Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-03-30 @ 11:22 PM
Study NCT ID:
NCT01264003
Status:
COMPLETED
Last Update Posted:
2010-12-21
First Post:
2010-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-20', 'studyFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Drug side effects', 'timeFrame': '5 days postoperatively'}, {'measure': '1-year prosthetic repair surgical site late infection rate', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia, antibiotic, prophylaxis'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.', 'detailedDescription': 'There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: inguinal hernia repair -\n\nExclusion Criteria: uncontrolled diabetes mellitus,\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01264003', 'briefTitle': 'Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias', 'orgStudyIdInfo': {'id': 'DEAH-1002-IHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Antibiotic prohylaxis / Lichtenstein repair', 'interventionNames': ['Drug: sefazolin']}], 'interventions': [{'name': 'sefazolin', 'type': 'DRUG', 'description': 'In prophylaxis', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': '4.Cerrahi Kliniği', 'oldOrganization': 'Diskapi Teaching and Research Hospital'}}}}