[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CUTISS AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100573382","phase-iii-study-with-an-autologous-dermo-epidermal-skin-substitute-for-the-treatment-of-burns-in-adults-and-adolescents-100573382",false,"NCT06745557","Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents","A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns","Inclusion Criteria:\n\n* Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated\n* Patients of either sex aged ≥12 years\n* Signed informed consent from the patient and\u002For legally authorised representative\n\nExclusion Criteria:\n\n* Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head\u002Fneck)\n* Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies\n* Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen \\[HbsAg\\] or immunoglobulin M total hepatitis B core antibody \\[anti-HBc\\]), active hepatitis C infection (hepatitis C virus \\[HCV\\] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion\n* Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol\u002Fmol and\u002For systemic skin and connective tissue diseases\n* Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission\n* Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)\n* Previous treatment with denovoSkin™\n* Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and \\\u003C30 days for all other IMPs\n* Patients unwilling or unable to comply with procedures required in this clinical study protocol\n* Pregnant or lactating women\n* Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate \\\u003C1% per year) throughout the study and\u002For unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting\n* Patient is the Investigator, one of his\u002Fher family members, employees, and other dependent persons","ALL","12 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.",[26],"Burns",[26,28,29,30,31,32,33],"Skin","Scars","Wound healing","Dermis","Epidermis","Thermal burns","RECRUITING","2026-08-06",{"date":37,"type":38},"2026-08-10","ACTUAL",{"date":40,"type":38},"2024-12-13",{"date":42,"type":20},"2029-06-30",{"name":44,"class":45},"CUTISS AG","INDUSTRY",19,""]