Acupuncture and Post-Surgical Wound Healing
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.
Surgical Wound Infection
Surgical Wound Dehiscence
Other: sham acupuncture
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest|
- Transcutaneous tissue oxygen tension [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
- ASEPSIS score [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
- Transcutaneous tissue microperfusion [ Time Frame: postoperative day 0, 1, 2, 3 ] [ Designated as safety issue: No ]
- Pain visual analogue scale (VAS) [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
- 24-hour narcotic usage [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
- Anxiety VAS [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
- State-Trait Anxiety Inventory (STAI) [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]
- Serum epinephrine [ Time Frame: postoperative ] [ Designated as safety issue: No ]
- Serum cortisol [ Time Frame: postoperative ] [ Designated as safety issue: No ]
- Traditional Chinese Medicine pulse and tongue assessment [ Time Frame: postoperative ] [ Designated as safety issue: No ]
- Patient belief and expectancy survey [ Time Frame: preoperative ] [ Designated as safety issue: No ]
- complications of acupuncture [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
acupuncture to lower extremity postoperatively
standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
Sham Comparator: sham acupuncture
sham acupuncture at same sites.
Other: sham acupuncture
standardized sham acupuncture at same sites as acupuncture.
No Intervention: control
no acupuncture, otherwise the same care and measurements
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260494
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0648|
|Principal Investigator:||Harriet W Hopf, MD||University of California, San Francisco|