Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 5:36 AM
Study NCT ID:
NCT01105195
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Surgical Preparations in Lumbar Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515331', 'term': 'DuraPrep'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-16', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive culture results', 'timeFrame': '7 days', 'description': 'Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DuraPrep', 'ChloraPrep', 'Lumbar Spine'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '19651954', 'type': 'BACKGROUND', 'citation': 'Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.'}, {'pmid': '15866959', 'type': 'BACKGROUND', 'citation': 'Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.'}], 'seeAlsoLinks': [{'url': 'http://www.chloraprep.com/', 'label': 'Information on ChloraPrep'}, {'url': 'http://www.3m.com/product/information/DuraPrep-Surgical-Solution.html', 'label': 'Information on DuraPrep'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).\n\nExclusion Criteria:\n\n* Open wound at the incision site,\n* Abrasion in the vicinity of the incision site,\n* An active infection at or near the surgical site, or\n* An active infection elsewhere in the body.'}, 'identificationModule': {'nctId': 'NCT01105195', 'briefTitle': 'Efficacy of Surgical Preparations in Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Efficacy of Surgical Preparations in Lumbar Spine Surgery', 'orgStudyIdInfo': {'id': 'STU00008875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DuraPrep', 'interventionNames': ['Other: DuraPrep']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ChloraPrep', 'interventionNames': ['Other: ChloraPrep']}], 'interventions': [{'name': 'DuraPrep', 'type': 'OTHER', 'description': 'DuraPrep is used for skin preparation prior to surgery.', 'armGroupLabels': ['DuraPrep']}, {'name': 'ChloraPrep', 'type': 'OTHER', 'description': 'ChloraPrep is used for skin preparation prior to surgery.', 'armGroupLabels': ['ChloraPrep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Michael Haak, MD', 'oldOrganization': 'Northwestern University Feinberg School of Medicine'}}}}