NCT00260494

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

November 29, 2005

Last Update Submit

July 22, 2013

Conditions

Postoperative ComplicationsSurgical Wound InfectionSurgical Wound Dehiscence

Keywords

Cardiac Surgical Proceduresopen saphenous vein graft harvest woundsPostoperative ComplicationsSurgical Wound InfectionSurgical Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

  • Transcutaneous tissue oxygen tension

    postoperative days 0, 1, 2, 3

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Other Outcomes (1)

  • complications of acupuncture

    duration of study

Study Arms (3)

acupuncture

EXPERIMENTAL

acupuncture to lower extremity postoperatively

Other: acupuncture

sham acupuncture

SHAM COMPARATOR

sham acupuncture at same sites.

Other: sham acupuncture

control

NO INTERVENTION

no acupuncture, otherwise the same care and measurements

Interventions

acupunctureOTHER

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

acupuncture
sham acupunctureOTHER

standardized sham acupuncture at same sites as acupuncture.

sham acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0648, United States

Location

MeSH Terms

Conditions

Postoperative ComplicationsSurgical Wound InfectionSurgical Wound Dehiscence

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWound InfectionInfections

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Harriet W Hopf, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

March 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

US(1)