Pressure Ulcer Clinical Trial
Official title:
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.
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.
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Status | Clinical Trial | Phase | |
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Completed |
NCT03351049 -
An RCT on Support Surfaces for Pressure Ulcer Prevention
|
N/A | |
Completed |
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Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
|
||
Completed |
NCT05575869 -
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
|
N/A | |
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Completed |
NCT04540822 -
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
|
N/A | |
Terminated |
NCT05234632 -
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
|
N/A | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Completed |
NCT01438541 -
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
|
Phase 4 | |
Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
Completed |
NCT04251897 -
Novel Support Surface to Alleviate Pressure Ulcer
|
N/A | |
Completed |
NCT03391310 -
Use of Honey for Pressure Ulcers in Critically Ill Children
|
N/A | |
Recruiting |
NCT04559165 -
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
|
N/A | |
Completed |
NCT05646121 -
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
|
||
Not yet recruiting |
NCT06421454 -
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
|
N/A | |
Terminated |
NCT05547191 -
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
|
N/A | |
Completed |
NCT05458050 -
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
|
N/A | |
Active, not recruiting |
NCT03048357 -
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
|
N/A | |
Completed |
NCT06025370 -
Pressures During Prone Positions in Healthy Volunteers
|
N/A | |
Recruiting |
NCT05033470 -
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
|
N/A |