Cellular and Tissue Based Therapy Registry (CTPR)

April 30, 2018 updated by: U.S. Wound Registry

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients seen at participating hospital based outpatient wound centers to whom CTPs are applied

Description

Inclusion Criteria:

  • patients receiving cellular and tissue based products

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
wounds treated with CTPs
All cellular and tissue based products currently reimbursed in the hospital based outpatient department, administered at intervals as determined in the course of clinical practice
Biological: Cellular and tissue based products
Procedure: Application of device or biological to wounds
Other Names:
  • Alloderm
  • Integra
  • Apligraf
  • Dermagraft
  • Epifix
  • Oasis
  • Talymed
  • Primatrix
  • Theraskin
  • Grafix
  • Dermaspan
  • Amnioband
  • GraftJacket
  • Matristem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 12 months
Healing or wound closure by wound type and stratified by Wound Healing Index
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Wound Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2005

Primary Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

November 23, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (ESTIMATE)

December 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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