[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474819":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":36,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":36,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":36,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":36,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The Metis Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suprathel® dressing","EXPERIMENTAL","The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use",[13],"Other: Suprathel®",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Suprathel®","Application of standard of care dressing.®",[15,9],[25],"standard of care",[27],{"name":28,"affiliation":29,"role":30},"Rodney Chan, MD","Metis Foundation","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Victoria Diaz, RN","CONTACT","2105691140",null,"Diaz@metisfoundationusa.org",{"name":39,"role":34,"phone":36,"phoneExt":36,"email":40},"Kristin Anselmo","Anselmo@metisfoundationusa.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"North Carolina Jaycee Burn Center","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-79.05584,35.9132,{"lat":54,"lon":53},[57,59],{"name":58,"role":34,"phone":36,"phoneExt":36,"email":36},"Carter",{"name":60,"role":30,"phone":36,"phoneExt":36,"email":36},"Booker King, MD",{"type":62,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100474819","suprathel-use-during-prolonged-field-care-to-promote-healing-and-reduce-the-need-for-grafting-of-burn-wounds-100474819",false,"NCT05462860","Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds","Inclusion Criteria:\n\n* Male or Female ≥18 years and ≤75 years\n* Acute partial thickness burns by friction, contact, scalding from hot liquids and flame\n* TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet\n* TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)\n* Subject is able and willing to sign Informed Consent or via legally authorized representative\n\nExclusion Criteria:\n\n* Study Wound due to electrical, radioactive, or frostbite-related injury\n* Infection of wounds in the study area at admission per Investigator or treating physician discretion\n* Pregnancy\u002Flactation\n* Subjects who are unable to follow the protocol or who are likely to be non-compliant\n* Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study\n* Prisoners\n* Life expectancy less than 6 months\n* Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment","ALL","18 Years","75 Years",{"count":73,"type":74},21,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.",[80,81],"Wound of Skin","Burns","2025-04-08",{"date":84,"type":85},"2025-04-10","ACTUAL",{"date":87,"type":85},"2024-09-18",{"date":89,"type":74},"2026-06-29",{"name":5,"class":6},1]