Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Transcutaneous tissue oxygen tension
研究概览
简要总结
The purpose of this study is to determine if acupuncture improves wound healing. Since we, the investigators at the University of California, San Francisco (UCSF), know that how much oxygen is delivered to tissue is the best predictor of how well a wound will heal, we are measuring changes in tissue oxygen of wounds before and after acupuncture treatments. We are focusing on the leg wounds of coronary artery bypass graft (CABG) patients who have their saphenous veins harvested in an open fashion since this is a fairly well controlled patient model.
详细描述
This is a prospective, randomized, controlled pilot study of the effects of acupuncture on surgical site complications in patients undergoing coronary artery bypass grafting. The past forty years of research in the UCSF Wound Healing Laboratory have solidified the following observations:
- without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and
- hypoxic conditions, unfortunately, are common in chronic and acute wounds, and often result from subcutaneous vasoconstriction.
Sympathetic nervous system (SNS) activators and other vasoconstrictors have been shown to produce wound hypoxia. Activation of the SNS by any means, including pain and anxiety, causes vasoconstriction and impairs oxygen delivery. Simple means that limit SNS activity have been shown to increase perfusion and oxygen tension, and thereby facilitate wound healing. Many preliminary studies have shown that acupuncture decreases SNS activation, pain, and anxiety. In addition, there is evidence that acupuncture enhances circulation of blood. We therefore hypothesize that acupuncture will facilitate wound healing. We aim to quantify changes in anxiety, pain, stress hormones, and perfusion and oxygenation induced by these interventions, as well as wound healing outcomes, including infection and other wound complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults (age > 18)
- •Males/females
- •All races
- •Elective/urgent CABG
- •Open saphenous vein graft harvest
- •University of California, San Francisco, and additional approved hospital sites
排除标准
- •Pre-operative
- •Emergent CABG, valves
- •History of peripheral vascular surgery, amputation, severe peripheral neuropathy, immunocompromise, or end-stage renal disease requiring hemodialysis
- •Post-operative
- •Postoperative day 1 (POD1) hemodynamic instability
- •≥ 4u packed red blood cells transfusion (PRBC)/8 hours, CT > 200cc/hour 3 hours, > 2 pressors
- •Prolonged intubation (> POD1)
- •Altered mental status
结局指标
主要结局
Transcutaneous tissue oxygen tension
时间窗: postoperative days 0, 1, 2, 3
次要结局
- ASEPSIS score(postoperatively)
- Transcutaneous tissue microperfusion(postoperative day 0, 1, 2, 3)
- Pain visual analogue scale (VAS)(postoperative days 0, 1, 2, 3)
- 24-hour narcotic usage(postoperative days 0, 1, 2, 3)
- Anxiety VAS(postoperative days 0, 1, 2, 3)
- State-Trait Anxiety Inventory (STAI)(preoperative and postoperative)
- Serum epinephrine(postoperative)
- Serum cortisol(postoperative)
- Traditional Chinese Medicine pulse and tongue assessment(postoperative)
- Patient belief and expectancy survey(preoperative)