Fournier's Gangrene, Hidradenitis Suppurativa (HS), Incisional, Lower Extremity Wound, Necrotizing Soft Tissue Infection, Open Abdomen, Pilonidal Cyst, Pressure Ulcer (PU), Soft Tissue Reconstruction, Tissue Repair, Wound Management
Conditions
Brief summary
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.
Interventions
DEVICEUrinary 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.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complete Wound Closure | Up to 12 months following the initial UBM application. | Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Wound Closure | Up to 12 months following the initial UBM application. | Time from the initial UBM application to documented complete wound closure. |
| Incidence of Treatment-Emergent Adverse Events | Up to 12 months following the initial UBM application. | 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. |
Outcome results
None listed