Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-17 @ 8:55 AM
Study NCT ID:
NCT00984269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-28
First Post:
2009-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymphedema 15% change from pre-post in girth', 'timeFrame': 'Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year'}], 'secondaryOutcomes': [{'measure': 'Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications', 'timeFrame': '10-14 days, 6 weeks, 3 months, 6 months, and 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.\n* Patients ages 18 and over\n* Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of \\< 20 minutes.\n* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment\n* Patients under the age of 18\n* Patients who are pregnant\n* Patients presenting for an elective hand procedure with an anticipated tourniquet time of \\> 20 minutes.\n* Patients who are on a blood thinner which cannot be stopped prior to surgery\n* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.'}, 'identificationModule': {'nctId': 'NCT00984269', 'briefTitle': 'Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'OrthoCarolina Research Institute, Inc.'}, 'officialTitle': 'Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial', 'orgStudyIdInfo': {'id': '08-09-14B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Tourniquet', 'description': 'Patients undergoing hand/wrist surgery without the use of a tourniquet.'}, {'type': 'EXPERIMENTAL', 'label': 'Tourniquet', 'description': 'Patients undergoing hand/wrist surgery with the use of a tourniquet.', 'interventionNames': ['Procedure: Tourniquet Use']}], 'interventions': [{'name': 'Tourniquet Use', 'type': 'PROCEDURE', 'description': 'Patients undergoing hand/wrist surgery with or without a tourniquet', 'armGroupLabels': ['Tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical School', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoCarolina Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}