Clinical Research

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Clinical Research

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

I have conducted numerous unblinded clinical trials, mostly evaluating cellular or tissue-based Products (CTPs). These trials do not easily lend themselves to blinding. However, when I slated this topic with the title “Unblinding the Blind" for my Association for the Advancement of Wound Care lecture track at next year’s spring Symposium on Advanced Wound Care, the organizers removed it and cited the lecture’s controversial nature. I thought that scientific research was the last frontier of free-wheeling discourse in the private sector, but here lurks the most challenging aspect of contemporary research in wound care: we woundologists do not demand increasing rigor in our trials. Outside of hyperbaric oxygen (HBOT) studies, we have not critically evaluated trial results.

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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

Staphylococcus aureus is a primary cause of post-operative surgical site infection. S. aureus produces hyaluronidase, which degrades hyaluronic acid (HA). HA is important in wound healing because it prevents bacterial proliferation and provides anti-inflammatory properties. Although early bactericidal antibiotic treatment is important for wound infection, systemic antibiotics often do not prove to be entirely beneficial for wound penetration. Therefore, newer treatment methods that are not at risk of antibiotic resistance are necessary.

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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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Wound Care Clinical Trials

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

A recent article by Kaiser Health News misquoted me as saying that we enroll only "healthy" patients in our clinical trials. At moments like this, one feels that something has been overlooked. One of my research coordinators, recalling the serious adverse events (SAEs) of the previous week said, "The only patients sicker than ours are underground."

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Canton, MA – March 27, 2017 – Organogenesis Inc., a global leader in advanced wound care innovations and technologies, today announced the launch of a PuraPly™ Antimicrobial (PuraPly™ AM) clinical research program which will comprise multiple studies and a nationwide patient registry.

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clinical research in wound care

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

The ancients sacrificed a brown dog at the beginning of the Dog Days to appease the rage of Sirius, believing that the star was the cause of the hot, sultry weather. Why a brown dog? I wonder. I think it more appropriate to register a complaint with the concierge that the air conditioner in my room is acting strange and performing poorly. But the dog days of Summer 2016 are upon us with a menacing bark and a harsh bite. I am lethargic. I am uncomfortable. I wondered whether to blog or not.

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Providence, RI – August 19, 2016 – The Wound Healing Foundation (WHF), through the support of Medline Industries, is pleased to announce the creation of a new grant, the WHF Hyaluronic Acid Wound Healing Research Grant for the year 2016. This one-year $15,000 research grant is to stimulate research about hyaluronic acid in wound healing. Study proposals may include in vitro, in vivo, and/or clinical based studies. Interested candidates meeting the grant requirements should submit their proposals by September 19, 2016.

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wound care journal club

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.