Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT00530400
Status:
COMPLETED
Last Update Posted:
2007-09-17
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002444', 'term': 'Cefuroxime'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2000-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-14', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a surgical site infection', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of a post-operative infection other than surgical site infection', 'timeFrame': '6 monts'}, {'measure': 'Serious adverse event', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antibiotic prophylaxis', 'Bacterial Infections / prevention & control', 'Surgical wound infection / prevention & control', 'Neurosurgery', 'Postoperative Complications / prevention & control', 'Clinical trial [publication type]'], 'conditions': ['Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18\n* spinal surgery for herniated disk\n\nExclusion Criteria:\n\n* known or suspected hypersensitivity to cephalosporins\n* type I hypersensitivity to betalactamic antibiotics\n* severe renal function impairment\n* acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression\n* antibiotic therapy for concomitant infection at the time of surgery\n* pregnancy\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT00530400', 'briefTitle': 'Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery', 'orgStudyIdInfo': {'id': 'CFX93LS06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'intravenous 1.5g cefuroxime', 'interventionNames': ['Drug: cefuroxime']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'intravenous placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'cefuroxime', 'type': 'DRUG', 'description': 'preoperative intravenous 1.5g cefuroxime', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'preoperative intravenous placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaire de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Patrick Francioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}]}}}