Postoperative ComplicationsNCT00260494
Acupuncture and Post-Surgical Wound Healing
A study testing acupuncture in people with Postoperative Complications and Surgical Wound Infection, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143-0648
About this study
Official title: Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
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.
Read the 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.
- Being tested
- acupuncture, sham acupuncture
- Keywords
- Cardiac Surgical Procedures, open saphenous vein graft harvest wounds, Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence
- Medical subject headings
- Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
sham acupunctureOther
standardized sham acupuncture at same sites as acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | acupuncture to lower extremity postoperatively Receives: Other: acupuncture |
| sham acupuncture | Sham comparator | sham acupuncture at same sites. Receives: Other: sham acupuncture |
| control | No intervention | no acupuncture, otherwise the same care and measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous tissue oxygen tension
Measured: postoperative days 0, 1, 2, 3
Secondary outcomes (10)
ASEPSIS score
Measured: postoperatively
Transcutaneous tissue microperfusion
Measured: postoperative day 0, 1, 2, 3
Pain visual analogue scale (VAS)
Measured: postoperative days 0, 1, 2, 3
24-hour narcotic usage
Measured: postoperative days 0, 1, 2, 3
Anxiety VAS
Measured: postoperative days 0, 1, 2, 3
State-Trait Anxiety Inventory (STAI)
Measured: preoperative and postoperative
Serum epinephrine
Measured: postoperative
Serum cortisol
Measured: postoperative
Traditional Chinese Medicine pulse and tongue assessment
Measured: postoperative
Patient belief and expectancy survey
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2006
- Study completionJul 2006
Why it stopped: No difference in primary outcomes at interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet W Hopf, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260494
- Sponsor's protocol ID
- H7546-25444
- Status last verified
- Jul 2013
- First submitted
- 29 Nov 2005
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest
- ClinicalTrials.gov ID
- NCT00260494
- Acronym / sponsor ID
- H7546-25444
- Keywords
- Cardiac Surgical Procedures, open saphenous vein graft harvest wounds, Postoperative Complications, Surgical Wound Infection, Surgical Wound Dehiscence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No difference in primary outcomes at interim analysis.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: acupunctureacupuncture to lower extremity postoperatively |
| sham acupuncture | Sham comparator | Other: sham acupuncturesham acupuncture at same sites. |
| control | No intervention | –no acupuncture, otherwise the same care and measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age > 18)
- Males/females
- All races
- Elective/urgent CABG
- Open saphenous vein graft harvest
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturestandardized acupuncture intended to improve blood flow and reduce edema to lower extremity. | Other | acupuncture |
| sham acupuncturestandardized sham acupuncture at same sites as acupuncture. | Other | sham acupuncture |
Primary outcome
Transcutaneous tissue oxygen tension
Time frame: postoperative days 0, 1, 2, 3
10 secondary outcomes
ASEPSIS score
Time frame: postoperatively
Transcutaneous tissue microperfusion
Time frame: postoperative day 0, 1, 2, 3
Pain visual analogue scale (VAS)
Time frame: postoperative days 0, 1, 2, 3
24-hour narcotic usage
Time frame: postoperative days 0, 1, 2, 3
Anxiety VAS
Time frame: postoperative days 0, 1, 2, 3
State-Trait Anxiety Inventory (STAI)
Time frame: preoperative and postoperative
Serum epinephrine
Time frame: postoperative
Serum cortisol
Time frame: postoperative
Traditional Chinese Medicine pulse and tongue assessment
Time frame: postoperative
Patient belief and expectancy survey
Time frame: preoperative
Results and safety
The study was stopped early (reason given: No difference in primary outcomes at interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet W Hopf, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Postoperative Complications and Surgical Wound Infection, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No difference in primary outcomes at interim analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous tissue oxygen tension (time frame: postoperative days 0, 1, 2, 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013; AzTrials last refreshed its copy on 2 Nov 2026.