[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624227":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":55,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":12,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"St. Louis University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No skin incision preparation","NO_INTERVENTION","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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Prontosan Wound Gel","EXPERIMENTAL","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.",[18],"Device: Prontosan Wound Gel",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"DEVICE","Applied to dermal layer of skin after incision is made for surgery.",[14],[25],{"name":26,"affiliation":5,"role":27},"Randall Otto, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","314-617-2970","randy.otto@health.slu.edu",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Allison Gruender, RN, MSN","314-617-3406","allison.gruender@health.slu.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Saint Louis University","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-90.19789,38.62727,{"lat":50,"lon":49},[53,54],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":12},{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},{"type":27,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Randall J. Otto, MD","Associate Professor",[59,62],{"name":60,"class":61},"Innovice, LLC","UNKNOWN",{"name":63,"class":6},"American Shoulder and Elbow Surgeons","100624227","reduction-of-bacterial-seeding-in-total-shoulder-arthroplasty-100624227",false,"NCT07406893","Reduction of Bacterial Seeding in Total Shoulder Arthroplasty","Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients","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","MALE","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82,83,84],"Joint Arthroplasty","Shoulder","Cutibacterium Acnes","Prosthetic Joint Infection",[86,87,88],"Antimicrobial wound gel","Dermal layer","Skin preparation","2026-03-06",{"date":91,"type":92},"2026-03-10","ACTUAL",{"date":94,"type":92},"2026-02-23",{"date":96,"type":75},"2026-12",{"name":5,"class":6},1]