Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-09 @ 2:44 AM
Study NCT ID:
NCT03391960
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2017-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Passive Disinfection Cap Compliance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhan3@mmm.com', 'phone': '651-737-9234', 'title': 'Helen Han', 'organization': '3M'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The rate of CLABSI per 1000 central line days was determined by using aggregated data on infections and on CVC/day during the study period. Infections from patients without CVC IV access were also part of the aggregated data recorded. However, as these patients did not have CVC access, they did not contribute to the CVC/day data collected throughout the study. As a result, the rate of CLABSI may have been overestimated.'}}, 'adverseEventsModule': {'timeFrame': 'No individual patient data (including adverse events [AEs]) were recorded during this study.', 'description': 'No individual patient data (including adverse events \\[AEs\\]) were recorded during this study as no individual patient was enrolled into the study .', 'eventGroups': [{'id': 'EG000', 'description': 'No individual patient data (including adverse events \\[AEs\\]) were recorded during this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disinfecting Barrier Cap Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Compliance audits', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Disinfecting Barrier Cap Compliance', 'description': 'In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines.\n\nCompliance with disinfecting barrier cap was observed weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.43', 'spread': '4.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month prospective period', 'description': 'Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.', 'unitOfMeasure': 'percentage of connector with compliance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Compliance audits', 'denomUnitsSelected': 'Compliance audits', 'populationDescription': 'No patients assessed for disinfecting barrier cap compliance. Compliance with disinfecting barrier cap was measured by observation of numbers of applicable capped, uncapped ports and misused caps. A total of 156 audits were performed.'}, {'type': 'PRIMARY', 'title': 'Scrub the Hub Protocol Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Scrub the Hub Protocol Compliance', 'description': "Compliance with Scrub the hub protocol\n\nData collected by survey\n\nNo individual patient's information was collected during the study"}], 'classes': [{'categories': [{'measurements': [{'value': '5.95', 'spread': '21.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month retrospective period', 'description': 'Compliance with Scrub the hub protocol\n\nData collected retrospectively by survey', 'unitOfMeasure': 'percentage of protocol compliance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Compliance with scrub the hub was retrospectively obtained by a survey from 165 healthcare workers who were using needlessness connectors for patient IV access. One was excluded from the compliance analysis due to an inconsistency in the survey data. No patients assessed for disinfecting barrier cap compliance.'}, {'type': 'SECONDARY', 'title': 'CLABSI Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'ICU and non-ICU wards', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLABSI Rate for Pre-intervention Period', 'description': 'Number of CLABSI infections and CVC/day recorded during 6 pre-intervention months were used to determine the rate of CLABSI during the 6-month pre-intervention period.'}, {'id': 'OG001', 'title': 'CLABSI Rate for Post-intervention Period', 'description': 'Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access', 'unitOfMeasure': 'CLABSI rate per 1000 catheter days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ICU and non-ICU wards', 'denomUnitsSelected': 'ICU and non-ICU wards', 'populationDescription': 'Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.'}, {'type': 'SECONDARY', 'title': 'Catheter-associated Urinary Tract Infection (CAUTI) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Units in ICU ward', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAUTI Rate 6 Months Pre-intervention', 'description': 'CAUTI rate per 1000 catheter/days during 6 months pre-intervention'}, {'id': 'OG001', 'title': 'CAUTI Rate 6 Months Post-intervention', 'description': 'CAUTI rate per 1000 catheter/days during 6 months post intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}, {'value': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months pre-intervention and 6 months post intervention', 'description': 'Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil.', 'unitOfMeasure': 'CAUTI rate per 1000 catheter days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Units in ICU ward', 'denomUnitsSelected': 'Units in ICU ward', 'populationDescription': 'Infections from patients with indwelling urinary catheters in one ICU ward. Total 6 units. No individual patients were enrolled in this study. No patients assessed for this measure.'