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| 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. |
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| 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:
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 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 |
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| Condition † | Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence |
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| Intervention † | Procedure: standardized acupuncture Procedure: Active Control: standardized sham acupuncture |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 120 | ||||||||
| Start Date † | March 2005 | ||||||||
| Completion Date | April 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: Pre-operative
Post-operative
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00260494 | ||||||||
| Organization ID | H7546-25444 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of California, San Francisco | ||||||||
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| Investigators † |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | September 2006 | ||||||||
| First Received Date † | November 29, 2005 | ||||||||
| Last Updated Date | March 20, 2007 | ||||||||
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