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Can a Bladder-Derived patch improve wound healing in daily practice?

NCT ID NCT07805798

Knowledge-focused Sponsor: Integra LifeSciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This registry study collects real-world data from about 300 adults treated with urinary bladder matrix (UBM) products for various wounds, including pressure ulcers, surgical incisions, and infections like Fournier's gangrene. Researchers track patient characteristics, treatment patterns, and outcomes such as complete wound closure and time to closure. The goal is to understand how UBM products perform in routine clinical care, where treatment decisions are made by the clinician, not the study protocol.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Urinary bladder matrix (UBM) wound management products
What this could lead to
If successful, this registry could clarify how well UBM products work in everyday practice, helping clinicians choose the best wound care approach.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may vary widely due to differences in patient care and wound types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer fournier gangrene hidradenitis suppurativa necrotizing soft tissue infection pilonidal sinus Surgical Wound

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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