Acupuncture and Post-Surgical Wound Healing - Full Text View

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

MedlinePlus related topics:

Acupuncture Coronary Artery Bypass Surgery Surgery

U.S. FDA Resources

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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Transcutaneous tissue oxygen tension

Secondary Outcome Measures:

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

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:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260494

Contacts


Contact: Harriet W Hopf, MD	(801) 205-1013	harriet.hopf@hsc.utah.edu

Contact: Jodi D Sherman, MD	(415) 203-6500	shermanj@stanford.edu

Locations


United States, California
	University of California, San Francisco	Recruiting
	San Francisco, California, United States, 94143-0648

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Harriet W Hopf, MD	University of California, San Francisco

More Information

Study ID Numbers:	H7546-25444
First Received:	November 29, 2005
Last Updated:	March 20, 2007
ClinicalTrials.gov Identifier:	NCT00260494
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

Study placed in the following topic categories:

Surgical Wound Dehiscence

Postoperative Complications

Wounds and Injuries

Surgical Wound Infection

Wound Infection

Additional relevant MeSH terms:

Pathologic Processes

Disorders of Environmental Origin

Infection

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00260494