Acupuncture and Post-Surgical Wound Healing

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00260494
• Other study ID #: H7546-25444
• Status: Terminated
• Phase: N/A
• First received: November 29, 2005
• Last updated: July 22, 2013
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: July 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Complications
• Surgical Wound Dehiscence
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• acupuncture
standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
• sham acupuncture
standardized sham acupuncture at same sites as acupuncture.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complications of acupuncture		duration of study	Yes
Primary	Transcutaneous tissue oxygen tension		postoperative days 0, 1, 2, 3	No
Secondary	ASEPSIS score		postoperatively	No
Secondary	Transcutaneous tissue microperfusion		postoperative day 0, 1, 2, 3	No
Secondary	Pain visual analogue scale (VAS)		postoperative days 0, 1, 2, 3	No
Secondary	24-hour narcotic usage		postoperative days 0, 1, 2, 3	No
Secondary	Anxiety VAS		postoperative days 0, 1, 2, 3	No
Secondary	State-Trait Anxiety Inventory (STAI)		preoperative and postoperative	No
Secondary	Serum epinephrine		postoperative	No
Secondary	Serum cortisol		postoperative	No
Secondary	Traditional Chinese Medicine pulse and tongue assessment		postoperative	No
Secondary	Patient belief and expectancy survey		preoperative	No