Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT02677012
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-11', 'studyFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of fat processed defined as the volume of fat harvested per minute', 'timeFrame': '1 day', 'description': 'Study data will be collected and managed using the Research Electronic Data Capture. This study will measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three adipose tissue processing techniques.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Status Unknown']}, 'referencesModule': {'references': [{'pmid': '33890883', 'type': 'DERIVED', 'citation': 'Hanson SE, Garvey PB, Chang EI, Reece GP, Liu J, Baumann DP, Butler CE. A Randomized Prospective Time and Motion Comparison of Techniques to Process Autologous Fat Grafts. Plast Reconstr Surg. 2021 May 1;147(5):1035-1044. doi: 10.1097/PRS.0000000000007827.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "This randomized clinical trial studies and compares 3 techniques in performing autologous fat grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of the body changed by previous surgery and inserted into another part of the body. AFG, also called fat injections or fat transplant, is a procedure in which an individual's own body fat (usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare 3 techniques for processing the fat tissue collected during surgery and the length of time needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to complete them during surgery may help doctors determine the best technique to perform fat grafting in the future.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three aforementioned adipose tissue processing techniques.\n\nSECONDARY OBJECTIVES:\n\nI. To measure total fat grafting time: time from initiation of fat harvesting to the end of fat injection.\n\nII. To measure volume of fat processed: volume of fat obtained after fat processing.\n\nIII. To measure total operation room (OR) time: time from patient entry into the OR (or when the patient barcode is read on entering the OR) to the time at which the patient leaves the OR.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low velocity spinning using a commercially available system that washes the lipoaspirate with lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal force and suction.\n\nARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.\n\nARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and aqueous layers discarded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with available harvest sites for fat grafting\n* Patients with body mass index (BMI) \\> 20\n* Estimated harvested fat volume \\>= 100 cc\n* Patients are willing and able to give consent\n\nExclusion Criteria:\n\n* Patients with active cancer, including primary cancer, recurrent cancer, or locally or distant metastasis\n* Patients who are unable to provide consent\n* Patients who are suspected or known to be pregnant'}, 'identificationModule': {'nctId': 'NCT02677012', 'briefTitle': 'Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts', 'orgStudyIdInfo': {'id': '2015-0006'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00346', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2015-0006', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm I (RESOLVE TM)', 'description': "Patients undergo AFG reconstructive surgery comprising washing and low velocity spinning using a commercially available system that washes the lipoaspirate with lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal force and suction.", 'interventionNames': ['Procedure: Autologous Fat Graft', 'Procedure: Reconstructive Surgery']}, {'label': 'Arm II (Cytori PureGraft TM)', 'description': 'Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated RL and the non-fat material is filtered through mesh.', 'interventionNames': ['Procedure: Autologous Fat Graft', 'Procedure: Reconstructive Surgery']}, {'label': 'Arm III (Coleman technique)', 'description': 'Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 rpm for 3 minutes with the resulting oil and aqueous layers discarded.', 'interventionNames': ['Procedure: Autologous Fat Graft', 'Procedure: Reconstructive Surgery']}], 'interventions': [{'name': 'Autologous Fat Graft', 'type': 'PROCEDURE', 'otherNames': ['Autologous Fat Cell Transplantation', 'Autologous Fat Injection', 'Autologous Fat Transfer'], 'description': 'Undergo AFG using the RESOLVE TM technique', 'armGroupLabels': ['Arm I (RESOLVE TM)']}, {'name': 'Autologous Fat Graft', 'type': 'PROCEDURE', 'otherNames': ['Autologous Fat Cell Transplantation', 'Autologous Fat Injection', 'Autologous Fat Transfer'], 'description': 'Undergo AFG using the Cytori PureGraft TM technique', 'armGroupLabels': ['Arm II (Cytori PureGraft TM)']}, {'name': 'Autologous Fat Graft', 'type': 'PROCEDURE', 'otherNames': ['Autologous Fat Cell Transplantation', 'Autologous Fat Injection', 'Autologous Fat Transfer'], 'description': 'Undergo AFG using the Coleman technique', 'armGroupLabels': ['Arm III (Coleman technique)']}, {'name': 'Reconstructive Surgery', 'type': 'PROCEDURE', 'otherNames': ['Reconstruction'], 'description': 'Undergo reconstructive surgery', 'armGroupLabels': ['Arm I (RESOLVE TM)', 'Arm II (Cytori PureGraft TM)', 'Arm III (Coleman technique)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Summer Hanson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}