Real-World Registry of Urinary Bladder Matrix
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Incidence of Complete Wound Closure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Urinary Bladder Matrix (UBM) Products (Device)
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.
干预措施: Urinary Bladder Matrix (UBM) Products (Device)
结局指标
主要结局
Incidence of Complete Wound Closure
时间窗: 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.
次要结局
- 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.)