[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06384183":3,"trial-entities:NCT06384183":121,"trial-summary:NCT06384183":129},{"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":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":50,"sex":57,"minimum_age":27,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":65,"locations":69,"central_contacts":114,"overall_officials":115,"references":119,"see_also_links":120},"NCT06384183","KS-1000","Kerecis Real-World Fish Skin Graft Registry","Kerecis Real-World Fish Skin Graft Registry - \"ISACOD\"","ENROLLING_BY_INVITATION","2027-06","2024-08","2024-12-30","2024-08-07","Kerecis Ltd.","INDUSTRY",false,"Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices","This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for \"all comers\" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.",[19,20,21,22,23,24],"Wounds","Pressure Ulcer","Diabetic Foot Ulcer","Venous Leg Ulcer","Surgical Wound","Soft Tissue Reinforcement",[],"OBSERVATIONAL",null,[],{"count":30,"type":31},600,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Kerecis Fish Skin Graft","Patients already treated with a Kerecis device",[38],"Observational Group",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Fish Skin Graft Device Related failure","Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal)","12 months",{"measure":45,"description":46,"timeFrame":43},"Fish Skin Graft Device related allergy","Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and\u002For autoimmune reaction (with or without documented auto-antibody development)",{"measure":48,"description":49,"timeFrame":43},"Target Wound Infection","Proportion of patients who develop target wound infection",[51,54],{"measure":52,"description":53,"timeFrame":43},"Complete Wound Healing","The Time in weeks to complete healing",{"measure":55,"description":56,"timeFrame":43},"Complete Wound Closure","Proportion of participants who experience complete wound closure","ALL",{"inclusion":59,"exclusion":62,"raw_text":64},[60,61],"Provided informed consent","Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date",[63],"None","Inclusion Criteria:\n\n* Provided informed consent\n* Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date\n\nExclusion Criteria:\n\n* None",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70,79,83,91,99,106],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"MCR Health","Sarasota","Florida","34237","United States",{"lat":77,"lon":78},27.33643,-82.53065,{"facility":80,"city":72,"state":73,"zip":81,"country":75,"geoPoint":82},"University Park","34243",{"lat":77,"lon":78},{"facility":84,"city":85,"state":86,"zip":87,"country":75,"geoPoint":88},"Cone Health Ortho Care Greensboro","Greensboro","North Carolina","27401",{"lat":89,"lon":90},36.07264,-79.79198,{"facility":92,"city":93,"state":94,"zip":95,"country":75,"geoPoint":96},"Feet First Institute of Beavercreek","Beavercreek","Ohio","45432",{"lat":97,"lon":98},39.70923,-84.06327,{"facility":100,"city":101,"state":94,"zip":102,"country":75,"geoPoint":103},"ABC Podiatry","Columbus","43213",{"lat":104,"lon":105},39.96118,-82.99879,{"facility":107,"city":108,"state":109,"zip":110,"country":75,"geoPoint":111},"South Texas Skin Cancer Center","San Antonio","Texas","78215",{"lat":112,"lon":113},29.42412,-98.49363,[],[116],{"name":117,"affiliation":13,"role":118},"Anne Swearingen","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":122,"biomarkers":128},[123,124,24,125,126,127],"Diabetic foot ulcer","Pressure Sore","Stasis ulcer","Surgical wound","Wound",[],{"nct_id":4,"found":15,"summary":27,"prompt_version":27}]