}, {'type': 'SECONDARY', 'title': 'Ventilator-associated Pneumonia (VAP) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Units in ICU ward', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VAP Rate Pre-intervention', 'description': 'VAP rate per 1000 ventilator days 6 months pre-intervention'}, {'id': 'OG001', 'title': 'VAP Rate Post Intervention', 'description': 'VAP rate per 1000 ventilator days 6 months post-intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil.', 'unitOfMeasure': 'VAP rate per 1000 ventilator days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Units in ICU ward', 'denomUnitsSelected': 'Units in ICU ward', 'populationDescription': 'Infections from patients who have been intubated and received mechanical ventilation in one ICU ward (6 units). No Patients assessed for this measure.'}, {'type': 'SECONDARY', 'title': 'MBI-Related CLABSI Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'ICU and non-ICU wards', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBI-related CLABSI Rate for Pre-intervention Period', 'description': 'Number of MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of MBI CLABSI during the pre-intervention period.'}, {'id': 'OG001', 'title': 'MBI-related CLABSI Rate for Prospective Period', 'description': 'Number of MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of MBI CLABSI during the prospective period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.', 'unitOfMeasure': 'MBI CLABSI rate per 1000 catheter days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ICU and non-ICU wards', 'denomUnitsSelected': 'ICU and non-ICU wards', 'populationDescription': 'Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.'}, {'type': 'SECONDARY', 'title': 'Non MBI-related CLABSI Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'ICU and non-ICU wards', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-MBI CLABSI Rate for Pre-intervention Period', 'description': 'Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of CLABSI during the pre-intervention period'}, {'id': 'OG001', 'title': 'Non-MBI CLABSI Rate for Prospective Period', 'description': 'Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of CLABSI during the prospective period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000'}, {'value': '1.92', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.', 'unitOfMeasure': 'CLABSI rate per 1000 catheter days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ICU and non-ICU wards', 'denomUnitsSelected': 'ICU and non-ICU wards', 'populationDescription': 'Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Compliance With Scrub the Hub Protocol', 'description': 'Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector'}, {'id': 'FG001', 'title': 'Compliance With Disinfecting Barrier Cap Ptotocol', 'description': 'In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines.\n\nCompliance with disinfecting barrier cap was observed weekly.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Units were not assessed for this Arm/Group. Data was collected from the health care worker surveys for the retrospective study to monitor compliance with the scrub-the-hub protocol (signed informed consent and were enrolled)', 'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '165'}, {'comment': 'No individual patient was recruited into the study. Data was collected from the compliance audits to monitor compliance with the disinfecting barrier cap protocol.', 'groupId': 'FG001', 'numUnits': '156', 'numSubjects': 'NA'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '165'}, {'comment': 'No individual patient was recruited into the study. Data was collected from the compliance audits to monitor compliance with the disinfecting barrier cap protocol.', 'groupId': 'FG001', 'numUnits': '156', 'numSubjects': 'NA'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': 'NA'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': 'NA'}]}]}], 'typeUnitsAnalyzed': 'Compliance audits', 'recruitmentDetails': 'No individual patient was recruited into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Not Applicable', 'description': 'During the study, Baseline data were not collected for the health care workers. No individual patient was consented in the study.'}], 'measures': [{'title': 'Age, Customized', 'description': 'Not Available. Baseline data were not collected for the health care workers.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'description': 'Measure Description: Not Available. Baseline data were not collected for the health care workers.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}], 'description': 'Measure Description: Not Available. Baseline data were not collected for the health care workers.'}, {'title': 'Study-Specific Measure', 'description': 'Measure Description: Not Available. Baseline data were not collected for the health care workers.'}], 'populationDescription': 'Baseline data were not collected for the health care workers. No individual patient was consented in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-28', 'size': 485149, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-22T16:19', 'hasProtocol': True}, {'date': '2019-07-24', 'size': 409389, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-22T16:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2017-12-07', 'resultsFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-14', 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disinfecting Barrier Cap Compliance', 'timeFrame': '6-month prospective period', 'description': 'Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.'