Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-27 @ 8:06 AM
Study NCT ID:
NCT00819260
Status:
TERMINATED
Last Update Posted:
2013-05-20
First Post:
2009-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006965', 'term': 'Hyperplasia'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carolyn.kerrigan@hitchcock.org', 'phone': '603-650-5148', 'title': 'Carolyn L. Kerrigan MD', 'organization': 'Dartmouth-Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Infected seroma', 'notes': 'Required operative evacuation, antibiotics and prolonged wound care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time for Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side'}, {'id': 'OG001', 'title': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '31', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day of surgery', 'description': 'Time to complete the breast reduction per breast.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.'}, {'type': 'SECONDARY', 'title': 'Volume of Drainage in Surgical Drains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side'}, {'id': 'OG001', 'title': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within one week of surgery', 'description': 'An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.', 'unitOfMeasure': 'mL/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the study.'}, {'type': 'SECONDARY', 'title': 'Pain Level in Surgical Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side'}, {'id': 'OG001', 'title': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '4', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'first week after surgery', 'description': 'An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all study participants'}, {'type': 'SECONDARY', 'title': 'Hematoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side'}, {'id': 'OG001', 'title': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first day after surgery', 'description': 'A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'entire study population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.', 'preAssignmentDetails': 'Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '0', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Significant result achieved after enrollment of 31 of planned 50 subjects.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2009-01-06', 'resultsFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-17', 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for Operation', 'timeFrame': 'day of surgery', 'description': 'Time to complete the breast reduction per breast.'}], 'secondaryOutcomes': [{'measure': 'Volume of Drainage in Surgical Drains', 'timeFrame': 'within one week of surgery', 'description': 'An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.'}, {'measure': 'Pain Level in Surgical Sites', 'timeFrame': 'first week after surgery', 'description': 'An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.'}, {'measure': 'Hematoma', 'timeFrame': 'first day after surgery', 'description': 'A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mammaplasty', 'Electrocoagulation', 'Breast'], 'conditions': ['Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.\n\nThe three metrics are:\n\n1. the time taken to complete the operation\n2. drainage volume in the days immediately following surgery,\n3. patient pain in the days immediately following surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.\n\nExclusion Criteria:\n\n* under 18 years of age'}, 'identificationModule': {'nctId': 'NCT00819260', 'briefTitle': 'Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery', 'orgStudyIdInfo': {'id': '1182DF9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Harmonic Reduced Breast', 'description': 'harmonic scalpel used to reduce breast on that side', 'interventionNames': ['Device: Harmonic Scalpel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrocautery Reduced Breast', 'description': 'Electrocautery (current practice = control) used to reduce breast on that side', 'interventionNames': ['Device: Electrocautery']}], 'interventions': [{'name': 'Harmonic Scalpel', 'type': 'DEVICE', 'description': 'harmonic scalpel used to reduce breast on this side', 'armGroupLabels': ['Harmonic Reduced Breast']}, {'name': 'Electrocautery', 'type': 'DEVICE', 'description': 'Electrocautery used to reduce breast on this side', 'armGroupLabels': ['Electrocautery Reduced Breast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Carolyn L Kerrigan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DHMC'}, {'name': 'Todd E Burdette, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DHMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}