Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05030220
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2021-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone Levels and Cutibacterium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-08-29', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum testosterone', 'timeFrame': 'At pre-operative clinic appointment, typically within 30 days prior to surgery'}, {'measure': 'Free testosterone', 'timeFrame': 'At pre-operative clinic appointment, typically within 30 days prior to surgery'}, {'measure': 'sex hormone binding globulin', 'timeFrame': 'At pre-operative clinic appointment, typically within 30 days prior to surgery'}, {'measure': 'Cutibacterium specimen value', 'timeFrame': 'Skin swab at pre-operative clinic appointment, typically within 30 days prior to surgery'}, {'measure': 'Cutibacterium specimen value', 'timeFrame': 'Skin swab immediately pre-operative'}, {'measure': 'Cutibacterium specimen value', 'timeFrame': 'Freshly incised dermis of surgical wound'}, {'measure': 'Preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty.', 'timeFrame': 'Up to 20 years after surgery'}, {'measure': 'Preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty', 'timeFrame': '21 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testosterone', 'Cutibacterium', 'Shoulder Arthroplasty'], 'conditions': ['Arthroplasty, Replacement, Shoulder']}, 'descriptionModule': {'briefSummary': 'Phase 1: In 51 patients undergoing shoulder arthroplasties, total serum testosterone, free testosterone and sex hormone binding globulin levels obtained in the clinic before surgery were correlated with the levels of Cutibacterium on the skin in clinic, in the operating room prior to surgery, and in the skin incision.\n\nPhase 2: The investigators wish to determine if preoperative serum testosterone levels are associated with risk for shoulder PJI (periprosthetic joint infection) in patients undergoing primary shoulder arthroplasty. Also to determine if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.', 'detailedDescription': "Phase 1: 51 patients having elective shoulder arthroplasty were offered the opportunity to participate, consented and enrolled in this prospective clinical cohort study.\n\nAt a preoperative clinic visit, basic demographic information was collected along with the patient's response to a question about taking supplemental testosterone. A swab of the unprepared skin over the area of the intended surgical incision was obtained and sent for culture. At this clinic visit, a sample of the patient's blood was also obtained and submitted to our clinical laboratory for the levels of total serum testosterone, sec hormone binding globulin (SHBG), and free testosterone.\n\nImmediately before surgery, another swab of the unprepared skin over the area of the intended surgical incision was once again obtained and sent for culture. After incision, a swab of the freshly incised dermis was obtained and sent for culture.\n\nAll 3 swabs that were obtained were observed for 21 days. The investigators analyzed the cultures to determine the presence and load of bacteria using a semiquantitative method, known as the Cutibacterium specimen value (SpCuV)\n\nPhase 2: This phase will also involve a onetime pre-operative testosterone serum test. If the subject consents to participate, this additional sample of blood will be collected for a testosterone serum test during the routine pre-operative blood draw that all patients have before a shoulder arthroplasty regardless of research participation. The investigators will include cultures such as skin swabs taken at pre-operative clinic appointments, skin swabs taken at the time of surgery, incision swabs taken at the time of surgery, and discarded tissue from surgery using our standard protocol for specimens. For this study's outcome measures, the investigators will record the culture results from those clinical specimens and compare them to the testosterone serum test. Some subjects may also be a part of a long term follow-up study and the follow-up data (self-reported outcome measures, etc.) from that study will be included for analysis for those patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase 1 and 2: Subjects will be adult patients who present to the UWMC Bone \\& Joint Center for pre-operative appointments for elective shoulder arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Phase 1 Inclusion Criteria:\n\n* Patients having elective shoulder arthroplasty\n\nPhase 1 Exclusion Criteria:\n\n* history of shoulder septic arthritis\n* antibiotic use within 3 months prior to surgery\n* recent treatment for acne\n* Lacked fluency in English\n\nPhase 2 Inclusion Criteria:\n\n* Patients having elective shoulder arthroplasty\n\nPhase 2 Exclusion Criteria:\n\n* Lacked fluency in English'}, 'identificationModule': {'nctId': 'NCT05030220', 'briefTitle': 'Testosterone Levels and Cutibacterium', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Association Between Serum Testosterone Levels and Cutibacterium Culture Positivity During Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'STUDY00009200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1', 'description': '51 subjects with serum levels of testosterone, free testosterone, and sex hormone binding globulin as well as the SpCuV from the cultures obtained in clinic, immediately pre-operative skin cultures, and incised wound cultures.'}, {'label': 'Phase 2', 'description': 'Subjects enrolled to help determine if preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty and if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Hsu, MD', 'role': 'CONTACT', 'email': 'jehsu@uw.edu'}, {'name': 'Anastasia Whitson, BS', 'role': 'CONTACT', 'email': 'whitsa@uw.edu'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Jason E Hsu, MD', 'role': 'CONTACT', 'email': 'jehsu@uw.edu', 'phone': '330-883-8829'}, {'name': 'Anastasia Whitson, BS', 'role': 'CONTACT', 'email': 'whitsa@uw.edu', 'phone': '206-755-7847'}], 'overallOfficials': [{'name': 'Jason E Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine', 'investigatorFullName': 'Jason Hsu', 'investigatorAffiliation': 'University of Washington'}}}}