search
Back to results

Acupuncture and Post-Surgical Wound Healing

Primary Purpose

Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
sham acupuncture
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Cardiac Surgical Procedures, open saphenous vein graft harvest wounds, Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

acupuncture

sham acupuncture

control

Arm Description

acupuncture to lower extremity postoperatively

sham acupuncture at same sites.

no acupuncture, otherwise the same care and measurements

Outcomes

Primary Outcome Measures

Transcutaneous tissue oxygen tension

Secondary Outcome Measures

ASEPSIS score
Transcutaneous tissue microperfusion
Pain visual analogue scale (VAS)
24-hour narcotic usage
Anxiety VAS
State-Trait Anxiety Inventory (STAI)
Serum epinephrine
Serum cortisol
Traditional Chinese Medicine pulse and tongue assessment
Patient belief and expectancy survey

Full Information

First Posted
November 29, 2005
Last Updated
July 22, 2013
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT00260494
Brief Title
Acupuncture and Post-Surgical Wound Healing
Official Title
Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
No difference in primary outcomes at interim analysis.
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence
Keywords
Cardiac Surgical Procedures, open saphenous vein graft harvest wounds, Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
acupuncture to lower extremity postoperatively
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
sham acupuncture at same sites.
Arm Title
control
Arm Type
No Intervention
Arm Description
no acupuncture, otherwise the same care and measurements
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
standardized sham acupuncture at same sites as acupuncture.
Primary Outcome Measure Information:
Title
Transcutaneous tissue oxygen tension
Time Frame
postoperative days 0, 1, 2, 3
Secondary Outcome Measure Information:
Title
ASEPSIS score
Time Frame
postoperatively
Title
Transcutaneous tissue microperfusion
Time Frame
postoperative day 0, 1, 2, 3
Title
Pain visual analogue scale (VAS)
Time Frame
postoperative days 0, 1, 2, 3
Title
24-hour narcotic usage
Time Frame
postoperative days 0, 1, 2, 3
Title
Anxiety VAS
Time Frame
postoperative days 0, 1, 2, 3
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
preoperative and postoperative
Title
Serum epinephrine
Time Frame
postoperative
Title
Serum cortisol
Time Frame
postoperative
Title
Traditional Chinese Medicine pulse and tongue assessment
Time Frame
postoperative
Title
Patient belief and expectancy survey
Time Frame
preoperative
Other Pre-specified Outcome Measures:
Title
complications of acupuncture
Time Frame
duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet W Hopf, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0648
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Acupuncture and Post-Surgical Wound Healing

We'll reach out to this number within 24 hrs