Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03473405
Status:
UNKNOWN
Last Update Posted:
2018-12-13
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the number of colony-forming units captured at incision sites', 'timeFrame': 'Four months', 'description': 'A length of tubing will be placed at the incision and will draw air onto agar plates that are changed every ten minutes in both the control and ABS arms.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total knee replacement', 'Operating room airborne CFU'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '19913327', 'type': 'BACKGROUND', 'citation': "Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12."}]}, 'descriptionModule': {'briefSummary': 'This objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.', 'detailedDescription': 'The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU at the surgery site during total knee arthroplasty surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for total knee arthroplasty\n\nExclusion Criteria:\n\n* Prior history of infection\n* Revision surgery\n* Screens positive for MRSA'}, 'identificationModule': {'nctId': 'NCT03473405', 'briefTitle': 'Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nimbic Systems, LLC'}, 'officialTitle': 'Air Barrier System for the Reduction of Airborne Particulate and Colony Forming Units (CFU) During Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'ABS-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device is turned on or not.', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Air Barrier System', 'description': 'In the experimental (intervention) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not.', 'interventionNames': ['Device: Air Barrier System']}], 'interventions': [{'name': 'Air Barrier System', 'type': 'DEVICE', 'description': 'The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.', 'armGroupLabels': ['Air Barrier System']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gregory Stocks, MD', 'role': 'CONTACT', 'email': 'stocks@fondren.com', 'phone': '713-799-8600'}, {'name': 'Sean Self', 'role': 'CONTACT', 'email': 'self@nimbicsystems.com', 'phone': '281-565-5715'}], 'overallOfficials': [{'name': 'Gregory Stocks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Orthopedic Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nimbic Systems, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Texas Orthopedic Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}