Urinary Bladder Matrix (UBM) Registry

N/ANot Yet RecruitingNCT07805798

Integra LifeSciences Corporation300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Tissue Repair Soft Tissue Reconstruction Wound Management Pressure Ulcer (PU)Necrotizing Soft Tissue Infection Fournier's Gangrene Pilonidal Cyst Open Abdomen

Interventions

Urinary Bladder Matrix (UBM) ProductsDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria * Adults aged ≥21 years at the time of initial urinary bladder matrix (UBM) product application. * Received or are receiving an eligible UBM product for treatment of a qualifying wound, including: Pressure ulcer (Stage III/IV) 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) * 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. Exclusion Criteria * 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. * 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.

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.

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

Secondary Outcomes

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.

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.