Acupuncture and Post-Surgical Wound Healing
|Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence||Other: acupuncture Other: sham acupuncture|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
- ASEPSIS score [ Time Frame: postoperatively ]
- Transcutaneous tissue microperfusion [ Time Frame: postoperative day 0, 1, 2, 3 ]
- Pain visual analogue scale (VAS) [ Time Frame: postoperative days 0, 1, 2, 3 ]
- 24-hour narcotic usage [ Time Frame: postoperative days 0, 1, 2, 3 ]
- Anxiety VAS [ Time Frame: postoperative days 0, 1, 2, 3 ]
- State-Trait Anxiety Inventory (STAI) [ Time Frame: preoperative and postoperative ]
- Serum epinephrine [ Time Frame: postoperative ]
- Serum cortisol [ Time Frame: postoperative ]
- Traditional Chinese Medicine pulse and tongue assessment [ Time Frame: postoperative ]
- Patient belief and expectancy survey [ Time Frame: preoperative ]
- complications of acupuncture [ Time Frame: duration of study ]
|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|