Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 5:31 PM
Study NCT ID:
NCT01583192
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2012-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062327', 'term': 'Skin Lightening Preparations'}], 'ancestors': [{'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of positive swab cultures', 'timeFrame': 'From start surgery week until 48 hours post-operatively', 'description': 'During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery.\n\nWe will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.'}, {'measure': 'wound infection', 'timeFrame': 'until 6 weeks postoperatively', 'description': 'we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively'}], 'secondaryOutcomes': [{'measure': 'Allergic events', 'timeFrame': 'Until 6 weeks postoperatively', 'description': 'we will look at the number of allergic events occuring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infection', 'skin preparation', 'fore-foot surgery', 'chloride-hexidine', 'povidine-jodine', 'alcohol'], 'conditions': ['Hallux Valgus', 'Arthritis of the First Metatarsophalangeal Joint']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.prezies.nl/zkh/definities/Definities_POWI_2012.pdf', 'label': 'woundinfection criteria'}]}, 'descriptionModule': {'briefSummary': 'The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.', 'detailedDescription': 'It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.\n\nThere will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18 years\n* written informed consent\n* indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint\n\nExclusion Criteria:\n\n* allergic for jodine-povidine and/or chloride-hexidine\n* active infection\n* skin defect\n* blood clotting or coagulation disorder'}, 'identificationModule': {'nctId': 'NCT01583192', 'briefTitle': 'Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery', 'orgStudyIdInfo': {'id': 'mbshadid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'chloride-hexidine soluted in alcohol', 'description': 'patients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery.\n\nSkin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation', 'interventionNames': ['Procedure: skin preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'povidine-jodine soluted in alcohol', 'description': 'skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.', 'interventionNames': ['Procedure: skin preparation']}], 'interventions': [{'name': 'skin preparation', 'type': 'PROCEDURE', 'description': 'skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%', 'armGroupLabels': ['chloride-hexidine soluted in alcohol', 'povidine-jodine soluted in alcohol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '340 EM', 'city': 'Nieuwegein', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'St Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Mario Speth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mario Speth', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}