Acupuncture and Post-Surgical Wound Healing

Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications; Surgical Wound Infection; Surgical Wound Dehiscence
• Intervention / Treatment: Other: acupuncture; Other: sham acupuncture

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:

1. without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and
2. 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
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture; acupuncture to lower extremity postoperatively	Other: acupuncture; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transcutaneous tissue oxygen tension	postoperative days 0, 1, 2, 3

Secondary Outcome Measures

Outcome Measure	Time Frame
ASEPSIS score	postoperatively
Transcutaneous tissue microperfusion	postoperative day 0, 1, 2, 3
Pain visual analogue scale (VAS)	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

Other Outcome Measures

Outcome Measure	Time Frame
complications of acupuncture	duration of study

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: November 29, 2005
• First Submitted That Met QC Criteria: November 29, 2005
• First Posted (Estimate): December 1, 2005

Study Record Updates

• Last Update Posted (Estimate): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Postoperative Complications; Cardiac Surgical Procedures; Surgical Wound Infection; Surgical Wound Dehiscence; open saphenous vein graft harvest wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Wounds and Injuries; Surgical Wound; Postoperative Complications; Surgical Wound Infection; Wound Infection; Surgical Wound Dehiscence
• Other Study ID Numbers: H7546-25444