Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT00260494
Status:
TERMINATED
Last Update Posted:
2013-07-23
First Post:
2005-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture and Post-Surgical Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D013529', 'term': 'Surgical Wound Dehiscence'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'No difference in primary outcomes at interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2005-11-29', 'studyFirstSubmitQcDate': '2005-11-29', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'complications of acupuncture', 'timeFrame': 'duration of study'}], 'primaryOutcomes': [{'measure': 'Transcutaneous tissue oxygen tension', 'timeFrame': 'postoperative days 0, 1, 2, 3'}], 'secondaryOutcomes': [{'measure': 'ASEPSIS score', 'timeFrame': 'postoperatively'}, {'measure': 'Transcutaneous tissue microperfusion', 'timeFrame': 'postoperative day 0, 1, 2, 3'}, {'measure': 'Pain visual analogue scale (VAS)', 'timeFrame': 'postoperative days 0, 1, 2, 3'}, {'measure': '24-hour narcotic usage', 'timeFrame': 'postoperative days 0, 1, 2, 3'}, {'measure': 'Anxiety VAS', 'timeFrame': 'postoperative days 0, 1, 2, 3'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'preoperative and postoperative'}, {'measure': 'Serum epinephrine', 'timeFrame': 'postoperative'}, {'measure': 'Serum cortisol', 'timeFrame': 'postoperative'}, {'measure': 'Traditional Chinese Medicine pulse and tongue assessment', 'timeFrame': 'postoperative'}, {'measure': 'Patient belief and expectancy survey', 'timeFrame': 'preoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Surgical Procedures', 'open saphenous vein graft harvest wounds', 'Postoperative Complications', 'Surgical Wound Infection', 'Surgical Wound Dehiscence'], 'conditions': ['Postoperative Complications', 'Surgical Wound Infection', 'Surgical Wound Dehiscence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n1. without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and\n2. hypoxic conditions, unfortunately, are common in chronic and acute wounds, and often result from subcutaneous vasoconstriction.\n\nSympathetic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age \\> 18)\n* Males/females\n* All races\n* Elective/urgent CABG\n* Open saphenous vein graft harvest\n* University of California, San Francisco, and additional approved hospital sites\n\nExclusion Criteria:\n\nPre-operative\n\n* Emergent CABG, valves\n* History of peripheral vascular surgery, amputation, severe peripheral neuropathy, immunocompromise, or end-stage renal disease requiring hemodialysis\n\nPost-operative\n\n* Postoperative day 1 (POD1) hemodynamic instability\n* ≥ 4u packed red blood cells transfusion (PRBC)/8 hours, CT \\> 200cc/hour 3 hours, \\> 2 pressors\n* Prolonged intubation (\\> POD1)\n* Altered mental status'}, 'identificationModule': {'nctId': 'NCT00260494', 'briefTitle': 'Acupuncture and Post-Surgical Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Acupuncture and Post-Surgical Wound Healing in Coronary Artery Bypass Graft Patients Undergoing Open Saphenous Vein Graft Harvest', 'orgStudyIdInfo': {'id': 'H7546-25444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'description': 'acupuncture to lower extremity postoperatively', 'interventionNames': ['Other: acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupuncture', 'description': 'sham acupuncture at same sites.', 'interventionNames': ['Other: sham acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no acupuncture, otherwise the same care and measurements'}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'description': 'standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.', 'armGroupLabels': ['acupuncture']}, {'name': 'sham acupuncture', 'type': 'OTHER', 'description': 'standardized sham acupuncture at same sites as acupuncture.', 'armGroupLabels': ['sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-0648', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Harriet W Hopf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}