[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605064":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":55,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":21,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":21,"enrollmentInfo":75,"targetDuration":21,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with standard or photosynthetic dermal regeneration matrices in same patient.","EXPERIMENTAL","Surgical implantation of dermal regeneration matrices:\n\nPrimary procedure: Participants will receive both a standard dermal regeneration matrix (DRM; control) and a photosynthetic dermal regeneration matrix (PDRM; experimental), which is seeded with Chlamydomonas reinhardtii microalgae. The two matrices will be implanted into randomized areas of the same full-thickness wound or into separate full-thickness wounds on the same patient. A light-emitting dressing will be placed over the wound area to activate photosynthesis in the PDRM, facilitating localized oxygen production.\n\nSecondary procedure: Approximately 21 days after matrix implantation, once sufficient granulation tissue has formed, an autologous split-thickness skin graft will be applied to the wound areas.",[13,14],"Biological: Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.","Procedure: Autologous split-thickness skin grafting over implanted matrices",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.","Under sterile conditions and appropriate anesthesia, standard dermal regeneration matrices (DRMs) and photosynthetic dermal regeneration matrices (PDRMs), containing live photosynthetic microalgae, are implanted in separate wound areas or in anatomically distinct wounds on the same patient. Each site is then covered with a transparent adhesive dressing. In the experimental (PDRM) area, a light-emitting dressing is applied to stimulate photosynthesis and promote localized oxygen production.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Autologous split-thickness skin grafting over implanted matrices","Approximately 21 days after the initial intervention, and once the wound bed meets predefined grafting criteria based on clinical evaluation, an autologous dermo-epidermal skin graft is performed.",[9],[28],{"name":29,"affiliation":5,"role":30},"José Tomás Egaña, PhD","STUDY_DIRECTOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Anil Sadarangani, PhD, MBA","CONTACT","+56-942766405","asadaran@gmail.com",{"name":29,"role":34,"phone":38,"phoneExt":21,"email":39},"+56-961555928","jte@uc.cl",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":21},"Hospital del Trabajador","RECRUITING","Santiago","RM","7501239","Chile","CL",{"type":50,"coordinates":51},"Point",[52,53],-70.64827,-33.45694,{"lat":53,"lon":52},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Jose Tomas Egaña","Associate Professor",[60,62],{"name":61,"class":6},"Hospital del Trabajador de Santiago",{"name":63,"class":64},"SymbiOx Inc.","UNKNOWN","100605064","phase-2-efficacy-of-a-photosynthetic-dermal-matrix-for-the-treatment-of-full-thickness-skin-wounds-100605064",false,"NCT07157657","Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds","Evaluation of the Efficacy of a Dermal Regeneration Matrix With Photosynthetic Microalgae for the Treatment of Patients With Full-Thickness Skin Wounds: Phase 2 Study","Inclusion Criteria:\n\nPatients covered by social insurance law or under the \"Complementary Service Sales\" (VSC) program, aged 18 years or older.\n\n* Presence of full-thickness skin wounds.\n* Wounds with homogeneous granulation tissue.\n* Wound size between 25 cm² and 200 cm².\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of a psychiatric disorder that may impair decision-making or adherence to treatment.\n* Presence of an acute medical condition unrelated to the wound at the time of enrollment.\n* Wound with exposed bone, tendon, or major blood vessels.\n* Psychosocial conditions that may hinder adherence to the study protocol.",true,"ALL","18 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds.\n\nThe primary objectives are to determine whether the use of photosynthetic scaffolds enhances wound granulation and reduces infection rates compared to standard dermal regeneration scaffolds. Additionally, the quality of the regenerated skin will be assessed and compared between treatment types.\n\nParticipants will:\n\n* Receive treatment with either standard dermal regeneration scaffolds or identical scaffolds containing photosynthetic microalgae. These treatments will be applied either to randomly assigned areas of the same wound or to different wounds on the same patient.\n* Undergo regular follow-up assessments to monitor wound healing progress, infection rates, graft integration, and the qualiy of the regenerated skin.\n* Complete self-assessment questionnaires regarding their experience and perceived outcomes.",[83,84],"Cronic Full-thinkness Skin Wound","Acute Full-thickness Skin Wound",[86,87,88,89,90],"Full-thickness skin wounds","Scaffolds for dermal regeneration","Matrix for dermal regeneration","Photosynthetic biomaterials","Oxygen producing biomaterials","2025-09-04",{"date":93,"type":94},"2025-09-05","ACTUAL",{"date":96,"type":94},"2025-06-24",{"date":98,"type":77},"2028-05",{"name":5,"class":6},1]