An observational study in Tissue Repair, Soft Tissue Reconstruction and Wound Management, sponsored by Integra LifeSciences Corporation. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Integra LifeSciences Corporation · Observational
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 300 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Incidence of Complete Wound Closure
Proportion of wounds achieving complete wound closure as documented in the medical record during routine clinical care.
Time frame: Up to 12 months following the initial UBM application.
Time to Complete Wound Closure
Time from the initial UBM application to documented complete wound closure.
Time frame: 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.
Time frame: Up to 12 months following the initial UBM application.
Wound Area or Volume Reduction Over Time
Time frame: Up to 12 months.
Percentage of Skin Graft Take
Percentage of skin graft take at first dressing take-down and/or patient discharge, if available.
Time frame: Up to 12 months.
Number of UBM Applications
Number of UBM device applications during the treatment period.
Time frame: Up to 12 months.
Time Between UBM Applications
Time interval between UBM device applications.
Time frame: Up to 12 months.
Pain Medication Utilization
Prescription of pain medications, including morphine equivalents and GABA-modulating agents.
Time frame: Up to 12 months.
Length of Hospital Stay
Duration of hospitalization associated with wound treatment.
Time frame: Up to 12 months.
Resting Pain Intensity
Resting pain intensity measured on a 0-10 Numeric Rating Scale (NRS).
Time frame: Months 3, 6, and 12
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Integra LifeSciences Corporation →