}, {'measure': 'Scrub the Hub Protocol Compliance', 'timeFrame': '6-month retrospective period', 'description': 'Compliance with Scrub the hub protocol\n\nData collected retrospectively by survey'}], 'secondaryOutcomes': [{'measure': 'CLABSI Rate', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access'}, {'measure': 'Catheter-associated Urinary Tract Infection (CAUTI) Rate', 'timeFrame': '6 months pre-intervention and 6 months post intervention', 'description': 'Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil.'}, {'measure': 'Ventilator-associated Pneumonia (VAP) Rate', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil.'}, {'measure': 'MBI-Related CLABSI Rate', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.'}, {'measure': 'Non MBI-related CLABSI Rate', 'timeFrame': '6-month retrospective period and 6-month prospective period', 'description': 'Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days.\n\nInfections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CLABSI', 'Septicemia', 'Bloodstream infection', 'Central line associated bloodstream infection', 'Catheter related bloodstream infection', 'Intravascular device', 'Catheter port'], 'conditions': ['Infection, Hospital']}, 'descriptionModule': {'briefSummary': 'Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.\n\nThe purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.\n\nThe compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.', 'detailedDescription': 'Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.\n\nThe purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.\n\nCompliance is defined as following the protocol for disinfection of the catheter port. In the pre-intervention period, the disinfection protocol will utilize existing institution scrub-the-hub method. Compliance in the pre-intervention period will be determined by survey.\n\nAfter the pre-intervention period is complete, passive disinfecting devices (caps) will be implemented hospital-wide for any adult patient using CVC ports.\n\nIn the intervention period, the disinfection protocol consists of using the disinfecting barrier cap on every needless connector (catheter port) used for accessing CVC IV lines per protocol. Compliance will be measured using observations, according to a schedule to ensure the absence of a shift bias. Observations will contain the number of needless connectors on CVCs with, and the number of needleless connectors without, disinfecting barrier caps attached.\n\nThe compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.\n\nIncidence of CLABSI will be noted from existing aggregate hospital surveillance system data. The incidence, in terms of catheter days, will be recorded for each assigned intervention ward and for intervention ward overall by month, in the six months before the intervention and in the six-month intervention recording period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted to the participant oncologic hospital\n* Adult patients in the assigned intervention units during the seven month intervention period who require needleless connectors for CVC IV tubing access.\n\nExclusion Criteria:\n\n* Adult patients admitted to the participant oncologic hospital during the seven month intervention period that do not require needleless connectors for CVC IV access during their hospital stay.'}, 'identificationModule': {'nctId': 'NCT03391960', 'briefTitle': 'Passive Disinfection Cap Compliance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'A Compliance Improvement Project to Reduce Central Line Associated Blood Stream Infection (CLABSI) Using a Passive Disinfection Device in an Adult Oncological Hospital in Brazil', 'orgStudyIdInfo': {'id': 'CLIN-PROT-ICH-US-05-319980'}, 'secondaryIdInfos': [{'id': 'Study 05-014137', 'type': 'OTHER', 'domain': '3M'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Disinfecting barrier cap', 'description': 'In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines.\n\nCompliance with disinfecting barrier cap was observed weekly.', 'interventionNames': ['Device: Passive disinfection device']}], 'interventions': [{'name': 'Passive disinfection device', 'type': 'DEVICE', 'otherNames': ['Passive disinfecting cap', 'Disinfecting cap', 'Curos disinfecting cap', 'Curos cap'], 'description': 'Add use of passive disinfection cap to existing central line needleless connector infection control procedure', 'armGroupLabels': ['Disinfecting barrier cap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55144', 'city': 'Maplewood', 'state': 'Minnesota', 'country': 'United States', 'facility': '3M HealthCare', 'geoPoint': {'lat': 44.95302, 'lon': -92.99522}}], 'overallOfficials': [{'name': 'Ricardo A Zimerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be recorded in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurotrials Brasil Consultores Cientificos Ltda', 'class': 'INDUSTRY'}, {'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}