CTPs

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The Importance of Clinical Trials

By Thomas E. Serena MD, FACS, FACHM, FAPWCA

I do not know the origin of the phrase "...a gift from the devil's grandmother." I first read it in Einstein's letters to Schrödinger. Einstein employed the phrase to describe his fear of failing to find a unified theory of relativity and quantum physics. The problem appeared unsolvable. A similar gift in the field of clinical trial research in wound healing appeared on my doorstep recently. I started my research career conducting double-blinded pharmaceutical trials. After a string of failures, I convinced myself that advanced therapy in chronic wounds was doomed; however, cellular- and/or tissue-based products (CTPs) entered the market with encouraging results, brightening my spirits. To date, our cooperative group of investigators has published more than a dozen trials demonstrating the efficacy of CTPs in the treatment of diabetic and venous ulcers.

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Temple University School of Podiatric Medicine's picture
Wound Care Journal Club Review

Twenty-five percent of all diabetic patients will develop a diabetic foot ulcer (DFU), the major reason for hospitalizations in diabetic patients. The current standard of care (SOC) for DFUs consists of debridement, glycemic control, antimicrobial therapy, and imaging. DFUs often become infected, and with improper healing they require more advanced care and possibly lower extremity amputation. This study evaluated the usefulness of a perfusion-decellularized porcine hepatic-derived wound matrix (PDPHD-WM) in treating difficult-to-heal ulcers, or DFUs of greater than three months’ duration that had been treated with at least one other advanced method.

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Marietta, GA – October 11, 2017 – MiMedx Group, Inc. (NASDAQ: MDXG), a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been published in the International Wound Journal.

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Temple University School of Podiatric Medicine's picture

Wounds with exposed bone and tendon are a major concern for physicians due to the significant morbidity that they can cause. The primary focus of this study is to determine the efficacy and safety of a biologically active, cryopreserved human skin allograft for the treatment of wounds of this nature.

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Silver Spring, MD – September 6th, 2017 – The final guidance, "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271," explains when it is necessary for manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), which do not require FDA premarket review and approval, to report to the agency when infectious disease testing or determination of other donor eligibility criteria have not been performed properly.

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Temple University School of Podiatric Medicine's picture
Wound Care Journal Club Review

One fourth of the approximately 22.3 million patients with diabetes in the United States are expected to develop a diabetic foot ulcer (DFU) at some point during their lives, and it is estimated to affect 1-8% of diabetics annually. DFUs have shown to be challenging to treat, and often result in extended hospital stays, increased risk of infection, and subsequent amputation in certain patients. A major concern regarding amputees is a 5-year mortality rate that rivals that of patients with colon cancer. In addition, DFUs contribute heavily to the financial load of payers, with an estimated annual medical cost of up to $13 billion.

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Temple University School of Podiatric Medicine's picture
Wound Care Journal Club Review

Chronic wounds and ulcerations induced by complications associated with diabetes mellitus have proven to be a burden to the patients themselves, as well as the healthcare system as a whole. This burden has required physicians to not only find interventions that work better, but are also more cost effective. In the population with diabetes, 1 out of 4 will have an ulceration of the lower extremity at some point in their life. It’s also important to state that these foot ulcers can lead to some form of amputation in 20% of these patients. Standard wound care typically involves moist dressings, debridement, wound offloading, infection control, and in some cases, advanced therapies. The authors of this study looked into two of these advanced therapies, bioengineered skin substitutes (BSS) and dehydrated human amnion/chorion membranes (dHACM.) The primary objective of the study was to see which worked best, as compared to standard wound care (SWC), while the secondary objective was to see which had the lowest costs.

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by The Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders played a key role in educating the FDA and its advisory panel on the role and real-world value of antimicrobial wound care dressings, as the FDA considered a regulatory classification of these products that could impact access and availability to wound care providers and patients.

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Thomas Serena's picture
value formula

by Thomas E. Serena MD, FACS, FACHM, FAPWCA

"Price is what you pay. Value is what you get"
-Warren Buffet1

Lawrence Mills introduced the concept of Value Analysis to the manufacturing industry a half century ago. The basic idea entails analyzing the function and importance of the various parts of a product as they relate to cost. He derived the following equation2:

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