[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"burn-degree-second\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:burn-degree-second":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,72,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100624895","the-use-of-cultured-dermal-epithelial-autografts-in-severely-burned-patients-100624895",false,"NCT07415577","The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients","Multicenter Cohort Study for the Use of Cultured Epithelial Autografts (CEA) or Cultured Dermal Epidermal Autografts (CDEA) in Severely Burned Patients","Swisskera","Inclusion Criteria:\n\n* Patients who have undergone treatment at the three Swiss burn centres and received grafts utilizing CEA since the introduction of the CEA technique in Switzerland (from 1985 to 2023) will be invited to participate in this study.\n* Availability of clinical data, including at minimum demographic information and the date and time of CEA\u002FCDEA transplantation.\n* Signed informed consent from the patient or his\u002Fher legal representative\u002Frelatives.\n\nExclusion Criteria:\n\n* Refusal of participation in the study by the patient or his\u002Fher legal representative\u002Frelatives.\n* Patients, who are, of any reason, unable to attend a study visit at one of the study sites or in their home","ALL",{"count":19,"type":20},236,"ESTIMATED","OBSERVATIONAL","The Swisskera project is a multicenter follow-up study at the three Swiss burn centers evaluating long-term outcomes after burn wound coverage with lab-grown epithelial grafts, specifically cultured epithelial autograft (CEA) and, where applicable, cultured dermal-epidermal autograft (CDEA). Patients who received CEA\u002FCDEA between 1985 and 2023 will be invited for a study visit , using available clinical records and standardized long-term scar and skin assessments.\n\nLong-term skin quality will be evaluated by comparing the previously transplanted area with a matched healthy skin reference site using non-invasive measurements (e.g., thickness, transepidermal water loss, hydration, elasticity, and color). Optional small punch biopsies may be obtained from transplanted areas (under local anesthesia or during clinically indicated anesthesia) for histological and immunohistochemical characterization of scar tissue remodeling, including collagen and elastin architecture, vascularization, nerve fiber ingrowth, inflammatory cell patterns, and melanocyte distribution.",[24,25,26,27],"Burn Degree Second","Burn Degree Third","Skin Transplantation","Full Thickness Skin Defects","NOT_YET_RECRUITING","2026-05-20",{"date":31,"type":32},"2026-05-26","ACTUAL",{"date":34,"type":20},"2026-12-01",{"date":36,"type":20},"2030-12-31",{"name":38,"class":39},"University Children's Hospital, Zurich","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100636662","development-and-clinical-study-of-burn-wound-nursing-dressing-based-on-sodium-hyaluronate-carbomer-composite-hydrogel-100636662","NCT07568600","Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel","Development and Preclinical Study of Nursing Dressing for Ⅰ\u002FShallow Ⅱ Degree Burn Wounds Based on Sodium Hyaluronate Carbomer Composite Hydrogel","Inclusion Criteria:\n\nPartial or full thickness burns requiring split thickness skin grafts Target burn wound size between 10 cm² and 1000 cm² Age ≥ 18 years Ability to read, write, and speak German Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations Informed consent will be obtained from the patient or from a legal representative if the patient is not able or competent to consent; in such cases, informed consent will also be obtained from the patient when he\u002Fshe regains competence Women of childbearing potential must test negative on a standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e.g., oral contraceptive, intrauterine device \\[IUD\\], intramuscular contraceptive, abstinence)\n\nExclusion Criteria:\n\nTarget wound has exposed hyaline cartilage Connective tissue disorder Previous skin graft failure at target wound site Total burn surface area ≥ 70% Infected target wound Immunosuppression therapy Chronic hemodialysis Steroid use Diabetes (Type I) Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X Allergy or sensitivity to chlorhexidine Pregnancy Simultaneous participation in another clinical trial","18 Years","55 Years",{"count":51,"type":20},30,"INTERVENTIONAL",[54],"NA","Development and clinical study of burn wound nursing dressing based on sodium hyaluronate carbomer composite hydrogel",[57,58,24],"Burn","Burn Contracture of Skin",[60,61,62],"hydrogel","epidermal growth factor","Benzalkonium chloride","2026-04-28",{"date":65,"type":32},"2026-05-06",{"date":67,"type":20},"2026-08-15",{"date":69,"type":20},"2028-10-20",{"name":71,"class":39},"The First Affiliated Hospital of Xinxiang Medical College",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":5},"100533242","phase-3-safety-and-efficacy-of-realskin-to-provide-complete-wound-closure-of-burn-wounds-as-an-alternative-to-autografting-100533242","NCT06223269","Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting","A Phase III Open-Label, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Mixed-Depth, Full-Thickness Burn Wounds as an Alternative to Autografting","Inclusion Criteria:\n\n1. