[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579986":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":23,"centralContacts":51,"locations":61,"responsibleParty":86,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":23,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":23,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,16,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Xperience Antimicrobial Wash","EXPERIMENTAL","Xperience Antimicrobial Wash is composed of 32.5 g\u002FL citric acid, 31.3 g\u002FL sodium citrate, and 1.00 g\u002FL sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.",[13,14,15],"Device: Xperience Antimicrobial Wash","Diagnostic Test: Bacterial Cultures","Procedure: Shoulder Arthroplasty",{"label":17,"type":10,"description":18,"interventionNames":19},"3% hydrogen peroxide","To be applied along the entire dermis using a soaked surgical sponge following initial incision.",[20,14,15],"Device: Hydrogen Peroxide",{"label":22,"type":10,"description":18,"interventionNames":23},"10% povidone-iodine",null,{"label":25,"type":26,"description":27,"interventionNames":28},"Control","ACTIVE_COMPARATOR","No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures",[14,15],[30,34,38,41,46],{"type":31,"name":32,"description":33,"armGroupLabels":23,"otherNames":23},"DEVICE","Povidone-Iodine","Following electrocautery opening of the dermal layer, patients in the povidine-iodine group (Group B) will receive application of 10% sterile povidone-iodine along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of betadine, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).",{"type":31,"name":35,"description":36,"armGroupLabels":37,"otherNames":23},"Hydrogen Peroxide","Following electrocautery opening of the dermal layer, patients in the hydrogen peroxide group (Group A) will receive application of 3% sterile-filtered hydrogen peroxide along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of hydrogen peroxide a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).",[17],{"type":31,"name":9,"description":39,"armGroupLabels":40,"otherNames":23},"Following electrocautery opening of the dermal layer, patients in the patients in the Xperience group (Group C) will receive application of the Xperience antimicrobial wash (NextScience, Jacksonville, FL) (32.5 g\u002FL citric acid, 31.3 g\u002FL sodium citrate, and 1.00 g\u002FL sodium lauryl sulfate in sterile water) along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of Xperience, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).",[9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":23},"DIAGNOSTIC_TEST","Bacterial Cultures","Four C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture)",[17,25,9],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":23},"PROCEDURE","Shoulder Arthroplasty","All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.",[17,25,9],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":23,"email":56},"Chimdindu Obinero, BS","CONTACT","678-230-8592","cobiner1@hfhs.org",{"name":58,"role":54,"phone":59,"phoneExt":23,"email":60},"Jared Mahylis, MD","313-916-2181","jmahyli1@hfhs.org",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Henry Ford Health","RECRUITING","Detroit","Michigan","48202","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-83.04575,42.33143,{"lat":74,"lon":73},[77,78,79,81,84],{"name":53,"role":54,"phone":55,"phoneExt":23,"email":56},{"name":58,"role":54,"phone":59,"phoneExt":23,"email":60},{"name":58,"role":80,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"name":82,"role":83,"phone":23,"phoneExt":23,"email":23},"Stephanie Muh, MD","SUB_INVESTIGATOR",{"name":85,"role":83,"phone":23,"phoneExt":23,"email":23},"Linoj Samuel, PhD",{"type":80,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Jared Mahylis","Orthopaedic Surgeon, Prinicipal Investigator",[90],{"name":91,"class":92},"Next Science TM","INDUSTRY","100579986","post-incision-antimicrobial-wash-vs-c-acnes-in-shoulder-arthroplasty-100579986",false,"NCT06831422","Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty","Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Indicated and scheduled for primary shoulder arthroplasty.\n* Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,\n* Ability to read and understand English\n* Age ≥18 years\n* Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)\n\nExclusion Criteria:\n\n* Patient with history of prior native shoulder septic arthritis or infection\n* Prior surgery of affected shoulder\n* Proximal Humerus Fracture\n* Active infection\n* Cancer\n* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus\n* History of allergic reaction to citric acid-derived products","ALL","18 Years",{"count":103,"type":104},150,"ESTIMATED","INTERVENTIONAL",[107],"NA","The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:\n\n* Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)\n* Post-incision application of 3% hydrogen peroxide\n* Post-incision application of 10% povidone-iodine (betadine)\n* No post-incision treatment (control)\n\nThe investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.",[48,110],"Positive C. Acnes Culture",[48,112,113,114],"Antimicrobial","Post-incision wash","C. Acnes","2025-05-30",{"date":117,"type":118},"2025-06-04","ACTUAL",{"date":120,"type":118},"2025-05-05",{"date":122,"type":104},"2027-09",{"name":5,"class":6},1]