Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 7:38 AM
Study NCT ID:
NCT00482469
Status:
COMPLETED
Last Update Posted:
2009-01-07
First Post:
2007-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DIEP-Flap as a Model of Ischemia-Reperfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Frozen tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-06', 'studyFirstSubmitDate': '2007-06-04', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ischemia-reperfusion', 'ischemia', 'reperfusion', 'DIEP-flap', 'flap'], 'conditions': ['Ischemia-Reperfusion']}, 'referencesModule': {'references': [{'pmid': '22789619', 'type': 'DERIVED', 'citation': 'van den Heuvel MG, Bast A, Haenen GR, Ambergen AW, Mermans JF, van der Hulst RR. The role of antioxidants in ischaemia-reperfusion in a human DIEP flap model. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1706-11. doi: 10.1016/j.bjps.2012.06.010. Epub 2012 Jul 11.'}, {'pmid': '21233705', 'type': 'DERIVED', 'citation': 'van den Heuvel MG, Mermans JF, Ambergen AW, van der Hulst RR. Perfusion of the deep inferior epigastric perforator flap measured by laser Doppler imager. Ann Plast Surg. 2011 Jun;66(6):648-53. doi: 10.1097/SAP.0b013e3181e37bc8.'}]}, 'descriptionModule': {'briefSummary': 'It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical patients hospitalized for surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral\n* is aged 18 years or older\n\nExclusion Criteria:\n\n* diabetes mellitus\n* diseases of the kidneys\n* diseases of the liver\n* patients who are taking immunosuppressants'}, 'identificationModule': {'nctId': 'NCT00482469', 'briefTitle': 'The DIEP-Flap as a Model of Ischemia-Reperfusion', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The DIEP-Flap as a Model of Ischemia-Reperfusion', 'orgStudyIdInfo': {'id': 'MEC 07-2-004'}}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O. Box 5800-6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Department of Plastic and Reconstructive surgery, Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'René R Van der Hulst, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maastricht University Hospital'}, {'name': 'Marieke GW Van den Heuvel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. R. van der Hulst, M.D.', 'oldOrganization': 'University Hospital Maastricht'}}}}