment team. There is therefore still a great need for effective prevention of wound healing disorders. It goes without saying that wound management plays a major role in the development of wound healing disorders. Nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. One point of criticism is that most of the existing studies are financed by the manufacturer. Due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. After extensive literature research, we are of the opinion that the Aquacel Surgical Ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.The study is a randomized prospective clinical trial. It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee. The study should include 440 heart patients and last for 12 months. It will compare the Aquacel Surgical Ag bandage against our conventional methods. This study is being conducted independently of the industry. We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. If the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.
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
盲法说明
The patients were blinded until the time of the intervention (application of the bandage after surgery). Due to the nature of this study, it was not possible to conceal the treatment after the procedure, as patients could see their bandages and find out their allocation. Using methods to conceal the dressings (covering with neutral dressing) would have changed the nature of the dressings and affected the treatment. The study team could also see the bandages and was therefore not blinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery bypass surgery
- •Elective and primary surgery (no reoperations)
- •Complete median sternotomy
- •Age under 90 years
- •Weight in the range of 50-140kg
- •No known allergy to silver or other wound dressings
- •No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone
- •Capacity to consent
排除标准
- •Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
- •Patients own decision
- •Lack of harvesting of at least one internal thoracic artery
- •Peri- and post-operative ventilation for >48h
- •Re-thoracotomy for reasons other than SSI, e.g., bleeding
- •Mortality within the first 30 days
结局指标
主要结局
SSI rate
时间窗: 30 days
overall rate of incidence of any kind of SSI
次要结局
- dressing changes(7 days)
- severity of SSI(30 days)
- need for treatment(30 days)
研究者
Dr. med. Kathrin Dohle
Cardiac surgery specialist
University Medical Center Mainz