Acupuncture and Post-Surgical Wound Healing

NCT ID: NCT00260494

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-07-31

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.

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.

Conditions

Postoperative Complications; Surgical Wound Infection; Surgical Wound Dehiscence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

acupuncture

acupuncture to lower extremity postoperatively

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.

sham acupuncture

sham acupuncture at same sites.

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: OTHER

standardized sham acupuncture at same sites as acupuncture.

control

no acupuncture, otherwise the same care and measurements

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.

Intervention Type: OTHER

sham acupuncture

standardized sham acupuncture at same sites as acupuncture.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet W Hopf, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

H7546-25444

Identifier Type: -

Identifier Source: org_study_id