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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00260494 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence |
Procedure: standardized acupuncture Procedure: Active Control: standardized sham acupuncture |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | April 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-operative
Post-operative
Contacts and Locations| 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, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143-0648 | |
| Principal Investigator: | Harriet W Hopf, MD | University of California, San Francisco |
More Information
| Study ID Numbers: | H7546-25444 |
| Study First Received: | November 29, 2005 |
| Last Updated: | March 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00260494 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cardiac Surgical Procedures open saphenous vein graft harvest wounds open saphenous vein graft harvest wounds |
Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence |
|
Surgical Wound Dehiscence Communicable Diseases Pathologic Processes Postoperative Complications Wounds and Injuries |
Disorders of Environmental Origin Surgical Wound Infection Infection Wound Infection |