The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Vienna、奥地利、1090
- Medical University Vienna
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：conventional bandage
conventional bandage on sternal wound after skin closure after cardiac surgery.
conventional gauze covered with elastic adhesive (Medipore™ Dress-it) The designated bandage will be positioned in the operating room by the surgeons after the skin will be closed.
The conventional elastic bandage consists of several layers of gauze covered with a special adhesive bandage
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有源比较器：warming bandage
The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound.
A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound.
The surface temperature of heating card is fixed at 38°C, and heat is usually provided for two hours at a time.
That is, the experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Tissue Oxygenation Levels
大体时间：2 years
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2 years
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Tissue Oxygen Tension in the Sternal Wound
大体时间：8 hours
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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.
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8 hours
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合作者和调查者
调查人员
- 首席研究员：Barbara Kabon, MD、Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
- 首席研究员：Helmut Hager, MD、Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 1.0
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心脏外科的临床试验
conventional bandage的临床试验
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Arteriocyte, Inc.Department of Health and Human Services未知