Acupuncture and Post-Surgical Wound Healing

This study has been terminated.
(No difference in primary outcomes at interim analysis.)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00260494
First received: November 29, 2005
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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 Intervention
Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence
Other: acupuncture
Other: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Transcutaneous tissue oxygen tension [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ASEPSIS score [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
  • Transcutaneous tissue microperfusion [ Time Frame: postoperative day 0, 1, 2, 3 ] [ Designated as safety issue: No ]
  • Pain visual analogue scale (VAS) [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
  • 24-hour narcotic usage [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
  • Anxiety VAS [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory (STAI) [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]
  • Serum epinephrine [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • Serum cortisol [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • Traditional Chinese Medicine pulse and tongue assessment [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • Patient belief and expectancy survey [ Time Frame: preoperative ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • complications of acupuncture [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: March 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260494

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Harriet W Hopf, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00260494     History of Changes
Other Study ID Numbers: H7546-25444
Study First Received: November 29, 2005
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Cardiac Surgical Procedures
open saphenous vein graft harvest wounds
Postoperative Complications
Surgical Wound Infection
Surgical Wound Dehiscence

Additional relevant MeSH terms:
Postoperative Complications
Surgical Wound Dehiscence
Surgical Wound Infection
Wound Infection
Pathologic Processes
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014