[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":44,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":44,"enrollmentInfo":80,"targetDuration":44,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":96,"whyStopped":44,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylene Blue Photodynamic Therapy","EXPERIMENTAL","Participants in this arm will receive methylene blue-mediated photodynamic therapy during routine burn dressing changes. Methylene blue will be applied to the burn wound surface followed by illumination with blue light using a clinical light source. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.",[13,14],"Drug: Methylene Blue","Device: Blue Light Illumination",{"label":16,"type":17,"description":18,"interventionNames":19},"Light Therapy Alone","ACTIVE_COMPARATOR","Participants in this arm will receive blue light illumination during routine burn dressing changes without application of methylene blue. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methylene Blue","Methylene blue will be applied topically to the burn wound surface prior to illumination. When activated by visible blue light, methylene blue acts as a photosensitizer that generates reactive oxygen species capable of killing bacteria. Methylene blue-mediated photodynamic therapy will be administered during two consecutive burn dressing changes.",[9],[27],"Methylthioninium Chloride",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Blue Light Illumination","Burn wounds will be illuminated using a clinical blue light source during routine dressing changes. In the experimental arm, illumination will occur after topical application of methylene blue to activate photodynamic therapy. In the control arm, illumination will occur without methylene blue application.",[16,9],[34],"Bili-lamp; Blue Light Phototherapy",[36],{"name":37,"affiliation":38,"role":39},"Nicole A. Wilson, PhD, MD","University of Oklahoma Health Sciences","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","405-271-5922",null,"nicole-wilson@ou.edu",[47],{"facility":48,"status":44,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"OU Health - Burn Unit","Oklahoma City","Oklahoma","73104","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-97.51643,35.46756,{"lat":58,"lon":57},[61,62,63],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":37,"role":39,"phone":44,"phoneExt":44,"email":44},{"name":64,"role":65,"phone":44,"phoneExt":44,"email":44},"Arthur Grimes, MD","SUB_INVESTIGATOR",{"type":67,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[69],{"name":70,"class":6},"University of Rochester","100630984","early-phase-1-topical-methylene-blue-photodynamic-therapy-mb-pdt-for-burn-wound-infection-100630984",false,"NCT07494773","Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection","Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study","Inclusion\n\n* Age ≥18\n* Partial- or full-thickness burn with partial-thickness component\n* Expected ≥7 days dressing changes\n* Able to consent\n\nExclusion\n\n* Pregnancy or lactation\n\n  o Pregnancy status will be determined by review of the medical record and, when clinically indicated per institutional policy, standard-of-care pregnancy testing. No additional pregnancy testing will be performed solely for research purposes.\n* Current use of SSRIs, SNRIs, MAO inhibitors, and other serotonergic agents\n* Inability to tolerate wound exposure\n* Inability to consent\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency","ALL","18 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria.\n\nThis randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.",[88,89],"Burns","Wound Infection",[91,23,92,93,94,95],"Photodynamic Therapy","Burn Wound Infection","Antimicrobial Photodynamic Therapy","Reactive Oxygen Species","Burn Wound Bacterial Burden","NOT_YET_RECRUITING","2026-05-14",{"date":99,"type":100},"2026-05-19","ACTUAL",{"date":102,"type":82},"2026-06",{"date":104,"type":82},"2028-05-31",{"name":5,"class":6},1]