Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00896402
Status:
WITHDRAWN
Last Update Posted:
2015-08-27
First Post:
2009-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding inadequate', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2009-05-07', 'studyFirstSubmitQcDate': '2009-05-08', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application', 'timeFrame': 'July 2013'}], 'secondaryOutcomes': [{'measure': 'Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface', 'timeFrame': 'July 2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chloraprep', 'betadine', 'colonization', 'femoral catheter'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.\n\nThe American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.', 'detailedDescription': 'After antisepsis four different cultures will be analyzed:\n\n1. The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.\n2. immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.\n3. immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.\n4. just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3,\n* Undergoing primary total knee arthroplasty.\n\nExclusion Criteria:\n\n* Hypersensitivity/allergy to antiseptics,\n* Recent opioid/alcohol abuse,\n* Presence of contraindications to regional anesthesia,\n* Coagulation disorder,\n* Diabetic/femoral neuropathy,\n* Prior surgery to inguinal area,\n* Patient refusal.'}, 'identificationModule': {'nctId': 'NCT00896402', 'briefTitle': 'Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty', 'orgStudyIdInfo': {'id': '1989mdmd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine', 'description': 'skin antisepsis with chlorhexidine', 'interventionNames': ['Drug: Skin antisepsis with chlorhexidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone-iodine', 'description': 'skin antisepsis with povidone-iodine', 'interventionNames': ['Drug: povidone-iodine']}], 'interventions': [{'name': 'Skin antisepsis with chlorhexidine', 'type': 'DRUG', 'otherNames': ['Chlora-prep: 2% w/v chlorhexidine and 70% v/v isopropyl alcohol'], 'description': 'Chlorhexidine swabs will be used to antiseptically clean the skin, then cultures of the skin and femoral nerve block catheters will be analyzed via standard microbiological techniques', 'armGroupLabels': ['Chlorhexidine']}, {'name': 'povidone-iodine', 'type': 'DRUG', 'otherNames': ['Povidone-Iodine, USP 10% topical solution'], 'description': 'Povidone-iodine swabs will be used to antiseptically clean the skin; then cultures of the skin and femoral nerve catheters will be performed by standard microbiologic techniques', 'armGroupLabels': ['Povidone-iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11791', 'city': 'Syosset', 'state': 'New York', 'country': 'United States', 'facility': 'Syosset Hospital', 'geoPoint': {'lat': 40.82621, 'lon': -73.50207}}, {'zip': '11580', 'city': 'Valley Stream', 'state': 'New York', 'country': 'United States', 'facility': 'Franklin Hospital', 'geoPoint': {'lat': 40.66427, 'lon': -73.70846}}], 'overallOfficials': [{'name': 'Joseph Marino, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Franklin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Anesthesiology', 'investigatorFullName': 'Joseph Marino M.D.', 'investigatorAffiliation': 'Northwell Health'}}}}