[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554770":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":24,"responsibleParty":43,"collaborators":45,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":24,"overallStatus":74,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":24},{"fullName":5,"class":6},"The Metis Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SupraSDRM®","EXPERIMENTAL","Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.",[13],"Device: SupraSDRM®",{"label":15,"type":16,"description":11,"interventionNames":17},"SOC Skin Substitute","ACTIVE_COMPARATOR",[18],"Device: NovoSorb® BTM",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"NovoSorb® BTM","NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140",[15],[30],{"name":31,"affiliation":32,"role":33},"Rodney Chan, MD","Metis Foundation","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Victoria Diaz, RN","CONTACT","2105691140","Diaz@metisfoundationusa.org",{"name":41,"role":37,"phone":24,"phoneExt":24,"email":42},"Kristin Anselmo","kanselmo@metisfoundationusa.org",{"type":44,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[46,48,51],{"name":47,"class":6},"The University of Texas Medical Branch, Galveston",{"name":49,"class":50},"United States Department of Defense","FED",{"name":52,"class":53},"The United States Army Institute of Surgical Research","UNKNOWN","100554770","a-prospective-study-using-suprasdrm-in-promoting-healing-and-reducing-the-time-to-grafting-of-full-thickness-wounds-100554770",false,"NCT06503406","A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds","Inclusion Criteria:\n\n* Patient age ≥18 years and ≤85 years\n* Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon\n* Wound size ≥ 5cm2 not immediately suitable for graft application\n* Subject or legally authorized representative is able and willing to sign informed consent\n\nExclusion Criteria:\n\n* Study wound may not include areas of the face, and neck and genitalia.\n* Wound with metal hardware exposure\n* Pressure sores\n* Wounds with residual malignancy\n* Wound infection at the time of planned wound dressing application\n* Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit)\n* Pregnancy\u002Flactation\n* Subjects who are unable to follow the protocol or who are likely to be non-compliant\n* Subjects with uncontrolled diabetes (defined by Hgb A1C \\>10)\n* Subjects who are receiving systemic steroids or immune suppressive treatment\n* Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials.\n* Prisoners","ALL","18 Years","85 Years",{"count":64,"type":65},24,"ESTIMATED","INTERVENTIONAL",[68],"NA","This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.",[71,72,73],"Surgical Wound","Burns","Trauma Injury","NOT_YET_RECRUITING","2025-02-19",{"date":77,"type":78},"2025-02-21","ACTUAL",{"date":80,"type":65},"2025-03",{"date":82,"type":65},"2026-10",{"name":5,"class":6}]