Acupuncture and Post-Surgical Wound Healing
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|ClinicalTrials.gov Identifier: NCT00260494|
Recruitment Status : Terminated (No difference in primary outcomes at interim analysis.)
First Posted : December 1, 2005
Last Update Posted : July 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence||Other: acupuncture Other: sham acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
acupuncture to lower extremity postoperatively
standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
Sham Comparator: sham acupuncture
sham acupuncture at same sites.
Other: sham acupuncture
standardized sham acupuncture at same sites as acupuncture.
No Intervention: control
no acupuncture, otherwise the same care and measurements
- Transcutaneous tissue oxygen tension [ Time Frame: postoperative days 0, 1, 2, 3 ]
- ASEPSIS score [ Time Frame: postoperatively ]
- Transcutaneous tissue microperfusion [ Time Frame: postoperative day 0, 1, 2, 3 ]
- Pain visual analogue scale (VAS) [ Time Frame: postoperative days 0, 1, 2, 3 ]
- 24-hour narcotic usage [ Time Frame: postoperative days 0, 1, 2, 3 ]
- Anxiety VAS [ Time Frame: postoperative days 0, 1, 2, 3 ]
- State-Trait Anxiety Inventory (STAI) [ Time Frame: preoperative and postoperative ]
- Serum epinephrine [ Time Frame: postoperative ]
- Serum cortisol [ Time Frame: postoperative ]
- Traditional Chinese Medicine pulse and tongue assessment [ Time Frame: postoperative ]
- Patient belief and expectancy survey [ Time Frame: preoperative ]
- complications of acupuncture [ Time Frame: duration of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260494
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0648|
|Principal Investigator:||Harriet W Hopf, MD||University of California, San Francisco|