Acupuncture and Post-Surgical Wound Healing

Sponsor

University of California, San Francisco (Other)

Overall Status

Terminated

CT.gov ID

NCT00260494

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications Surgical Wound Infection Surgical Wound Dehiscence	Other: acupuncture Other: sham acupuncture	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Transcutaneous tissue oxygen tension [postoperative days 0, 1, 2, 3]

Secondary Outcome Measures

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

complications of acupuncture [duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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