Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT06601803
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-09-19
First Post:
2024-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgiphor Us in TSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction or elimination of bacteria', 'timeFrame': '90 days', 'description': 'To determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty participants will be followed to watch for clinical signs of infection.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Shoulder Arthroplasty', 'Shoulder Infection', 'Povidone Iodine']}, 'descriptionModule': {'briefSummary': 'Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane.\n\nThis study examines the use of Povidone-Iodine during primary shoulder arthroplasty.', 'detailedDescription': 'The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age \\>18 years\n* Participants undergoing elective primary total shoulder arthroplasty\n* Participants willing to provide written consent\n\nExclusion Criteria:\n\n* History of prior surgery to the operative shoulder\n* Known allergy to povidone iodine, iodine or shellfish\n* active clinical infection\n* participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT06601803', 'briefTitle': 'Surgiphor Us in TSA', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Effect of Surgiphor (sterile Povidone-Iodine) Wound Irrigation on Rate of Positive Deep Culture and NGS in Primary Total Shoulder Arthroplasty- a Prospective, Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'SNAM20D1057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Shoulder Arthroplasty washed with Saline', 'description': 'This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components', 'interventionNames': ['Drug: sterile saline solution', 'Procedure: Sample Collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)', 'description': 'This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components', 'interventionNames': ['Drug: Surgiphor', 'Procedure: Sample Collection']}], 'interventions': [{'name': 'sterile saline solution', 'type': 'DRUG', 'description': 'The shoulder will be washed with normal sterile saline before and after placing the shoulder implant', 'armGroupLabels': ['Total Shoulder Arthroplasty washed with Saline']}, {'name': 'Surgiphor', 'type': 'DRUG', 'description': 'The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant', 'armGroupLabels': ['Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)']}, {'name': 'Sample Collection', 'type': 'PROCEDURE', 'description': 'During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure', 'armGroupLabels': ['Total Shoulder Arthroplasty washed with Saline', 'Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}