[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654863":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":23,"studyPopulation":47,"armGroups":48,"interventions":58,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":64,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":23,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":23,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":23,"briefSummary":80,"conditions":81,"keywords":23,"overallStatus":93,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":23},{"fullName":5,"class":6},"Integra LifeSciences Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Complete Wound Closure","Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care.","Up to 12 months following the initial UBM application.",[14,17],{"measure":15,"description":16,"timeFrame":12},"Time to Complete Wound Closure","Time from the initial UBM application to documented complete wound closure.",{"measure":18,"description":19,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","Incidence of treatment-emergent adverse events reported during the registry period, defined as adverse events occurring after the initial application of a UBM product that were not present prior to treatment or that worsened in intensity or frequency following treatment.",[21,25,28,31,34,37,40],{"measure":22,"description":23,"timeFrame":24},"Wound Area or Volume Reduction Over Time",null,"Up to 12 months.",{"measure":26,"description":27,"timeFrame":24},"Percentage of Skin Graft Take","Percentage of skin graft take at first dressing take-down and\u002For patient discharge, if available.",{"measure":29,"description":30,"timeFrame":24},"Number of UBM Applications","Number of UBM device applications during the treatment period.",{"measure":32,"description":33,"timeFrame":24},"Time Between UBM Applications","Time interval between UBM device applications.",{"measure":35,"description":36,"timeFrame":24},"Pain Medication Utilization","Prescription of pain medications, including morphine equivalents and GABA-modulating agents.",{"measure":38,"description":39,"timeFrame":24},"Length of Hospital Stay","Duration of hospitalization associated with wound treatment.",{"measure":41,"description":42,"timeFrame":43},"Resting Pain Intensity","Resting pain intensity measured on a 0-10 Numeric Rating Scale (NRS).","Months 3, 6, and 12",{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":45,"timePerspective":46,"maskingInfo":23},"COHORT","OTHER","Adult patients treated with eligible urinary bladder matrix (UBM) products for qualifying wounds in routine clinical practice. The registry includes both retrospectively identified patients and prospectively enrolled patients receiving standard-of-care treatment at participating U.S. sites.",[49,54],{"label":50,"type":23,"description":51,"interventionNames":52},"Retrospective Cohort","Patients with qualifying wounds previously treated with an eligible UBM product whose clinical data are collected through abstraction of existing medical records. No study-specific interventions, procedures, or follow-up visits are required. Participants are enrolled under an IRB-approved waiver of informed consent, where applicable.",[53],"Device: Urinary Bladder Matrix (UBM) Products",{"label":55,"type":23,"description":56,"interventionNames":57},"Prospective Cohort","Patients receiving treatment with an eligible UBM product for a qualifying wound who provide informed consent and are followed through routine standard-of-care clinical visits. Clinical data are collected prospectively from the medical record without protocol-mandated interventions or visits.",[53],[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":23},"DEVICE","Urinary Bladder Matrix (UBM) Products","Commercially available UBM wound management products used as part of routine clinical practice. Treatment selection, application frequency, and wound management approach are determined by the treating clinician and are not dictated by the registry protocol.",[55,50],{"type":65,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100654863","urinary-bladder-matrix-ubm-registry-100654863",false,"NCT07805798","Urinary Bladder Matrix (UBM) Registry","Real-World Registry of Urinary Bladder Matrix","Inclusion Criteria\n\n* Adults aged ≥21 years at the time of initial urinary bladder matrix (UBM) product application.\n* Received or are receiving an eligible UBM product for treatment of a qualifying wound, including:\n\nPressure ulcer (Stage III\u002FIV) Necrotizing soft tissue infection (NSTI) Fournier's gangrene Pilonidal cyst Open abdomen Hidradenitis suppurativa Acute or chronic lower extremity wound Surgical incisional wound (retrospective cohort only)\n\n* For retrospective participants, medical records must contain sufficient source documentation to support data abstraction, including wound characteristics, UBM treatment information, and post-treatment outcome data.\n* For prospective participants, written informed consent must be obtained prior to any registry-related data collection, and the participant must be expected to remain available for follow-up through approximately 12 months after the index UBM application.\n\nExclusion Criteria\n\n* Wound treated with a skin substitute prior to UBM treatment.\n* Wound not treated with a UBM product.\n* Full-thickness (third-degree) burn wound.\n* Participation in another interventional clinical trial that, in the opinion of the investigator, may affect wound-healing outcomes.\n* Known terminal condition, limited life expectancy, inadequate medical records, or any other circumstance that, in the opinion of the investigator, would preclude meaningful participation in the registry or collection of adequate outcome data.","ALL","21 Years",{"count":76,"type":77},300,"ESTIMATED","12 Months","OBSERVATIONAL","The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products. The study will evaluate patient characteristics, treatment patterns, and clinical outcomes to better understand how UBM products are used in routine clinical practice and the outcomes experienced by patients over time.",[82,83,84,85,86,87,88,89,90,91,92],"Tissue Repair","Soft Tissue Reconstruction","Wound Management","Pressure Ulcer (PU)","Necrotizing Soft Tissue Infection","Fournier's Gangrene","Pilonidal Cyst","Open Abdomen","Hidradenitis Suppurativa (HS)","Lower Extremity Wound","Incisional","NOT_YET_RECRUITING","2026-09-01",{"date":96,"type":97},"2026-09-04","ACTUAL",{"date":99,"type":77},"2026-08-31",{"date":101,"type":77},"2029-12-31",{"name":5,"class":6}]