Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:41 PM
Study NCT ID:
NCT07406893
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of positive cultures', 'timeFrame': '14 days', 'description': 'Each participant will have culture swabs taken at the end of the surgical case from deep, superficial, and implant locations. Cultures will be held in the lab for 2 weeks to evaluate for the presence of bacteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Antimicrobial wound gel', 'Dermal layer', 'Skin preparation'], 'conditions': ['Joint Arthroplasty', 'Shoulder', 'Cutibacterium Acnes', 'Prosthetic Joint Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus Prontosan wound gel applied to the skin layer after the skin incision has been made.', 'detailedDescription': '60 male patients undergoing primary anatomic or reverse shoulder arthroplasty will be enrolled in this prospective, randomized controlled trial evaluating the use of Prontosan wound gel versus no preparation to the dermal layer of skin after incision has been made. Participants will be randomly assigned to one of two groups of 30 patients: control (no post-incision dermal preparation) and Prontosan antimicrobial gel application to the dermal layer after skin incision. All patients, regardless of assignment, receive the same pre-incision skin preparations, prophylactic antibiotics, and intraoperative irrigation. After final implantation and before wound closure, culture swabs will be obtained (2 deep cultures, 2 superficial, and 1 implant). All cultures will be held in the lab for 2 weeks to monitor for growth of C. acnes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male 18 years of age or older undergoing elective primary total shoulder arthroplasty, including both anatomic and reverse total shoulder arthroplasty, for indications including massive rotator cuffs, rotator cuff arthropathy, glenohumeral osteoarthritis, and acute fractures.\n\nExclusion Criteria:\n\n* Any revision shoulder arthroplasty procedure or other shoulder surgery that is not a primary shoulder arthroplasty.\n* Patients with allergy to active ingredients in Prontosan gel\n* Patient is unable to consent for themselves\n* Patient is non-English speaking\n* Females'}, 'identificationModule': {'nctId': 'NCT07406893', 'briefTitle': 'Reduction of Bacterial Seeding in Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients', 'orgStudyIdInfo': {'id': 'Study00000436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No skin incision preparation', 'description': 'All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with any additional agents for patients in this arm.'}, {'type': 'EXPERIMENTAL', 'label': 'Prontosan Wound Gel', 'description': 'All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will be prepped with Prontosan Wound Gel for patients in this arm. Prontosan Wound gel is an antimicrobial gel agent intended to keep wounds free of bacteria.', 'interventionNames': ['Device: Prontosan Wound Gel']}], 'interventions': [{'name': 'Prontosan Wound Gel', 'type': 'DEVICE', 'description': 'Applied to dermal layer of skin after incision is made for surgery.', 'armGroupLabels': ['Prontosan Wound Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Randall Otto, MD', 'role': 'CONTACT', 'phone': '314-617-2970'}, {'name': 'Allison Gruender, RN, MSN', 'role': 'CONTACT', 'email': 'allison.gruender@health.slu.edu', 'phone': '314-617-3406'}], 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Randall Otto, MD', 'role': 'CONTACT', 'email': 'randy.otto@health.slu.edu', 'phone': '314-617-2970'}, {'name': 'Allison Gruender, RN, MSN', 'role': 'CONTACT', 'email': 'allison.gruender@health.slu.edu', 'phone': '314-617-3406'}], 'overallOfficials': [{'name': 'Randall Otto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovice, LLC', 'class': 'UNKNOWN'}, {'name': 'American Shoulder and Elbow Surgeons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Randall J. Otto, MD', 'investigatorAffiliation': 'St. Louis University'}}}}