[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636172":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":17,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":17,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":17,"maxAge":17,"enrollmentInfo":63,"targetDuration":17,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":17,"overallStatus":39,"whyStopped":17,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rapid Tissue-Engineered Skin Group","EXPERIMENTAL","Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）",[13],"Procedure: Rapid Tissue-Engineered Skin",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Composite Skin Graft Group","ACTIVE_COMPARATOR",null,[19],"Procedure: Traditional Composite Skin Graft",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"PROCEDURE","Rapid Tissue-Engineered Skin","Autologous split-thickness skin (0.15-0.2 mm) is harvested from the donor site at a donor-to-wound area ratio of 1:20-30. The harvested skin is processed using a specialized cell sorter to isolate autologous epidermal stem cells (EpiSCs) with \\>93% viability within 30 minutes. The cell suspension is adjusted to a concentration of ≥1×10⁶ cells\u002FmL and loaded onto a tissue-engineered scaffold via spraying or immersion (3-5 minutes). The cell-seeded scaffold is then applied to the wound bed. Depending on wound condition: (1) One-step procedure: scaffold and a split-thickness skin graft (0.15-0.2 mm) are applied simultaneously; (2) Two-step procedure: scaffold is implanted first, followed by split-thickness skin graft at 14±3 days post-primary surgery. Negative pressure wound therapy (-100 to -125 mmHg) is applied as needed.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":17},"Traditional Composite Skin Graft","The same tissue-engineered scaffold (without cell loading) is used. Autologous split-thickness skin graft (0.15-0.2 mm thickness) is harvested. The acellular scaffold is applied to the debrided wound bed followed by coverage with the split-thickness skin graft. The surgical procedure, postoperative wound care, negative pressure wound therapy (-100 to -125 mmHg when indicated), and follow-up protocol are identical to those in the experimental arm. This comparator represents the current standard of care for composite skin grafting in the participating centers.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":17,"email":35},"Hu Zhicheng","CONTACT","87755766-8265","huzhch5@mail.sysu.edu.cn",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":17,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":38,"role":33,"phone":34,"phoneExt":17,"email":35},{"type":53,"investigatorFullName":32,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Clinical Professor","100636172","rapid-construction-of-tissue-engineered-skin-for-repairing-difficult-to-heal-wounds-100636172",false,"NCT07562230","Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds","Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study","Inclusion Criteria:\n\n* All-age population\n\nWounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers）\n\nCompleted wound bed preparation （no necrotic tissue, infection controlled）\n\nSigned informed consent and agreement to use tissue-engineered materials and long-term follow-up\n\nExclusion Criteria:\n\n* History of allergy to allogeneic\u002Fxenogeneic tissue-engineered scaffolds or collagen materials\n\nSevere immunosuppression （HIV\u002FAIDS, long-term immunosuppressant use）\n\nMalignant tumors, uncontrolled systemic infection （CRP \\> 50 mg\u002FL）， or organ failure （Child-Pugh Class C）\n\nMental illness preventing compliance with treatment or follow-up\n\nPregnant or lactating women","ALL",{"count":64,"type":65},1000,"ESTIMATED","INTERVENTIONAL",[68],"NA","This multicenter real-world study evaluates the efficacy and safety of a novel technique for rapid intraoperative construction of tissue-engineered skin using autologous epidermal stem cells （EpiSCs） for repairing difficult-to-heal wounds. Eligible patients are randomized to receive either: （1） the experimental intervention （rapidly constructed EpiSCs-loaded scaffold combined with split-thickness skin graft via one-step or two-step procedure）， or （2） control intervention （acellular scaffold combined with split-thickness skin graft）. The primary outcome is the complete wound healing rate at 4 weeks post-surgery. Secondary outcomes include wound recurrence, scar quality （VSS\u002FPOSAS）， functional recovery （sweat test）， mortality, amputation rate, and safety profile.",[71],"Wounds and Injuries \u002F Mortality","2026-04-27",{"date":74,"type":75},"2026-05-01","ACTUAL",{"date":77,"type":75},"2026-01-01",{"date":79,"type":65},"2030-12-01",{"name":5,"class":6},1]