The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tissue Oxygen Tension in the Sternal Wound
研究概览
简要总结
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
详细描述
Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization.
The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections.
Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
排除标准
- •Emergency surgery
- •Pre - or postoperative on intraaortic balloon pump
- •Preoperative mechanical ventilation
- •Postoperative respiratory failure
- •Postoperative extracorporal membrane oxygenation
- •Left ventricular function < 40%
- •Fever (core temperature > 38 °C) or current infection
- •No anticipated or no definitive primary closure of surgical wound.
结局指标
主要结局
Tissue Oxygen Tension in the Sternal Wound
时间窗: 8 hours
Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.
次要结局
未报告次要终点
研究者
Helmut Hager
MD
Medical University of Vienna