Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01112020
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Components of Chlorhexidine Gluconate Dressing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chlorhexidine gluconate (CHG) level', 'timeFrame': '1 week', 'description': 'CHG level in dressing after 7 days exposure to CHG-containing test articles'}], 'secondaryOutcomes': [{'measure': 'Parachloroaniline (PCA) level', 'timeFrame': '7 days', 'description': 'PCA level in dressing after 7 days exposure to CHG-containing test articles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chlorhexidine digluconate (CHG)', 'Biopatch Protective Disk', 'Tegaderm CHG IV (intravenous) Securement Dressing', 'parachloroaniline (PCA)', 'No condition being studied.', 'Assessing components of CHG-containing dressings after use.'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.', 'detailedDescription': 'To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read, review and sign the Informed Consent\n* Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study\n* Use study-approved contraceptive methods\n\nExclusion Criteria:\n\n* Participation in an investigational study within 28 days prior to dosing.\n* Clinically significant illness within 28 days prior to dosing.\n* History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex\n* History of clinically significant skin disorders\n* History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)\n* History of significant dermatologic cancers (melanoma, squamous)\n* Known history of immunologic disorders\n* Use immunosuppressive or other proscribed medications\n* Use of skin products at the application site\n* Significant history of allergies to soaps, lotions, emollients, ointments, creams\n* History of drug or alcohol addiction within the past year\n* Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study'}, 'identificationModule': {'nctId': 'NCT01112020', 'briefTitle': 'Components of Chlorhexidine Gluconate Dressing', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period', 'orgStudyIdInfo': {'id': 'S10-0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHG Catheter Dressing Patch', 'interventionNames': ['Device: CHG Catheter Dressing Patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biopatch', 'description': 'Biopatch Protective Disk with CHG', 'interventionNames': ['Device: Biopatch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tegaderm CHG', 'description': 'Tegaderm CHG IV Securement Dressing', 'interventionNames': ['Device: Tegaderm CHG']}], 'interventions': [{'name': 'CHG Catheter Dressing Patch', 'type': 'DEVICE', 'description': '2% CHG dressing applied to 7 sites', 'armGroupLabels': ['CHG Catheter Dressing Patch']}, {'name': 'Biopatch', 'type': 'DEVICE', 'description': 'Biopatch applied to 7 sites', 'armGroupLabels': ['Biopatch']}, {'name': 'Tegaderm CHG', 'type': 'DEVICE', 'description': 'Tegaderm CHG IV Securement Dressing applied to 7 sites', 'armGroupLabels': ['Tegaderm CHG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}], 'overallOfficials': [{'name': 'Ramon Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cetero Research, San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}