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Acupuncture and Post-Surgical Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260494
Recruitment Status : Terminated (No difference in primary outcomes at interim analysis.)
First Posted : December 1, 2005
Last Update Posted : July 23, 2013
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence Other: acupuncture Other: sham acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : March 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: acupuncture
acupuncture to lower extremity postoperatively
Other: acupuncture
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

Primary Outcome Measures :
  1. Transcutaneous tissue oxygen tension [ Time Frame: postoperative days 0, 1, 2, 3 ]

Secondary Outcome Measures :
  1. ASEPSIS score [ Time Frame: postoperatively ]
  2. Transcutaneous tissue microperfusion [ Time Frame: postoperative day 0, 1, 2, 3 ]
  3. Pain visual analogue scale (VAS) [ Time Frame: postoperative days 0, 1, 2, 3 ]
  4. 24-hour narcotic usage [ Time Frame: postoperative days 0, 1, 2, 3 ]
  5. Anxiety VAS [ Time Frame: postoperative days 0, 1, 2, 3 ]
  6. State-Trait Anxiety Inventory (STAI) [ Time Frame: preoperative and postoperative ]
  7. Serum epinephrine [ Time Frame: postoperative ]
  8. Serum cortisol [ Time Frame: postoperative ]
  9. Traditional Chinese Medicine pulse and tongue assessment [ Time Frame: postoperative ]
  10. Patient belief and expectancy survey [ Time Frame: preoperative ]

Other Outcome Measures:
  1. complications of acupuncture [ Time Frame: duration of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:


  • Emergent CABG, valves
  • History of peripheral vascular surgery, amputation, severe peripheral neuropathy, immunocompromise, or end-stage renal disease requiring hemodialysis


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00260494

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Harriet W Hopf, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT00260494    
Other Study ID Numbers: H7546-25444
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Keywords provided by University of California, San Francisco:
Cardiac Surgical Procedures
open saphenous vein graft harvest wounds
Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Postoperative Complications
Surgical Wound Dehiscence
Wounds and Injuries
Surgical Wound
Pathologic Processes