Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-03-02 @ 10:34 PM
Study NCT ID:
NCT01262105
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Device to Reduce Surgery Site Contamination - Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'self@nimbicsystems.com', 'phone': '281-565-5700', 'title': 'Sean Self', 'organization': 'Nimbic Systems'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Device', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Device Deployed', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgery Site CFU Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device', 'description': 'No device is deployed during surgery'}, {'id': 'OG001', 'title': 'Device Deployed', 'description': 'The ABS device is employed during surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000', 'lowerLimit': '2.44', 'upperLimit': '3.72'}, {'value': '1.73', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '2.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Ten-minute intervals throughout procedure', 'description': 'CFU culture counts for samples taken in surgery.', 'unitOfMeasure': 'CFU/m3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Device'}, {'id': 'FG001', 'title': 'Device Deployed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Device'}, {'id': 'BG001', 'title': 'Device Deployed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-09', 'studyFirstSubmitDate': '2010-12-15', 'resultsFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2010-12-15', 'lastUpdatePostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-14', 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery Site CFU Density', 'timeFrame': 'Ten-minute intervals throughout procedure', 'description': 'CFU culture counts for samples taken in surgery.'}]}, 'conditionsModule': {'keywords': ['CFU', 'surgery site'], 'conditions': ['Surgery']}, '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': 'The 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 spinal procedures.', 'detailedDescription': 'The Air Barrier System 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 Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for instrumented posterior lumbar interbody fusion\n\nExclusion Criteria:\n\n* Prior history of infection\n* Revision surgery\n* Screens positive for MRSA'}, 'identificationModule': {'nctId': 'NCT01262105', 'briefTitle': 'Device to Reduce Surgery Site Contamination - Spine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nimbic Systems, LLC'}, 'officialTitle': 'Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow', 'orgStudyIdInfo': {'id': 'ABS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No device'}, {'type': 'EXPERIMENTAL', 'label': 'Device deployed', 'interventionNames': ['Device: Air Barrier System Device']}], 'interventions': [{'name': 'Air Barrier System Device', 'type': 'DEVICE', 'description': 'Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.', 'armGroupLabels': ['Device deployed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Orthopedic Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Wimberley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondren Orthopaedic Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nimbic Systems, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}