Acupuncture and Post-Surgical Wound Healing

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Postoperative Complications; Surgical Wound Dehiscence; Surgical Wound Infection

Treatments: Other: acupuncture; Other: sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00260494

H7546-25444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 3 patient groups

acupuncture

Experimental group

Description:

acupuncture to lower extremity postoperatively

Treatment:

Other: acupuncture

sham acupuncture

Sham Comparator group

Description:

sham acupuncture at same sites.

Treatment:

Other: sham acupuncture

control

No Intervention group

Description:

no acupuncture, otherwise the same care and measurements