Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-26 @ 7:17 AM
Study NCT ID:
NCT00548132
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bcamins@dom.wustl.edu', 'phone': '3144548351', 'title': 'Bernard C. Camins, MD', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.', 'otherNumAtRisk': 534, 'otherNumAffected': 0, 'seriousNumAtRisk': 534, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorhexidine-impregnated Foam Dressing', 'otherNumAtRisk': 554, 'otherNumAffected': 0, 'seriousNumAtRisk': 554, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Standard of care'}, {'id': 'OG001', 'title': 'Chlorhexidine Impregnated Sponge', 'description': 'Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.74', 'groupId': 'OG000'}, {'value': '4.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.90', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.05', 'estimateComment': 'The standard of care is the numerator and the intervention group is the denominator', 'groupDescription': 'The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This was calculated based on the assumption that only 85% of eligible patients will consent to the study.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization', 'unitOfMeasure': 'BSIs /1000 catheter days', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.'}, {'type': 'SECONDARY', 'title': 'Clinical Sepsis Episodes/Per 1000 Catheter Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.', 'unitOfMeasure': 'sepsis episodes/1000 catheter days', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.'}, {'id': 'FG001', 'title': 'Chlorhexidine-impregnated Foam Dressing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '554'}]}, {'type': 'Consented to Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '554'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '554'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patients were recruited from two ICUs at BJH. The nurse was asked to page the research coordinators on patients who were scheduled to have a central venous catheter placed for IV access.', 'preAssignmentDetails': 'Patients or family member authorized to consent for the patient (if the patient was not competent to consent to the study) were approached by study personnel for inclusion into the study. Written informed consent was obtained for all subjects and randomization group was assigned in blocks of 4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'BG000'}, {'value': '554', 'groupId': 'BG001'}, {'value': '1088', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.'}, {'id': 'BG001', 'title': 'Chlorhexidine-impregnated Foam Dressing', 'description': 'Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.26', 'spread': '16.88', 'groupId': 'BG000'}, {'value': '58.70', 'spread': '16.83', 'groupId': 'BG001'}, {'value': '58.47', 'spread': '16.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at enrollment was collected for this measure', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '629', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '459', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '534', 'groupId': 'BG000'}, {'value': '554', 'groupId': 'BG001'}, {'value': '1088', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1088}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2007-10-22', 'resultsFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-12', 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms', 'timeFrame': '2 years', 'description': 'The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization'}], 'secondaryOutcomes': [{'measure': 'Clinical Sepsis Episodes/Per 1000 Catheter Days', 'timeFrame': '2 years', 'description': 'This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Catheter-related Bloodstream Infection']}, 'descriptionModule': {'briefSummary': 'We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.', 'detailedDescription': 'At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).\n\nExclusion Criteria:\n\n* patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.'}, 'identificationModule': {'nctId': 'NCT00548132', 'briefTitle': 'Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)', 'orgStudyIdInfo': {'id': '00424-0805-01 (BJH Foundation)'}, 'secondaryIdInfos': [{'id': 'WUSM HRPO# 05-1186'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Patients in this arm will continue to get routine care'}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine-impregnated foam dressing', 'description': "Patient's catheters were cleaned with chlorhexidine-alcohol solution at least weekly before application of the Biopatch. These were evaluated daily and if the dressing was bloody, soiled or damaged, the dressing and the Biopatch were replaced prior to the 7-day period.", 'interventionNames': ['Device: Chlorhexidine-impregnated foam dressing']}], 'interventions': [{'name': 'Chlorhexidine-impregnated foam dressing', 'type': 'DEVICE', 'otherNames': ['Biopatch Antimicrobial Dressing'], 'description': 'Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.', 'armGroupLabels': ['Chlorhexidine-impregnated foam dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes- Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Bernard C Camins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}