Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT04822467
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2021-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SQ53 Disinfectant Wipes for Prevention of CRBSI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kirbyd@ccf.org', 'phone': '216-444-0446', 'title': 'Dr. Donald Kirby, MD', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Subject reported events', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use\n\nEthanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.\n\nSQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use\n\nEthanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change'}, {'id': 'OG001', 'title': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.\n\nSQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change'}], 'classes': [{'title': 'Intention to Treat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '3.34'}, {'value': '2.09', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '3.59'}]}]}, {'title': 'Met Protocol Compliance Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '3.13'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '2.28'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)', 'unitOfMeasure': 'Infections per 1000 days with catheter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was done on all subjects enrolled as well as those that met the protocol defined compliance rates.\n\nSubjects were removed due inability to continue with the protocol (moving to different Home Parenteral Nutrition service or not following treatment guidelines)'}, {'type': 'SECONDARY', 'title': 'Catheter Exchange Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use\n\nEthanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change'}, {'id': 'OG001', 'title': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.\n\nSQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change'}], 'classes': [{'title': 'Intention to Treat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '2.62'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '2.98'}]}]}, {'title': 'Met Protocol Compliance Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '2.52'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '1.82'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Reduction in catheter exchange rates by participants over 1000 days', 'unitOfMeasure': 'Exchanges per 1000 days with Catheter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was done on all subjects enrolled as well as those that met the protocol defined compliance rates.\n\nSubjects were removed due inability to continue with the protocol (moving to different Home Parenteral Nutrition service or not following treatment guidelines)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use\n\nEthanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change'}, {'id': 'FG001', 'title': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.\n\nSQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use\n\nEthanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change'}, {'id': 'BG001', 'title': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.\n\nSQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '15', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-27', 'size': 7157373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-20T15:34', 'hasProtocol': True}, {'date': '2021-09-21', 'size': 5135086, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-20T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2021-03-26', 'resultsFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-05', 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months', 'timeFrame': '6 months', 'description': 'Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)'}], 'secondaryOutcomes': [{'measure': 'Catheter Exchange Rates', 'timeFrame': '6 months', 'description': 'Reduction in catheter exchange rates by participants over 1000 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Catheter-related Bloodstream Infection']}, 'descriptionModule': {'briefSummary': 'SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Extensive laboratory testing has demonstrated the effectiveness of SQ53 impregnated wipes in cleaning surfaces including catheters over a 24 hour plus time period. SQ53 also received an in vitro evaluation of the irritancy potential using a tissue engineered human skin model and was found to have no potential for skin irritation. SQ53 is available as a sterilized pack with a single wipe inside. The pack is easy to open by tearing off the top end and presenting the contents to the operator to remove under sterile conditions.\n\nThe current study will be a randomized single-blinded placebo-controlled clinical trial for SQ53 wipes intended for catheter cleaning in patients receiving home parenteral nutrition.', 'detailedDescription': "Parenteral nutrition (PN) therapy is an essential component of medical management of patients suffering from intestinal failure. Depending on the underlying etiology and the type of intestinal failure, the duration of parenteral nutrition therapy could range from several weeks to several years, although a substantial proportion of these patients also require lifelong parenteral nutrition support. These patients continue the infusion of PN at their homes and are managed by the Cleveland Clinic's Home PN support team. These patients require Central Venous Catheters (CVC) for prolonged period of time for infusion of parenteral nutrition. The two most commonly used central catheters for TPN infusion are the Peripherally Inserted Central Catheter (PICC) and Tunneled CVCs. Catheter related blood stream infection (CRBSI) is a major complication of long-term CVCs. CRBSI is associated with high morbidity, mortality and healthcare cost. Additionally, CRBSI can also lead to an interruption in nutrient delivery, loss of work and productivity, premature vascular access device removal, and poor quality of life.\n\nPrevention of CRBSI is an important component of clinical management of patients receiving home PN therapy. Several strategies have been adopted to reduce the incidence of CRBSI. A heparin lock solution was used in the past for many years; however, current nutrition society guidelines recommend normal saline locks instead of heparin locks. Published data has suggested that heparin locks have not proven to have a substantial effect on CRBSI prevention, and it paradoxically increases the infection risk due to biofilm production. Antibiotic locks have also been used, although this practice is largely not preferred due to increased risk of infections with resistant microorganisms. Taurolidine is another lock solution which has been studied in the countries outside the United States such as Canada; however, it has not been approved for the use in the U.S. yet.1"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Women known to be pregnant\n* Women of childbearing age who are planning a pregnancy\n* Women who are breastfeeding\n* Patients who will not be managed by Cleveland Clinic HPN service\n* Patients who refuse to use disinfectant wipes daily.'}, 'identificationModule': {'nctId': 'NCT04822467', 'briefTitle': 'SQ53 Disinfectant Wipes for Prevention of CRBSI', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'SQ53 Disinfectant Wipes for Prevention of Catheter Related Blood Stream Infection in Patients Receiving Home Parenteral Nutrition: A Single Blind Randomized Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CC-SQ53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Wipe', 'description': 'Participants will receive a supply of ethanol-based wipes for daily use', 'interventionNames': ['Device: Ethanol Wipe']}, {'type': 'EXPERIMENTAL', 'label': 'SQ53 Wipe', 'description': 'Participants will receive a supply of SQ53 wipes for daily use.', 'interventionNames': ['Device: SQ53 Wipe']}], 'interventions': [{'name': 'SQ53 Wipe', 'type': 'DEVICE', 'description': 'SQ53-based wipe to be used by the participant daily or upon dressing change', 'armGroupLabels': ['SQ53 Wipe']}, {'name': 'Ethanol Wipe', 'type': 'DEVICE', 'description': 'Ethanol-based wipe to be used by the participant daily or upon dressing change', 'armGroupLabels': ['Standard Wipe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Donald Kirby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'JVS Products, Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Donald Kirby', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}