Acupuncture and Post-Surgical Wound Healing
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest |
- Transcutaneous tissue oxygen tension
- 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
| 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:
- without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00260494 History of Changes |
| Other Study ID Numbers: | H7546-25444 |
| Study First Received: | November 29, 2005 |
| Last Updated: | March 20, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Cardiac Surgical Procedures open saphenous vein graft harvest wounds Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence |
Additional relevant MeSH terms:
|
Postoperative Complications Surgical Wound Dehiscence Surgical Wound Infection Wound Infection |
Pathologic Processes Infection Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013