Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-26 @ 9:52 AM
Study NCT ID:
NCT00223132
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suture Granuloma in Body Contouring Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['bariatric surgery', 'body contouring', 'skin laxity', 'plastic surgery', 'suture granuloma', 'absorbable sutures'], 'conditions': ['Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.', 'detailedDescription': 'Bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. Consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. Patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck.\n\nA major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. Long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. While absorbable sutures are preferred, they can result in suture granuloma and extrusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and women 18 years and older\n\nExclusion Criteria:\n\nSubjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side Subjects who cancel their surgery'}, 'identificationModule': {'nctId': 'NCT00223132', 'briefTitle': 'Suture Granuloma in Body Contouring Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'orgStudyIdInfo': {'id': 'SYN04002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Absorbable sutures', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Donna Doran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic - MITG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}}}}