Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 11:20 AM
Study NCT ID:
NCT01315392
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2011-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infection rate', 'description': 'defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.'}, {'measure': 'hospital readmissions', 'description': 'need for additional procedures and hospital readmissions related to the index injury will be documented'}, {'measure': 'tibial fracture healing', 'description': 'evidence of bridging callus on three of four cortices assessed by biplanar radiograph'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type II and IIa Open Tibia Fractures']}, 'descriptionModule': {'briefSummary': 'Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gustilo type II-IIIa tibia fracture\n* age greater than 15 years\n* fractures amenable to intramedullary nailing\n\nExclusion Criteria:\n\n* excessive wound contamination\n* patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention\n* impaired or absent consciousness\n* refusal of consent'}, 'identificationModule': {'nctId': 'NCT01315392', 'briefTitle': 'A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study', 'orgStudyIdInfo': {'id': 'OTAOREF2000MJB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'delayed closure', 'description': 'wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure.', 'interventionNames': ['Procedure: delayed closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'immediate wound closure', 'description': 'traumatic and surgical wounds closed at initial surgical intervention', 'interventionNames': ['Procedure: immediate wound closure']}], 'interventions': [{'name': 'delayed closure', 'type': 'PROCEDURE', 'description': 'wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure.', 'armGroupLabels': ['delayed closure']}, {'name': 'immediate wound closure', 'type': 'PROCEDURE', 'description': 'traumatic and surgical wounds closed at the initial surgical intervention', 'armGroupLabels': ['immediate wound closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Michael J Bosse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolians HealthCare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}, {'name': 'Orthopaedic Research and Education Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}