Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT05972603
Status:
UNKNOWN
Last Update Posted:
2023-08-02
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periprosthetic joint infection', 'timeFrame': '90 days', 'description': 'infection rate in each group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip', 'Rheumatoid Arthritis', 'Avascular Necrosis of Hip']}, 'referencesModule': {'references': [{'pmid': '38987786', 'type': 'DERIVED', 'citation': 'Kulakowski M, Elster K, Szymczak M, Sleczka P, Baumgart M, Krolikowska A, Reichert P. Comparison of the effect of combined usage of povidone-iodine irrigation and topical vancomycin powder to the use of povidone-iodine irrigation alone on the periprosthetic joint infection incidence rate in patients undergoing primary total hip and knee arthroplasty: a protocol for multicenter prospective randomized clinical trial. Trials. 2024 Jul 10;25(1):468. doi: 10.1186/s13063-024-08306-3.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.', 'detailedDescription': 'Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.\n\nPatients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening\n\nExclusion Criteria:\n\n* Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty'}, 'identificationModule': {'nctId': 'NCT05972603', 'briefTitle': 'Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Independent Public Healthcare Center in Rypin'}, 'officialTitle': 'Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0,35% povidone-iodine solution lavage', 'description': '0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.', 'interventionNames': ['Procedure: 0,35% povidone-iodine solution lavage']}, {'type': 'EXPERIMENTAL', 'label': '1.0 g Vancomycin powder into the wound', 'description': 'additional 1.0 g Vancomycin powder into the wound', 'interventionNames': ['Procedure: 1.0 g Vancomycin powder into the wound']}], 'interventions': [{'name': '1.0 g Vancomycin powder into the wound', 'type': 'PROCEDURE', 'description': '0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound', 'armGroupLabels': ['1.0 g Vancomycin powder into the wound']}, {'name': '0,35% povidone-iodine solution lavage', 'type': 'PROCEDURE', 'description': '0,35% povidone-iodine solution lavage left for 3 minutes following final implantation', 'armGroupLabels': ['0,35% povidone-iodine solution lavage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87-500', 'city': 'Rypin', 'state': 'Kujawsko-pomorksie', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Karol Elster, Md Phd', 'role': 'CONTACT', 'email': 'karol.elster@gmail.com', 'phone': '+48662128773'}], 'facility': 'IPHC Rypin', 'geoPoint': {'lat': 53.06603, 'lon': 19.40941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Independent Public Healthcare Center in Rypin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}