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Acupuncture and Post-Surgical Wound Healing

This study is currently recruiting participants.
Information provided by University of California, San Francisco

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Descriptive Information Fields
Brief Title  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
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, 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.

Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Transcutaneous tissue oxygen tension
Secondary Outcome Measure  ASEPSIS score
Subcutaneous tissue oxygen tension
Transcutaneous tissue microperfusion
Pain visual analogue scale (VAS)
24-hour narcotic usage
Anxiety VAS
State-Trait Anxiety Inventory (STAI)
Serum epinephrine
Serum cortisol
Traditional Chinese Medicine pulse and tongue assessment
Patient belief and expectancy survey
Condition  Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence
Intervention  Procedure: standardized acupuncture
Procedure: Active Control: standardized sham acupuncture
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  120
Start Date  March 2005
Completion Date April 2007
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Harriet W Hopf, MD     (801) 205-1013     harriet.hopf@hsc.utah.edu    
Contact: Jodi D Sherman, MD     (415) 203-6500     shermanj@stanford.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00260494
Organization ID H7546-25444
Secondary IDs ††
Study Sponsor  University of California, San Francisco
Collaborators ††
Investigators 
Principal Investigator:     Harriet W Hopf, MD     University of California, San Francisco    
Information Provided By University of California, San Francisco
Verification Date September 2006
First Received Date  November 29, 2005
Last Updated Date March 20, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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