Clinical Trials

by Margaret Heale RN, MSc, CWOCN

When looking at randomized controlled trials one of the first things you read is a one liner, "subjects were matched," and there may be a list that includes stage of pressure injury, size of wound, age, sex, and a myriad of other things somebody decided to include. There may also be exclusion criteria such as uncontrolled blood sugar, obesity, and being over 60 years old. It makes sense to do this, and there is no doubt that once you have got homogenous groups and compare the outcome of one with another, after whatever intervention you wish to discover the worth of, the result may look gratifyingly convincing.

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.

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."

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.

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

Recently, I had the pleasure of attending Puccini's opera Turandot at New York's Metropolitan Opera House. In my favorite scene, young prince Calef comes upon a gruesome tableau: Potential suiters for the princess Turnadot must answer three questions correctly in order to win her hand. On the downside, one incorrect answer is rewarded with a beheading. Calef takes the challenge and answers all three questions flawlessly. Yet, the princess begs her father not to force her to marry the stranger. Calef intercedes saying that if she can guess his name before dawn he will release her from her obligation. Confident of conquest, he sings Nessun dorma (none shall sleep), the opera's most famous aria.

by Michel H.E. Hermans, MD

At the beginning of a new year, many look back at the previous one in an attempt to analyze what happened, whether it was good or bad or perhaps even special.

From a chronic or acute wound healing point of view, 2015 was not particularly special. Yes, a number of new dressings and techniques were launched at the different conferences, but none of them really established a breakthrough with regard to new clinical data or a totally new approach to many of the still unsolved problems that exist in healing wounds.

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.

Temple University School of Podiatric Medicine Journal Review Club

Article title: Treatment with LL-37 is safe and effective in enhancing healing of hard-to-heal venous leg ulcers: a randomized placebo controlled clinical trial.
Authors: Alvar Gronberg, DrMedSc; Margit Mahlapuu, PhD; Mona Stahle, MD, PhD; Caroine Whately-Smith, CStat; Ola Rollman, MD, PhD.
Journal name and issue: Wound Repair and Regeneration, September-October 2014 (pages 613-621).
Reviewed by: Lucy Barrow, Temple University School of Podiatric Medicine

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

Pete Seeger died a year ago last January at the age of 94. Reading a tribute to the folk singer, I ran across his most memorable tune, "Where have all the flowers gone?" I have long enjoyed the numerous versions of this folk song recorded by dozens of artists. The fatalism of the lyrics and the circular verse form made it emblematic of a most unfortunate decade in American life: the 60s.

by Michel H.E. Hermans, MD

Merriam Webster defines bias as "selecting or encouraging one outcome or answer over others." The Cochrane handbook states: "The reliability of the results of a randomized trial depends on the extent to which potential sources of bias have been avoided."

When designing a trial or even animal research, avoiding bias is difficult. In fact, it may be introduced unknowingly or deliberately.