Tissue RepairNCT07805798
Urinary Bladder Matrix (UBM) Registry
An observational study of Tissue Repair and Soft Tissue Reconstruction, run by Integra LifeSciences Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tissue Repair, Soft Tissue Reconstruction, Wound Management
- What is being tested?
- Urinary Bladder Matrix (UBM) Products
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 31 Dec 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Real-World Registry of Urinary Bladder Matrix
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
- Being tested
- Urinary Bladder Matrix (UBM) Products
- Medical subject headings
- Pressure Ulcer, Fournier Gangrene, Pilonidal Sinus, Hidradenitis Suppurativa, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Urinary Bladder Matrix (UBM) Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complete Wound Closure
Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care.
Measured: Up to 12 months following the initial UBM application.
Secondary outcomes (2)
Time to Complete Wound Closure
Time from the initial UBM application to documented complete wound closure.
Measured: 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.
Measured: Up to 12 months following the initial UBM application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805798
- Sponsor's protocol ID
- T-UBMREG-001
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Registry of Urinary Bladder Matrix
- ClinicalTrials.gov ID
- NCT07805798
- Acronym / sponsor ID
- T-UBMREG-001
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU), Necrotizing Soft Tissue Infection, Fournier's Gangrene
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Device: Urinary Bladder Matrix (UBM) ProductsPatients 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. |
| Prospective Cohort | – | Device: Urinary Bladder Matrix (UBM) ProductsPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary Bladder Matrix (UBM) ProductsCommercially 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. | Device | Prospective Cohort, Retrospective Cohort |
Primary outcome
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.
2 secondary outcomes
Time to Complete Wound Closure
Time frame: Up to 12 months following the initial UBM application.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 12 months following the initial UBM application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Repair and Soft Tissue Reconstruction, run by Integra LifeSciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complete Wound Closure (time frame: Up to 12 months following the initial UBM application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.