[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thermal-burn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thermal-burn":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100643030","phase-1-pilot-studies-testing-the-use-of-oral-amitriptyline-in-reducing-localized-burn-injury-induced-microvesicle-particle-release-100643030",false,"NCT07640061","Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release","Inclusion Criteria:\n\n* Adult Males and Females age 18 - 60\n* All skin types on Fitzpatrick Scale (Type I-VI)\n* Able to comprehend procedures and risks\n* Willing to participate and understand the informed consent document\n* Have reliable transportation\n\nExclusion Criteria:\n\n* Subjects should be otherwise healthy and not have any significant medical issues that could interfere with the study, in particular any heart arrythmias and not be on any prescription medications that could react with amitriptyline.\n* History of abnormal scarring (i.e., keloids) or poor wound healing.\n* No over the counter non-steroidal anti-inflammatory agents (aspirin, acetaminophen) or antioxidant vitamins (vitamin C) in past 14 days.\n* Currently taking known photosensitizers, anti-inflammatories, other tricyclic antidepressants, or systemic agents known to be aSMase inhibitors\n* Large tattoos in designated testing areas\n* Tanning bed use within last 3 months\n* UVB treatments in past 3 months\n* Medical history of abnormal scarring or diseases that could affect wound healing\n* Medical history of hypertension\u002Fhypotension or heart problems\n* Pregnant or nursing\n* History of sores in nares or easy bleeding from nares or other bleeding disorders.\n* Nasal piercings\n* Known allergies to lidocaine or amitriptyline",true,"ALL","18 Years","60 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to determine the amount of substances contained in skin known as microvesicle particles (MVP). The hypothesis to be tested in this study is that treatment with a single dose of 75mg of amitriptyline will block the MVP released from the skin from a very small localized burn injury.",[27,28],"Microvesicle Particles","Thermal Burn","NOT_YET_RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-10","ACTUAL",{"date":35,"type":21},"2027-06",{"date":37,"type":21},"2033-06",{"name":39,"class":40},"Wright State University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100609316","phase-3-plasma-resuscitation-early-for-evaluating-volume-and-endotheliopathy-of-thermal-injury-preevent-trial-100609316","NCT07212998","Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial","PREEVEnT","Inclusion Criteria:\n\n* Estimated ≥ 20% Total Body Surface Area burn\u002Fthermal injury with 2nd or 3rd degree depth\n* Anticipated admission to burn ICU\n\nExclusion Criteria:\n\n* Estimated rBaux score \\\u003C55\n* Not expected to survive \\>24 hours\n* Wearing NO PREEVENT opt-out bracelet\n* Age \\> 75 or \\\u003C 18 years of age\n* Concomitant traumatic injury with hemorrhagic shock\n* Isolated chemical burn\u002Finjury\n* Isolated deep electrical burn\u002Finjury\n* Known prisoner\n* Known pregnancy\n* Cardiac arrest with \\> 5 continuous minutes of CPR\n* Concern for anoxic injury\u002F fixed pupils bilaterally\n* Objection to study voiced by subject or family member at the scene or at the emergency department\u002Fburn center","75 Years",{"count":51,"type":21},750,[53],"PHASE3","The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 6-year (4-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resusciation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.",[56,28],"Burn Injury",[58,59],"burn","plasma resuscitation","2026-05-01",{"date":62,"type":33},"2026-05-04",{"date":64,"type":21},"2026-06",{"date":66,"type":21},"2030-05",{"name":68,"class":40},"Jason Sperry",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"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":77,"type":21},50,[53],"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.",[81,82,83,28,84],"Burns Degree Third","Burn (Disorder)","Burn Degree Second","Wound Heal",[86,87,88,89,90,91,92,93,94,95,96,97],"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":101,"type":33},"2025-04-02",{"date":103,"type":33},"2024-05-09",{"date":105,"type":21},"2026-01",{"name":107,"class":40},"XenoTherapeutics, Inc.",4]