Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 3:18 AM
Study NCT ID:
NCT01092468
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-02', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flap elevation time: from identification of skin perforator to completion of dissection to main pedicle', 'timeFrame': '1 hour after completion of flap elevation'}], 'secondaryOutcomes': [{'measure': 'intraoperative complications: bleeding, perforator injury (thermal, mechanical)', 'timeFrame': '1 hour after completion of flap elevation'}, {'measure': 'postoperative drainage amount', 'timeFrame': '1 week after flap inset'}, {'measure': 'postoperative pain measured by visual analogue scale (VAS)', 'timeFrame': '1 week after completion of flap elevation'}]}, 'conditionsModule': {'keywords': ['cancer', 'reconstruction', 'free flap', 'surgery'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* head and neck reconstruction with perforator flap\n* informed consent from the patient\n\nExclusion Criteria:\n\n* coagulation problem\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT01092468', 'briefTitle': 'Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap', 'orgStudyIdInfo': {'id': '2009-08-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Diathermy', 'description': 'Perforator flap elevation using conventional diathermy technique', 'interventionNames': ['Procedure: Diathermy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Harmonic Scalpel', 'description': 'Perforator flap elevation using Harmonic Scalpel', 'interventionNames': ['Procedure: Harmonic Scalpel']}], 'interventions': [{'name': 'Diathermy', 'type': 'PROCEDURE', 'description': 'flap dissection with conventional diathermy', 'armGroupLabels': ['Diathermy']}, {'name': 'Harmonic Scalpel', 'type': 'PROCEDURE', 'description': 'flap dissection using harmonic scalpel (FOCUS)', 'armGroupLabels': ['Harmonic Scalpel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Man Ki Chung', 'investigatorAffiliation': 'Samsung Medical Center'}}}}