[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573332":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":24,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Akron Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"10% Povidone-Iodine Arm","ACTIVE_COMPARATOR","A single-use sealed packet of three 10% povidone-iodine swabs will be opened via standard sterile technique. Three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing an Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, an additional culture will be obtained with an Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with an Eswab just prior to wound closure.",[13],"Biological: 10% Povidone-Iodine Arm",{"label":15,"type":10,"description":16,"interventionNames":17},"Saline Arm","Three sterile swabs will be provided for soaking in sterile saline. Three applications of sterile saline along the length of the subdermis, using each of the 3 swabs soaked in sterile saline. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing and Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, and additional culture will be obtained with and Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with and Eswab just prior to wound closure.",[18],"Procedure: Saline Arm",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","A second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision.",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":24},"PROCEDURE","An application of saline in the subdermal layer after making an incision.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Alexandria Rundell, BS","CONTACT","330-543-3193","arundell@akronchildrens.org",{"name":36,"role":32,"phone":33,"phoneExt":24,"email":37},"Lorena Floccari, MD","lfloccari@akronchildrens.org",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Akron","Ohio","44308","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.51901,41.08144,{"lat":50,"lon":49},[53,54,55,57,60,62,63],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":36,"role":32,"phone":33,"phoneExt":24,"email":37},{"name":36,"role":56,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":24,"phoneExt":24,"email":24},"Todd Ritzman, MD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":24,"phoneExt":24,"email":24},"Richard Steiner, PhD",{"name":31,"role":59,"phone":24,"phoneExt":24,"email":24},{"name":64,"role":59,"phone":24,"phoneExt":24,"email":24},"Xiaotian Zheng, PhD",{"type":56,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Lorena Floccari","Orthopedic Surgeon, Director Spine Center of Excellence, Director Spine Research","100573332","phase-4-safety-and-efficacy-of-subdermal-betadine-during-posterior-spinal-fusion-100573332",false,"NCT06744907","Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion","Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion","Inclusion Criteria\n\n* Males and females\n* Undergoing primary posterior spinal fusion of the thoracic and\u002For lumbar spine\n* English Speaking\n\nExclusion Criteria\n\n* Patients who have undergone prior spinal surgery\n* Undergoing procedures other than primary posterior spinal fusion of the thoracic and\u002For lumbar spine (cervical fusion, anterior surgery, growth-friendly instrumentation)\n* Any contraindication to povidone-iodine, including pregnancy, allergy, or prior treatment with radioiodine","ALL","26 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal fusion.",[85],"Spinal Fusion",[85,87,88,89,90],"Lumbar Spine","Thoracic Spine","Subdermal Betadine","Microbacterial bioburden","2025-01-09",{"date":93,"type":94},"2025-01-13","ACTUAL",{"date":96,"type":94},"2025-01-03",{"date":98,"type":79},"2026-11",{"name":5,"class":6},1]