Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT02390661
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2015-03-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-21', 'releaseDate': '2025-05-05'}], 'estimatedResultsFirstSubmitDate': '2025-05-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D049291', 'term': 'Seroma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of lumpectomy cavity seroma', 'timeFrame': '1 month and 4 months', 'description': 'The patient will be evaluated by physical exam and ultrasound of the affected breast.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['seroma', 'accelerated partial breast irradiation (APBI)', 'breast lumpectomy', 'breast cancer'], 'conditions': ['Infected Seroma After Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. The drain will be placed in the same site used for the APBI device and no additional surgery will be performed. The drain will remain for 2-3 days and it will be removed by the patient at home. They will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in the rate of seroma formation after the APBI device removal if a drain is placed.', 'detailedDescription': 'The proposed study is randomised controlled trial where informed and consenting patients who have an APBI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and a experimental group that would have a penrose drain placed under sterile conditions at the time of removal of their device. The procedure will be performed at the MSU Surgery outpatient clinic by residents, the senior investigator or a trained nurse/PA. Additional data will be collected on each patient from their medical record including demographic data, cancer diagnosis, lesion size, date of procedure, date Mammosite/SAVI was inserted and removed, total dose of radiation, ER, PR, HER2Neu status, and any chemotherapy or hormone therapy being administered. Drains will remain in place for 2-3 days and will be removed by the patient upon removing the dressing. Patients will continue their antibiotic regimen prescribed while the APBI device was in place for the 2-3 days the drain is in place for infection prophylaxis. Patients will be followed for 4 weeks to determine if a seroma or other complication has developed. Patients in both the experimental and control groups will have the same standard follow up and monitoring for seroma development with the use of ultrasound. All postop cancer care will be standard and this study will not alter or delay any aspect of breast cancer treatment. Statistics will be performed and reported based upon data collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of breast cancer\n* received accelerated partial breast irradiation\n\nExclusion Criteria:\n\n* any metastatic breast cancer\n* infection\n* skin with radiation injury'}, 'identificationModule': {'nctId': 'NCT02390661', 'briefTitle': 'Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal', 'orgStudyIdInfo': {'id': '13-931M; i044456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No drain', 'description': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'Penrose drain placement', 'description': 'Placement of a penrose drain after irradiation catheter is removed', 'interventionNames': ['Device: Penrose drain placement']}], 'interventions': [{'name': 'Penrose drain placement', 'type': 'DEVICE', 'description': 'A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter', 'armGroupLabels': ['Penrose drain placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University Dept Surgery/Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}], 'overallOfficials': [{'name': 'Harvey Bumpers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University, CHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Harvey Bumpers', 'investigatorAffiliation': 'Michigan State University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-05', 'type': 'RELEASE'}, {'date': '2025-05-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Harvey Bumpers, Professor of Surgery, Michigan State University'}}}}