Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Transcutaneous tissue oxygen tension
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
acupuncture
acupuncture to lower extremity postoperatively
Intervention: acupuncture (Other)
sham acupuncture
sham acupuncture at same sites.
Intervention: sham acupuncture (Other)
control
no acupuncture, otherwise the same care and measurements
Outcomes
Primary Outcomes
Transcutaneous tissue oxygen tension
Time Frame: postoperative days 0, 1, 2, 3
Secondary Outcomes
- 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)