Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT02272205
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concordance of pre-and intraoperative bacteriological documentation', 'timeFrame': 'preoperative; intraoperative', 'description': 'concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test'}], 'secondaryOutcomes': [{'measure': 'rates to relapse of the initial infection or a new infection', 'timeFrame': 'preoperative; intraoperative', 'description': 'rates to relapse of the initial infection or a new infection (survival curves according to Kaplan-Meier with log-rank test)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip replacement', 'Knee replacement', 'Knee infection', 'Hip infection', 'Antibiotic prophylaxis'], 'conditions': ['Total Hip Replacement']}, 'descriptionModule': {'briefSummary': 'Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.\n\nAntibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.\n\nExclusion Criteria:\n\n* patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.'}, 'identificationModule': {'nctId': 'NCT02272205', 'briefTitle': 'Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of the Effect of a Conventional Antibiotic Prophylaxis on the Positivity of Intraoperative Bacteriological Samples During a Change of Hip or Knee Infected at a Time', 'orgStudyIdInfo': {'id': '004-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrospective analysis of records', 'type': 'OTHER'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}