[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471859":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":181,"collaborators":183,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":26,"eligibilityCriteria":193,"healthyVolunteers":194,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":26,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"ULURU Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transforming Powder Dressing","EXPERIMENTAL","Half of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).",[13],"Device: Altrazeal (R) Transforming Powder Dressing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Dressing","ACTIVE_COMPARATOR","Half of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).",[19],"Other: Standard of Care burn dressing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Altrazeal (R) Transforming Powder Dressing","After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Standard of Care burn dressing","After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.",[15],[33],{"name":34,"affiliation":5,"role":35},"Jonathan Saxe, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Vai Shah","CONTACT","2149055145","vshah@uluruinc.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Susan St John, MSN","4123035379","sstjohn@uluru.com",[47,76,93,116,136,160],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University of California-Irvine","RECRUITING","Orange","California","92868","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-117.85311,33.78779,{"lat":59,"lon":58},[62,66,69,71,74],{"name":63,"role":39,"phone":64,"phoneExt":26,"email":65},"Lizette Spears","714-456-5840","lspiers@hs.uci.edu",{"name":67,"role":39,"phone":64,"phoneExt":26,"email":68},"Taina Aruju","taraujo@hs.uci.edu",{"name":70,"role":35,"phone":26,"phoneExt":26,"email":26},"Victor Joe, MD",{"name":72,"role":73,"phone":26,"phoneExt":26,"email":26},"Theresa Chin, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":26,"phoneExt":26,"email":26},"Kimberly Burton, PA",{"facility":77,"status":49,"city":78,"state":79,"zip":80,"country":53,"countryCode":54,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":56,"coordinates":82},[83,84],-77.03637,38.89511,{"lat":84,"lon":83},[87,91],{"name":88,"role":39,"phone":89,"phoneExt":26,"email":90},"Mary (Abby) Bellon","202 877 3519","Mary.A.Bellon@medstar.net",{"name":92,"role":35,"phone":26,"phoneExt":26,"email":26},"Jeffrey Shupp, MD",{"facility":94,"status":49,"city":95,"state":96,"zip":97,"country":53,"countryCode":54,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Jackson Memorial Hospital UM\u002FJMH Burn Center","Miami","Florida","33136",{"type":56,"coordinates":99},[100,101],-80.19366,25.77427,{"lat":101,"lon":100},[104,108,110,112,114],{"name":105,"role":39,"phone":106,"phoneExt":26,"email":107},"Lisa Otero, BA","305-585-1348","lao77@med.miami.edu",{"name":109,"role":35,"phone":26,"phoneExt":26,"email":26},"Carl I Schulman, MD",{"name":111,"role":73,"phone":26,"phoneExt":26,"email":26},"Joyce I Kaufman, MD",{"name":113,"role":73,"phone":26,"phoneExt":26,"email":26},"Louis R Pizano, MD",{"name":115,"role":73,"phone":26,"phoneExt":26,"email":26},"Shevonne S Satahoo, MD",{"facility":117,"status":49,"city":118,"state":119,"zip":120,"country":53,"countryCode":54,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"University of Louisville Health","Louisville","Kentucky","40202",{"type":56,"coordinates":122},[123,124],-85.75941,38.25424,{"lat":124,"lon":123},[127,131,134],{"name":128,"role":39,"phone":129,"phoneExt":26,"email":130},"Madison Rutledge","(502) 629-3327","madison.rutledge@louisville.edu",{"name":132,"role":39,"phone":26,"phoneExt":26,"email":133},"Michelle Broers","michelle.broers@uoflhealth.org",{"name":135,"role":35,"phone":26,"phoneExt":26,"email":26},"Matthew Bozeman, MD",{"facility":137,"status":49,"city":138,"state":139,"zip":140,"country":53,"countryCode":54,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Westchester Medical Center","Valhalla","New York","10595",{"type":56,"coordinates":142},[143,144],-73.77513,41.07482,{"lat":144,"lon":143},[147,151,154,156,158],{"name":148,"role":39,"phone":149,"phoneExt":26,"email":150},"Daniela Santamaria-Vargas, MSc","9144931528","Daniela.Santamaria-Vargas@wmchealth.org",{"name":152,"role":39,"phone":26,"phoneExt":26,"email":153},"Falyn Katzman, MPH","falyn.katzman@wmchealth.org",{"name":155,"role":35,"phone":26,"phoneExt":26,"email":26},"Joseph Turkowski, MD",{"name":157,"role":73,"phone":26,"phoneExt":26,"email":26},"Maryana Koshyk, PA-C",{"name":159,"role":73,"phone":26,"phoneExt":26,"email":26},"Rachelle Lodescar, MD",{"facility":161,"status":49,"city":162,"state":163,"zip":164,"country":53,"countryCode":54,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"University of Texas SW (Parkland)","Dallas","Texas","75235",{"type":56,"coordinates":166},[167,168],-96.80667,32.78306,{"lat":168,"lon":167},[171,175,177,179],{"name":172,"role":39,"phone":173,"phoneExt":26,"email":174},"Scarlett Dwyer","214 645-0445","Scarlett.Dwyer@utsouthwestern.edu",{"name":176,"role":35,"phone":26,"phoneExt":26,"email":26},"Caroline Park, MD",{"name":178,"role":73,"phone":26,"phoneExt":26,"email":26},"Chiaka Akarichi, MD",{"name":180,"role":73,"phone":26,"phoneExt":26,"email":26},"Rebecca Coffey, PhD",{"type":182,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[184],{"name":185,"class":186},"Navy Advanced Medical Development (NAMD) Command","UNKNOWN","100471859","phase-4-acute-partial-thickness-burn-study-comparing-transforming-powder-dressing-to-standard-of-care-dressing-100471859",false,"NCT05424354","Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing","Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds","Inclusion Criteria:\n\n* Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.\n* Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old\n* Wounds must be partial thickness, involving up to 20% of the total body surface area.\n* Burn injury should be less than 72 hours old\n* Willing and able to comply with protocol mandated scheduled study visits\u002Fclinical evaluations.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to TPD or its components\n\n  * Women who are pregnant, breast feeding, or plan to get pregnant during the study period.\n* Infected wounds\n* Presence of any full thickness (third degree) burns\n* Electrical burns\n* Heavily draining burns due to underlying chronic lymphedema or other conditions\n* Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.\n* History of poor wound healing and\u002For skin\u002Fimmune system condition\n\n  * Deemed by clinician not to be suitable\n* Unwilling or not able to provide consent or comply with protocol or required visits\n* Developmental disability\u002Fsignificant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol\n* Active alcohol or substance abuse",true,"ALL","18 Years","65 Years",{"count":199,"type":200},60,"ESTIMATED","INTERVENTIONAL",[203],"PHASE4","This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.",[206],"Wounds and Injuries",[208],"burn","2025-11-16",{"date":211,"type":212},"2025-11-19","ACTUAL",{"date":214,"type":212},"2022-05-26",{"date":216,"type":200},"2026-09-30",{"name":5,"class":6},6]