Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-02 @ 10:40 AM
Study NCT ID:
NCT04666532
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-08', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S. aureus Culture and Next Generation Sequencing', 'timeFrame': '1 day', 'description': 'Diagnostic performance of molecular and culture techniques for S. aureus screening using nasal and groin swabs to determine whether the S. aureus retrieved on the skin and nares of patients who develop a joint infection is identical to the bacteria found in the wound of the PJI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Staphylococcus Aureus']}, 'descriptionModule': {'briefSummary': "Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year.\n\nPatients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who are undergoing revision total knee or hip arthroplasty by one of the joints surgeons at Rothman Orthopaedics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible\n\nExclusion Criteria:\n\n* Patients included in other prospective studies'}, 'identificationModule': {'nctId': 'NCT04666532', 'briefTitle': 'S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Staphylococcus Aureus Translocation From Skin and Nose to Periprosthetic Tissues', 'orgStudyIdInfo': {'id': 'JPAR20D165 FARE'}}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}