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No difference in primary outcomes at interim analysis.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | acupuncture to lower extremity postoperatively |
|
| sham acupuncture | Sham Comparator | sham acupuncture at same sites. |
|
| control | No Intervention | no acupuncture, otherwise the same care and measurements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | standardized acupuncture intended to improve blood flow and reduce edema to lower extremity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transcutaneous tissue oxygen tension | postoperative days 0, 1, 2, 3 |
| Measure | Description | Time Frame |
|---|---|---|
| ASEPSIS score | postoperatively | |
| Transcutaneous tissue microperfusion | postoperative day 0, 1, 2, 3 | |
| Pain visual analogue scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| complications of acupuncture | duration of study |
Inclusion Criteria:
Exclusion Criteria:
Pre-operative
Post-operative
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| Name | Affiliation | Role |
|---|---|---|
| Harriet W Hopf, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-0648 | United States |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D013530 | Surgical Wound Infection |
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Other | standardized sham acupuncture at same sites as acupuncture. |
|
| postoperative days 0, 1, 2, 3 |
| 24-hour narcotic usage | postoperative days 0, 1, 2, 3 |
| Anxiety VAS | postoperative days 0, 1, 2, 3 |
| State-Trait Anxiety Inventory (STAI) | preoperative and postoperative |
| Serum epinephrine | postoperative |
| Serum cortisol | postoperative |
| Traditional Chinese Medicine pulse and tongue assessment | postoperative |
| Patient belief and expectancy survey | preoperative |