Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02472158
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter Colonization', 'timeFrame': 'Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.', 'description': 'With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Catheter Colonization a significant growth of one or more microorganism in a semiquantitative culture of the catheter tip. It is according to the Clinical Practice Guidelines for the Diagnosis and management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases Society of America'}], 'secondaryOutcomes': [{'measure': 'Microbiological Exit site Infection', 'timeFrame': 'Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks', 'description': 'With aseptic technique, a swab will be collected before removal of central venous catheter, the swab will be moistened with sterile saline and rolled for about 2 cm around the exit site. The material will be conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Microbiological Exit Site Infection the exudate at catheter exit site yields a microorganism. According to Clinical Practice Guideline for Diagnosis and Management of intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America'}, {'measure': 'Clinical Exit Site Infection', 'timeFrame': 'Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks', 'description': 'Erythema, induration, and/or tenderness within 2 cm of the catheter exit site, according to Clinical Practice Guidelines for the diagnosis and management of intravascular Catheter-Related Infection: 2009 Update by the infectious diseases Society of America.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bandages', 'Central Venous Catheters', 'Catheter-Related Infections'], 'conditions': ['Catheter-Related Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCritically ill patients hospitalized carrying a short-term central venous catheter\n\nExclusion Criteria:\n\n* Use of a central venous catheter with antimicrobial coating\n* Suspected or confirmed bacterial infection at randomization\n* Known allergic/hypersensitivity reaction to any compounds of the treatment\n* Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;'}, 'identificationModule': {'nctId': 'NCT02472158', 'acronym': 'CISDCT', 'briefTitle': 'Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CISD-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chlorhexidine-gel-impregnated dressing', 'description': 'Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter', 'interventionNames': ['Device: chlorhexidine-gel-impregnated dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polyurethane film dressing', 'description': 'Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.', 'interventionNames': ['Device: Polyurethane film dressing']}], 'interventions': [{'name': 'chlorhexidine-gel-impregnated dressing', 'type': 'DEVICE', 'otherNames': ['3M Tegaderm CHG IV securement dressing™'], 'description': 'Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter', 'armGroupLabels': ['chlorhexidine-gel-impregnated dressing']}, {'name': 'Polyurethane film dressing', 'type': 'DEVICE', 'otherNames': ['3M Tegaderm IV dressing™'], 'description': 'Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.', 'armGroupLabels': ['Polyurethane film dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Amanda Salles Margatho, PhD student', 'role': 'STUDY_CHAIR', 'affiliation': 'University of São Paulo at Ribeirão Preto College of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Amanda Salles Margatho', 'investigatorAffiliation': 'University of Sao Paulo'}}}}