Clinical trial NCT00260494: Acupuncture and Post-Surgical Wound Healing
Official title: Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence
Keywords: Cardiac Surgical Procedures
open saphenous vein graft harvest wounds
Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-12-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Transcutaneous tissue oxygen tension
timeFrame: postoperative days 0, 1, 2, 3
Secondary outcomes:
measure: ASEPSIS score
timeFrame: postoperatively
measure: Transcutaneous tissue microperfusion
timeFrame: postoperative day 0, 1, 2, 3
measure: Pain visual analogue scale (VAS)
timeFrame: postoperative days 0, 1, 2, 3
measure: 24-hour narcotic usage
timeFrame: postoperative days 0, 1, 2, 3
measure: Anxiety VAS
timeFrame: postoperative days 0, 1, 2, 3
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: preoperative and postoperative
measure: Serum epinephrine
timeFrame: postoperative
measure: Serum cortisol
timeFrame: postoperative
measure: Traditional Chinese Medicine pulse and tongue assessment
timeFrame: postoperative
measure: Patient belief and expectancy survey
timeFrame: preoperative
Other outcomes:
measure: complications of acupuncture
timeFrame: duration of study
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Harriet W Hopf, MD
role: PRINCIPAL_INVESTIGATOR
References: