Cellular and Tissue Based Therapy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Cardiology, Hospital, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/3/2018 |
| Start Date: | January 2005 |
| Contact: | Caroline E Fife, MD |
| Email: | cfife@uswoundregistry.com |
| Phone: | 800-603-7896 |
The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide
real world patient data from electronic health records submitted to meet Stage 2 Meaningful
Use in order to understand the value of these products among patients with chronic wounds and
ulcers. Randomized, controlled trials to establish product efficacy routinely exclude
patients with the co-morbid conditions common to patients seen in usual clinical practice and
thus the results of these RCTs tend to be non-generalizable. Little is known about the
effectiveness of CTPs among typical patients.
real world patient data from electronic health records submitted to meet Stage 2 Meaningful
Use in order to understand the value of these products among patients with chronic wounds and
ulcers. Randomized, controlled trials to establish product efficacy routinely exclude
patients with the co-morbid conditions common to patients seen in usual clinical practice and
thus the results of these RCTs tend to be non-generalizable. Little is known about the
effectiveness of CTPs among typical patients.
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide
comparative effectiveness data for patients with chronic wounds and ulcers and to understand
whether clinical practice guidelines are followed in the use of these products. These
products are referred to by a variety of names of which are inaccurate reflections of their
structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered
tissues," "biological dressings"). The preferred term is cellular and/or tissue based
products (CTPs). CTPs are utilized for their biological influence on the healing process by
stimulating or supporting healing. They may or may not be incorporated into regenerating
tissue. Both tissue derived and biosynthetic products may be made with or without dead cells
and biomaterials made of living cells may be comprised of autologous cells (cultured and not
cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The
diversity of products and the rate at which they are becoming available for clinical use make
it impossible to perform randomized controlled trials to compare their effectiveness against
one another. Effectiveness in real world patients is the best current option to understand
the role of CTPs in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to
provide data as part of quality initiatives and to meet their Stage 2 Meaningful use
criteria. The CTPR is a subset of the USWR data. All patient data from all participating
outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS
and other initiatives. Data used for effectiveness research is HIPAA de-identified. These
data are derived from structured language entries directly transmitted from electronic health
records which also link to billing and charge documents once practitioners sign and lock
charts, confirming the veracity of data entries.
comparative effectiveness data for patients with chronic wounds and ulcers and to understand
whether clinical practice guidelines are followed in the use of these products. These
products are referred to by a variety of names of which are inaccurate reflections of their
structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered
tissues," "biological dressings"). The preferred term is cellular and/or tissue based
products (CTPs). CTPs are utilized for their biological influence on the healing process by
stimulating or supporting healing. They may or may not be incorporated into regenerating
tissue. Both tissue derived and biosynthetic products may be made with or without dead cells
and biomaterials made of living cells may be comprised of autologous cells (cultured and not
cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The
diversity of products and the rate at which they are becoming available for clinical use make
it impossible to perform randomized controlled trials to compare their effectiveness against
one another. Effectiveness in real world patients is the best current option to understand
the role of CTPs in wound healing.
Hospital based outpatient wound centers participating in the US Wound Registry agree to
provide data as part of quality initiatives and to meet their Stage 2 Meaningful use
criteria. The CTPR is a subset of the USWR data. All patient data from all participating
outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS
and other initiatives. Data used for effectiveness research is HIPAA de-identified. These
data are derived from structured language entries directly transmitted from electronic health
records which also link to billing and charge documents once practitioners sign and lock
charts, confirming the veracity of data entries.
Inclusion Criteria:
- patients receiving cellular and tissue based products
Exclusion Criteria:
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