Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT01979757
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002498', 'term': 'Centrifugation'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatgrafting to a Breast After Breast Conserving Therapy']}, 'descriptionModule': {'briefSummary': 'Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity. Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics, USA) is a new method that involves washing and filtering the fat to prepare the graft. The investigators compared the subjective and objective outcomes of two fat-processing methods, centrifugation and PureGraft filtration.\n\nThirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT in our department between April 2011 and September 2012. The patients were preoperatively divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15 received fatgrafts processed by washing in PureGraft bags. The patients were followed up for 12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q questionnaire to all the patients both preoperatively and one year postoperatively. The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* State after breast conserving therapy'}, 'identificationModule': {'nctId': 'NCT01979757', 'briefTitle': 'Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast', 'organization': {'class': 'OTHER', 'fullName': 'Bulovka Hospital'}, 'officialTitle': 'Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy', 'orgStudyIdInfo': {'id': 'CentPure'}, 'secondaryIdInfos': [{'id': '268011', 'type': 'OTHER_GRANT', 'domain': 'Grant Agency of Charles University in Prague'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Centrifugation', 'description': 'Patients recieved fatgraft processed by Centrifugation', 'interventionNames': ['Other: Centrifugation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Puregraft', 'description': 'Patients recieved fatgraft processed by Puregraft', 'interventionNames': ['Other: Puregraft']}], 'interventions': [{'name': 'Puregraft', 'type': 'OTHER', 'armGroupLabels': ['Puregraft']}, {'name': 'Centrifugation', 'type': 'OTHER', 'armGroupLabels': ['Centrifugation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '180 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Bulovka Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Ondrej Mestak, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charles University, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulovka Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Ondrej Mestak M.D.', 'investigatorAffiliation': 'Bulovka Hospital'}}}}