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Acupuncture and Post-Surgical Wound Healing
This study is currently recruiting participants.
Study NCT00260494   Information provided by University of California, San Francisco
First Received: November 29, 2005   Last Updated: March 20, 2007   History of Changes

November 29, 2005
March 20, 2007
March 2005
 
Transcutaneous tissue oxygen tension
Same as current
Complete list of historical versions of study NCT00260494 on ClinicalTrials.gov Archive Site
  • 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
  • ASEPSIS Score
  • Subcutaneous Tissue Oxygen Tension
  • Transcutaneous Tissue Mircroperfusion
  • Pain VAS
  • 24-hour narcotic usage
  • Anxiety VAS
  • STAI
  • serum epinephrine
  • serum cortisol
  • Traditional Chinese Medicine pulse and tongue assessment
  • Patient belief and expectancy survey
 
Acupuncture and Post-Surgical Wound Healing
Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest

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.

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.

Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Postoperative Complications
  • Surgical Wound Infection
  • Surgical Wound Dehiscence
  • Procedure: standardized acupuncture
  • Procedure: Active Control: standardized sham acupuncture
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
April 2007
 

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
Both
18 Years and older
No
Contact: Harriet W Hopf, MD (801) 205-1013 harriet.hopf@hsc.utah.edu
Contact: Jodi D Sherman, MD (415) 203-6500 shermanj@stanford.edu
United States
 
NCT00260494
 
H7546-25444
University of California, San Francisco
 
Principal Investigator: Harriet W Hopf, MD University of California, San Francisco
University of California, San Francisco
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP