Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02324868
Status:
TERMINATED
Last Update Posted:
2016-03-30
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Availability of Showerpatch for Patients With Intravenous Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'logistic problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin irritation after application of Showerpatch', 'timeFrame': 'Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Redness or other sign of skin irritation at the place where adhesive of the new protection dressing had contact with the skin on a yes/no basis'}, {'measure': 'Catheter/Huber needle status', 'timeFrame': 'Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Expressed on a 3-point scale from 0 which means correct in place to 2 totally removed'}], 'primaryOutcomes': [{'measure': 'Self-reported autonomy score regarding bathing activities', 'timeFrame': 'Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis'}], 'secondaryOutcomes': [{'measure': 'Number and type of bathing activities', 'timeFrame': 'Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Number and type of bathing activities per week'}, {'measure': 'Catheter dressing status: wet', 'timeFrame': 'Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Expressed on a 3-point scale from 0 which means not wet to 2 totally wet'}, {'measure': 'Catheter dressing status: loose', 'timeFrame': 'Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Expressed on a 3-point scale from 0 which means not loose to 2 totally loose'}, {'measure': 'Time needed from a caregiver', 'timeFrame': 'Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Time expressed in minutes per week'}, {'measure': 'Material consumption regarding IV entry site care for bathing activities', 'timeFrame': 'Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Description of material which was used for catheter dressing protection and/or for the extra dressing change and/or extra securement of the dressing afterwards.'}, {'measure': 'Clinical signs of local infection', 'timeFrame': 'Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Redness, tenderness, warmth, swelling or pus leakage recorded on a yes/no basis'}, {'measure': 'Laboratory-Confirmed Bloodstream Infection', 'timeFrame': 'Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks', 'description': 'Collected at the end of the study by retrospective analysis of the patient file in case of hospital admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bandages', 'Catheter'], 'conditions': ['Cystic Fibrosis', 'Pulmonary Hypertension', 'Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21511081', 'type': 'BACKGROUND', 'citation': "O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available."}, {'pmid': '12849017', 'type': 'BACKGROUND', 'citation': 'Oakley C, Wright E, Ream E. The experiences of patients and nurses with a nurse-led peripherally inserted central venous catheter line service. Eur J Oncol Nurs. 2000 Dec;4(4):207-18. doi: 10.1054/ejon.2000.0099.'}, {'pmid': '18705719', 'type': 'BACKGROUND', 'citation': 'Molloy D, Smith LN, Aitchison T. Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC-line. J Clin Nurs. 2008 Sep;17(18):2398-407. doi: 10.1111/j.1365-2702.2008.02359.x.'}, {'pmid': '9878029', 'type': 'BACKGROUND', 'citation': 'Do AN, Ray BJ, Banerjee SN, Illian AF, Barnett BJ, Pham MH, Hendricks KA, Jarvis WR. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis. 1999 Feb;179(2):442-8. doi: 10.1086/314592.'}], 'seeAlsoLinks': [{'url': 'http://www.cdc.gov/nhsn/PDFs/pscManual/4PSC_CLABScurrent.pdf', 'label': 'Definition of Laboratory-Confirmed Bloodstream Infection (LCBI) infection'}]}, 'descriptionModule': {'briefSummary': "Venous catheters are necessary for the treatment of many patients. Showering with a venous catheter is often prohibited due to the infection risk when the insertion site becomes wet. Therefore these patients are challenged to keep the catheter insertion site dry and always covered with a dressing. Washing themselves is often impossible without assistance of a nurse or significant other. For patients with a catheter connected to an infusion line, it is even more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site of an IV catheter from water during bathing activities. The purpose of this trial is to evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients regarding the patient's autonomy in bathing activities, the material use and the time needed from caregivers in home care. Additionally qualitative data on patient's bathing activities and the use of Showerpatch will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to read and speak Dutch and to fill out a web-based questionnaire\n* patients with an IV catheter (peripheral catheter, midline, peripherally inserted central catheter (PICC), Central Venous catheter (CVC), tunnelled catheter or implantable port) with an expected dwell time IV therapy of at least 14 days and with or without a prospect of discharge to the home setting with the IV catheter in situ in the foreseen study period\n* physically able to wash themselves\n* with access to the internet\n\nExclusion Criteria:\n\n* Bedridden patients\n* Patients who have already participated in an earlier stage of the ISIC study\n* Patients with more than one lumen of the catheter continuously connected to an infusion line'}, 'identificationModule': {'nctId': 'NCT02324868', 'acronym': 'ISIC', 'briefTitle': 'Impact of Availability of Showerpatch for Patients With Intravenous Catheters', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities', 'orgStudyIdInfo': {'id': 'S57372'}, 'secondaryIdInfos': [{'id': 'FC13145773', 'type': 'OTHER_GRANT', 'domain': "Flander's care"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shower patch IV catheter protection', 'description': 'Newly developed waterproof catheter dressing may be used for bathing activities', 'interventionNames': ['Device: Shower patch IV catheter protection']}, {'type': 'OTHER', 'label': 'Conventional IV catheter protection', 'description': 'No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities.', 'interventionNames': ['Device: Conventional IV catheter protection']}], 'interventions': [{'name': 'Shower patch IV catheter protection', 'type': 'DEVICE', 'description': 'Shower patch will be available for the patient for bathing activities', 'armGroupLabels': ['Shower patch IV catheter protection']}, {'name': 'Conventional IV catheter protection', 'type': 'DEVICE', 'description': 'No Shower patch will be provided during study period', 'armGroupLabels': ['Conventional IV catheter protection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Godelieve A Goossens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'BEDAL', 'class': 'UNKNOWN'}, {'name': 'Remedus', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}