Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 5:09 AM
Study NCT ID:
NCT05576194
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2022-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C012566', 'term': 'taurolidine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1417}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CIED infection', 'timeFrame': 'three months', 'description': 'cardiac implantable electronic device infection'}], 'secondaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'three months', 'description': 'death of any cause during the observation'}, {'measure': 'adverse events grade 3-5', 'timeFrame': 'three months', 'description': 'adverse events related to CIED, procedure or the atiseptic used'}, {'measure': 'all cause mortality', 'timeFrame': '36 months', 'description': 'death of any cause during all of the follow up period'}, {'measure': 'adverse events grade 3-5', 'timeFrame': '36 months', 'description': 'adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac implantable electronic device infection, taurolidine'], 'conditions': ['Cardiac Implantable Electronic Device Infection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Borov, S., Baldauf, B., Lau, E.W. et al. Salvage of infected cardiac implantable electronic device with taurolidine-a case report. Cardiothorac Surg 30, 7 (2022). https://doi.org/10.1186/s43057-022-00068-5'}, {'pmid': '35323629', 'type': 'BACKGROUND', 'citation': 'Giaccardi M, Baldauf B, Lau EW, Borov S, Bonnemeier H. Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old. J Cardiovasc Dev Dis. 2022 Mar 10;9(3):81. doi: 10.3390/jcdd9030081.'}, {'pmid': '35050228', 'type': 'BACKGROUND', 'citation': 'Weichsel J, Baldauf B, Bonnemeier H, Lau EW, Dittrich S, Cesnjevar R. Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine. J Cardiovasc Dev Dis. 2022 Jan 10;9(1):18. doi: 10.3390/jcdd9010018.'}, {'pmid': '37831737', 'type': 'DERIVED', 'citation': 'Borov S, Baldauf B, Henke J, Pavaci H, Perani A, Zrenner B, Dietl J, Mehilli J, Lau EW, Vonthein R, Bonnemeier H. Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection. Europace. 2023 Oct 5;25(10):euad306. doi: 10.1093/europace/euad306.'}]}, 'descriptionModule': {'briefSummary': 'From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively.\n\nBefore that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.', 'detailedDescription': "All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The intervention group consists of every consecutive patient eligible for any CIED related surgical procedure in the centre of the investigation from January 2020 through February 2022 onwards.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nCIED procedure, signs PIC\n\nExclusion Criteria:\n\nPIC not signed, minor'}, 'identificationModule': {'nctId': 'NCT05576194', 'briefTitle': 'Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control', 'orgStudyIdInfo': {'id': '19059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TauroPace irrigation group', 'description': 'every consecutive CIED placement, revision, extraction conducted with TauroPace', 'interventionNames': ['Device: TauroPace']}, {'label': 'antiseptic irrigation group', 'description': 'every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%', 'interventionNames': ['Device: TauroPace', 'Device: Hydrogen Peroxide', 'Drug: Taurolidine']}], 'interventions': [{'name': 'TauroPace', 'type': 'DEVICE', 'description': 'All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution containing Taurolidine (TauroPace™, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system since January 2019', 'armGroupLabels': ['TauroPace irrigation group', 'antiseptic irrigation group']}, {'name': 'Hydrogen Peroxide', 'type': 'DEVICE', 'description': "All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing 3% hydrogen peroxide (H2O2) during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2020", 'armGroupLabels': ['antiseptic irrigation group']}, {'name': 'Taurolidine', 'type': 'DRUG', 'description': "All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing taurolidine in a galenic formulation during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2019", 'armGroupLabels': ['antiseptic irrigation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84036', 'city': 'Landshut', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Lakumed', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}], 'overallOfficials': [{'name': 'Stefan Borov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lakumed Landshut, CAU Kiel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Hendrik Bonnemeier', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Luebeck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Coordinating principal investigator', 'investigatorFullName': 'Prof. Dr. Hendrik Bonnemeier', 'investigatorAffiliation': 'University of Kiel'}}}}