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study\n2. Males or females age greater than or equal to 18 years old\n3. Total Burn Surface Area (TBSA) \\\u003C50% to include mixed depth and full-thickness burn wounds as defined as \"primarily full-thickness (FT) and deep-partial (DPT) thermal burns (e.g. \\>60% of the total burn area should be FT and DPT) before debridement\", and full-thickness burns for which surgical intervention is clinically indicated\n4. Having a mixed depth thermal burn wound including full thickness requiring skin grafting\n5. Biological females must have a negative serum pregnancy test at Screening and must not be nursing\n6. All subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following realSKIN placement, which includes a barrier method plus one or more of the following:\n\n   * Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, and the Depo-Provera shot)\n   * Intrauterine device (IUD)\n   * Male or female condoms with spermicide\n   * Diaphragm with spermicide\n   * Permanent tubal occlusive birth control system\n7. Sufficient area of burn wound for realSKIN and comparator autograft placement to not be located on face or hands or having a target graft site centered on high-impact areas such as joints, weight-bearing areas (e.g. soles of feet), or the inguinal region, per Investigator's judgment\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives\n3. Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (\\>10 mg prednisone\u002Fday), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), anti- proliferative agents, and other immunomodulators\n4. Active malignancy, including those requiring surgery, chemotherapy, and\u002For radiation in the past 5 years; non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed\n5. Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN\n6. Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and glutaraldehyde fixed porcine dermal matrix (e.g., EZ Derm)\n7. Patients with advanced or unstable\u002Funcontrolled comorbid conditions, such as advanced renal disease, diabetes mellitus and liver disease\n8. Patients with HbA1c ≥ 10.0%; specimen must be obtained for screening purposes if current (within past 3 months) value is not available\n9. Patients with a history of chronic end stage renal disease defined as MDRD CrCL \\\u003C 15mL\u002Fmin or receiving chronic dialysis\n10. Patients with a history of chronic liver disease or cirrhosis (Child-Pugh Score C); evidence of acute or chronic hepatitis B infection based on documented HBV serology testing\n11. Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum, Cytomegalovirus, herpes or varicella zoster; note: Successfully treated hepatitis C patients without evidence of end stage liver disease is allowed; if HCV antibody reactive, then HCV RNA must be undetectable\n12. Recent (within 3 months prior to study enrollment) MI, unstable angina leading to hospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic attack, endovascular procedure, or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (e.g., PCI, CABG, carotid or peripheral revascularization)\n13. Presence of venous or arterial vascular disorder directly affecting the area of burn wound\n14. Pre-existing haemolytic anemia\n15. Chronic malnourishment as determined by Investigator\n16. Inhalation injury as determined by bronchoscopic exam if available, or diagnosis at the time of screening\n17. Systemic anticoagulation at the time of treatment or INR \\> 2\n18. Documented evidence of wound infection at Screening\n19. Evidence of sepsis at Screening",{"count":80,"type":20},50,[82],"PHASE3","To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.",[85,86,24,87,88],"Burns Degree Third","Burn (Disorder)","Thermal Burn","Wound Heal",[90,91,92,93,94,95,96,97,98,99,100,101],"Full-thickness Burn","Complete Wound Closure","Durable Wound Closure","Autograft Alternative","3rd Degree Burn","Mixed-Depth Burn","Partial-thickness Burn","4th Degree Burn","Xenotransplant","Xenograft","Skin Xenotransplant","realSKIN","RECRUITING","2025-04-01",{"date":105,"type":32},"2025-04-02",{"date":107,"type":32},"2024-05-09",{"date":109,"type":20},"2026-01",{"name":111,"class":39},"XenoTherapeutics, Inc.",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":52,"phases":122,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100549913","phase-1-a-study-to-evaluate-the-safety-tolerability-and-efficacy-in-patients-with-burns-100549913","NCT06440239","A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)","A Phase 1\u002FPhase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s)","Inclusion Criteria:\n\n1. The combined TBSA of all burns is 10% or less.