About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥21 years at the time of initial urinary bladder matrix (UBM) product application.
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.
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.
Disqualifiers
Wound treated with a skin substitute prior to UBM treatment.
Wound not treated with a UBM product.
Full-thickness (third-degree) burn wound.
Participation in another interventional clinical trial that, in the opinion of the investigator, may affect wound-healing outcomes.
Trial population
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.
Trial design
Cohort
Other
Treatments tested in this trial
Urinary Bladder Matrix (UBM) Products
DeviceCommercially 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Complete Wound Closure
Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care.
Secondary outcomes
Time to Complete Wound Closure
Time from the initial UBM application to documented complete wound closure.
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.
Other outcomes
Wound Area or Volume Reduction Over Time
Percentage of Skin Graft Take
Percentage of skin graft take at first dressing take-down and/or patient discharge, if available.
Number of UBM Applications
Number of UBM device applications during the treatment period.
Time Between UBM Applications
Time interval between UBM device applications.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: