Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07805798

Urinary Bladder Matrix (UBM) Registry

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tissue Repair Bacterial Infections Bacterial Infections and Mycoses Cysts Fournier Gangrene Fournier's Gangrene Genital Diseases Genital Diseases, Male Hidradenitis Hidradenitis Suppurativa Hidradenitis Suppurativa (HS) Incisional Infections Lower Extremity Wound Male Urogenital Diseases Necrotizing Soft Tissue Infection Neoplasms Open Abdomen Pilonidal Cyst Pilonidal Sinus Pressure Ulcer Pressure Ulcer (PU) Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin Ulcer Skin and Connective Tissue Diseases Soft Tissue Reconstruction Suppuration Surgical Wound Sweat Gland Diseases Urogenital Diseases Wound Management Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Complete Wound Closure

    Time frame: 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 outcomes

  1. Time to Complete Wound Closure

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

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

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 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.

Other outcomes

  1. Wound Area or Volume Reduction Over Time

    Time frame: Up to 12 months.

  2. Percentage of Skin Graft Take

    Time frame: Up to 12 months.

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

  3. Number of UBM Applications

    Time frame: Up to 12 months.

    Number of UBM device applications during the treatment period.

  4. Time Between UBM Applications

    Time frame: Up to 12 months.

    Time interval between UBM device applications.

  5. Pain Medication Utilization

    Time frame: Up to 12 months.

    Prescription of pain medications, including morphine equivalents and GABA-modulating agents.

  6. Length of Hospital Stay

    Time frame: Up to 12 months.

    Duration of hospitalization associated with wound treatment.

  7. Resting Pain Intensity

    Time frame: Months 3, 6, and 12

    Resting pain intensity measured on a 0-10 Numeric Rating Scale (NRS).

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

Real-World Registry of Urinary Bladder Matrix

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.