\n2. Nonsmoker and must not have used any tobacco products within 2 months prior to Screening.\n3. Phase 1 only: Participants with TBSA \\\u003C 10% who will undergo autologous skin grafting.\n4. Phase 2a only: Participants with dermal burns who are within 5 days from the date of wound and will be enrolled.\n5. Phase 1 only: Those who have confirmed at least 1 donor wound site with an even distribution of depth and extent of maximum 1% TBSA as judged by the Investigator.\n6. Phase 2a only: Those who have confirmed at least 2 dermal burn sites with similar depth and extent of 50 cm2 or more each as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Those who are allergic to or have experienced hypersensitivity to any components of the IP or its excipients such as gelatin or hyaluronic acid ingredients.\n2. Those with the following conditions for burns at the time of Screening in clinical trials:\n\n   1. Those who have suffered chemical or electrical burns (for Phase 2a only).\n   2. Persons requiring tracheal intubation or tracheostomy due to severe inhalation burns.\n   3. Those with burn wounds accompanied by trauma such as fractures or lacerations.\n   4. Persons with purulent infection of burn wounds.\n   5. Those who require treatment such as artificial mechanical ventilation, extracorporeal membrane oxygen therapy, or dialysis due to other concomitant diseases or conditions.\n3. History of or active bleeding or coagulation diseases (eg, hemophilia, von Willebrand's disease, thrombocytopenia, disseminated intravascular coagulation).\n4. History of or active autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, Behcet's disease, and\u002For multiple sclerosis.\n5. History of or active cardiovascular disease including clinically significant arrhythmias, uncontrolled hypertension, coronary artery disease (CAD), and\u002For prolonged QT interval (QTc \\> 450 msec for males and \\> 470 msec for females).\n6. History of or active ischemic, hemorrhagic, or anatomical neurovascular disease including, but not limited to, trans ischemic attack, cerebrovascular accident, arterio-venous malformation, or brain aneurysm.\n7. History of or active peripheral vascular disease such as deep vein thrombosis, pulmonary embolism, chronic venous insufficiency, claudication, or lymphedema.\n8. History of active pulmonary diseases including chronic obstructive pulmonary disease, pulmonary fibrosis, moderate-to-severe sleep apnea, and moderate-to-severe asthma.\n9. Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas.\n10. History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening.\n11. History of type 1 diabetes or active type 2 diabetes.\n12. History of severe endocrine disorders such as Cushing's disease, hypogonadism, and growth hormone deficiency.\n13. History or presence of severe active acute or chronic liver disease (eg, cirrhosis), hepatic insufficiency defined as Child Pugh Class A or higher, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), general hepatic disease including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × the upper limit of normal.\n14. Uncontrolled psychiatric disease including major depressive disorder, bipolar, anxiety disorder, or eating disorders such as bulimia.\n15. Those with serious diseases or condition that the Investigator believes may affect wound healing, such as a malnourished, clinically significant vitamin and\u002For mineral deficiencies.\n16. Positive test for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at the initial Screening Visit.\n17. History of systemic active infectious diseases (eg, sepsis, tuberculosis) at the initial Screening Visit.\n18. Those who have a history of malignant tumor or lymphoproliferative disease or have received an organ transplant within 5 years of initial Screening Visit.\n19. Participants who have received systemic steroids, immunosuppressants, antiplatelet agents or anticoagulants within 1 week before application of this clinical trial drug.\n20. History of abnormal wound healing such as keloids or hypertrophic scars.\n21. History of significant drug abuse within 12 months prior to Screening or positive urine drug test at Screening.\n22. Chronic kidney disease Stages 1 to 5.","70 Years",{"count":121,"type":20},40,[123,124],"PHASE1","PHASE2","For Phase 1, researchers will explore the safety, and tolerability of PMS-101 and determine the recommended Phase 2 dose (RP2D) using the donor site.\n\nFor Phase 2a, researchers will compare PMS-101 to a standard-of-care to see if PMS-101 works to treat mid-dermal burns.",[127,24],"Burns","2024-07-02",{"date":130,"type":32},"2024-07-05",{"date":132,"type":20},"2025-01-01",{"date":134,"type":20},"2025-02-28",{"name":136,"class":137},"Primoris Therapeutics","INDUSTRY",1]