[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07721415":3,"trial-entities:NCT07721415":88,"trial-summary:NCT07721415":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":17,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":68,"locations":71,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT07721415","SNAM20251199","Iodine Drapes Used in TSA","Effect of Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study","ENROLLING_BY_INVITATION","2029-12-31","2026-07","2026-07-23","2026-01-05","tnicholson","OTHER",false,"This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery",null,[19,20,21],"Total Shoulder Arthroplasty","Iodine","Shoulder Surgery",[],"INTERVENTIONAL","PREVENTION",[26],"PHASE4",{"count":28,"type":29},128,"ESTIMATED",[31,38,43],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","Total shoulder arthroplasty","Participant will have total shoulder arthroplasty surgery",[36,37],"Iodine Drapes","Non-iodine drapes",{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","Iodine impregnated drapes","After cleaning the shoulder area in preparation for surgery, the area will be covered and draped using iodine impregnated drapes prior to the start of the participants surgery.",[36],{"type":32,"name":44,"description":45,"armGroupLabels":46},"Tissue Culture Samples","One deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery.",[36,37],[48],{"measure":49,"description":50,"timeFrame":51},"Culture positivity rate","One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.","13 days",[],"MALE","18 Years",true,{"inclusion":57,"exclusion":62,"raw_text":67},[58,59,60,61],"Adults ≥ 18 years","Written informed consent","Elective primary total shoulder arthroplasty","Male patients",[63,64,65,66],"Prior surgery on the operative shoulder","Iodine allergy","Participation in other clinical trials","Active infection","Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Written informed consent\n* Elective primary total shoulder arthroplasty\n* Male patients\n\nExclusion Criteria:\n\n* Prior surgery on the operative shoulder\n* Iodine allergy\n* Participation in other clinical trials\n* Active infection",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Rothman Orthopaedic Institute","Philadelphia","Pennsylvania","19107","United States",{"lat":79,"lon":80},39.95238,-75.16362,[],[83],{"name":84,"affiliation":73,"role":85},"Surena Namdari, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Reverse prosthetic total arthroplasty of shoulder",[],{"nct_id":4,"found":55,"summary":93,"prompt_version":103},{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This interventional study plans to enroll 128 adult male participants. It will directly compare the rate of positive cultures in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes.","completed","Iodine Drapes Used in Total Shoulder Arthroplasty Study","This study is looking at whether using iodine-impregnated drapes during total shoulder arthroplasty (shoulder replacement surgery) can help reduce infections. You might be able to join if you are an adult male, 18 years or older, who is planning to have elective primary total shoulder arthroplasty. You cannot have had previous surgery on that shoulder, an iodine allergy, or an active infection. The study will compare how often bacteria grow in tissue samples taken after surgery when iodine-impregnated drapes are used versus when they are not. The goal is to see if these special drapes can lower the rate of positive cultures (meaning bacteria are found) 13 days after surgery. The current recruitment status is unclear.","The main outcome of the study, culture positivity rate, will be measured 13 days after surgery.",116,"You will undergo total shoulder arthroplasty surgery. After cleaning, your shoulder area will be covered with either iodine-impregnated or non-iodine-impregnated drapes. A deep tissue swab will be taken after your shoulder implant is placed.","Not stated in the trial record.",[33],"v2"]