Clinical trial NCT02322554: Cellular and Tissue Based Therapy Registry
Official title: The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcers
Venous Stasis Ulcer
Pressure Ulcer
Chronic Non Healing Wound
Surgical Wound Dehiscence
Keywords: electronic health records
Qualified Clinical Data Registry
PQRS
quality reporting
cellular based products
bioengieered skin
USWR
Lead sponsor: U.S. Wound Registry
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen at participating hospital based outpatient wound centers to whom CTPs are applied

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients receiving cellular and tissue based products

Exclusion Criteria:

* none

Primary outcomes:
measure: Healing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: St. Luke's Wound Care Clinic
state: Texas
Study officials:
References: