Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 10:22 PM
Study NCT ID:
NCT02027532
Status:
TERMINATED
Last Update Posted:
2018-07-11
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005596', 'term': 'Fractures, Closed'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'whyStopped': 'Could not complete study due to administrative challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of infection', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection', 'Closed Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.\n\nThe hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 years old and 85 years old\n* Closed fracture\n* Fracture treatment plan is for one operation on one day (one surgical setting)\n* Likely to follow-up with surgeon until fracture is healed\n* Ability to understand and agree to Informed Consent\n\nExclusion Criteria:\n\n* Under 18 years old or over 85 years old\n* Open fracture(s)\n* Fracture requires multiple operations\n* Other injuries requiring operations\n* Documented allergy to Cefazolin or Vancomycin\n* Previous history of Methicillin-resistant Staphylococcus aureus infection\n* Previous surgery on the injured extremity within 1 year\n* Use of antibiotics within 2 weeks before or after injury\n* Use of antibiotics within 2 weeks before surgery\n* Unlikely to follow-up until fracture is healed\n* Unable to understand and agree to Informed Consent'}, 'identificationModule': {'nctId': 'NCT02027532', 'briefTitle': 'Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin', 'nctIdAliases': ['NCT01029457'], 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin', 'orgStudyIdInfo': {'id': '09-060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin', 'description': 'intravenous, weight-based dose (1gm\\<80kg, 2gm\\>80kg), perioperatively', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'intravenous, weight-based dose (1gm\\<80kg, 2gm\\>80kg), perioperatively', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'armGroupLabels': ['Cefazolin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Health System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}], 'overallOfficials': [{'name': 'Peter J Nowotarski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTCOM Chattanooga/Erlanger Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}