Urinary Bladder Matrix (UBM) Registry

NCT07805798 | Not Yet Recruiting FDA Device

• 1 other identifier: T-UBMREG-001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tissue Repair; Soft Tissue Reconstruction; Wound Management; Pressure Ulcer (PU); Necrotizing Soft Tissue Infection; Fournier's Gangrene; Pilonidal Cyst; Open Abdomen; Hidradenitis Suppurativa (HS); Lower Extremity Wound; Incisional

Outcome Measures

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.

  Up to 12 months following the initial UBM application.

Secondary Outcomes (2)

• Time to Complete Wound Closure

  Up to 12 months following the initial UBM application.

• Incidence of Treatment-Emergent Adverse Events

  Up to 12 months following the initial UBM application.

Other Outcomes (7)

• Wound Area or Volume Reduction Over Time

  Up to 12 months.

• Percentage of Skin Graft Take

  Up to 12 months.

• Number of UBM Applications

  Up to 12 months.

Study Arms (2)

Retrospective Cohort

Patients with qualifying wounds previously treated with an eligible UBM product whose clinical data are collected through abstraction of existing medical records. No study-specific interventions, procedures, or follow-up visits are required. Participants are enrolled under an IRB-approved waiver of informed consent, where applicable.

Device: Urinary Bladder Matrix (UBM) Products

Prospective Cohort

Patients receiving treatment with an eligible UBM product for a qualifying wound who provide informed consent and are followed through routine standard-of-care clinical visits. Clinical data are collected prospectively from the medical record without protocol-mandated interventions or visits.

Device: Urinary Bladder Matrix (UBM) Products

Interventions

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.

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

MeSH Terms

Conditions

Pressure Ulcer; Fournier Gangrene; Pilonidal Sinus; Hidradenitis Suppurativa; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Cysts; Neoplasms; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09