Urinary Bladder Matrix (UBM) Registry

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorIntegra LifeSciences Corporation

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Urinary Bladder Matrix (UBM) Products

    Device

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Retrospective Cohort1 intervention
Group B: Prospective Cohort1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Complete Wound Closure

Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care.

Time frame
Up to 12 months following the initial UBM application.

Secondary outcomes

1

Time to Complete Wound Closure

Time from the initial UBM application to documented complete wound closure.

Time frame
Up to 12 months following the initial UBM application.
2

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.

Time frame
Up to 12 months following the initial UBM application.

Other outcomes

1

Wound Area or Volume Reduction Over Time

Time frame
Up to 12 months.
2

Percentage of Skin Graft Take

Percentage of skin graft take at first dressing take-down and/or patient discharge, if available.

Time frame
Up to 12 months.
3

Number of UBM Applications

Number of UBM device applications during the treatment period.

Time frame
Up to 12 months.
4

Time Between UBM Applications

Time interval between UBM device applications.

Time frame
Up to 12 months.

Locations

This trial has no locations.

Sponsors and contacts

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