Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-31 @ 8:38 PM
Study NCT ID:
NCT01676051
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2012-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Prep in Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-28', 'studyFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of positive cultures', 'timeFrame': 'after skin prep solution has dried'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Surgical Scrubbing', 'Disinfection']}, 'referencesModule': {'references': [{'pmid': '22437997', 'type': 'BACKGROUND', 'citation': 'Savage JW, Weatherford BM, Sugrue PA, Nolden MT, Liu JC, Song JK, Haak MH. Efficacy of surgical preparation solutions in lumbar spine surgery. J Bone Joint Surg Am. 2012 Mar 21;94(6):490-4. doi: 10.2106/JBJS.K.00471.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to identify the common bacterial flora on the hand and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation. The null hypothesis is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in pre-operative skin preparation in clean, elective hand surgery cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing clean, elective hand surgery without implants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the following procedures (carpal tunnel release, trigger finger release, cyst excision, 1st dorsal compartment release)\n\nExclusion Criteria:\n\n* prisoners\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT01676051', 'briefTitle': 'Surgical Prep in Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Efficacy of Surgical Preparation Solutions in Hand Surgery', 'orgStudyIdInfo': {'id': 'PRO12080340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chloraprep', 'interventionNames': ['Other: Skin culture']}, {'label': 'Duraprep', 'interventionNames': ['Other: Skin culture']}, {'label': 'Betadine only', 'interventionNames': ['Other: Skin culture']}], 'interventions': [{'name': 'Skin culture', 'type': 'OTHER', 'description': 'Culture swab used to culture skin adjacent to incision', 'armGroupLabels': ['Betadine only', 'Chloraprep', 'Duraprep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Montefiore Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'John Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'John Fowler', 'investigatorAffiliation': 'University of Pittsburgh'}}}}