Day 1 :
Serena Groups, USA
Time : 09:15-10:00
Thomas E Serena, Founder and Medical Director of SerenaGroup®, a family of wound, hyperbaric and research companies. Serena completed his residency in Surgery at the Hershey Medical Center. To date he has opened and operates wound care centers across the United Sates and globally. He has been the lead or Principal investigator in over 100 clinical trials and is recognized internationally as an expert in the field of wound healing: He has more than 100 published papers and has given more than 1000 invited lectures throughout the world. He has been a member of the Board of Directors of the Wound Healing Society and served two terms on the board of the Association for the Advancement of Wound Care (AAWC) and is now the President-Elect. He has also been Vice-President of the American College of Hyperbaric Medicine and President of the American Professional Wound Care Association.
Clinical research is an essential component of SerenaGroup’s ™ Center-of-Excellence model for wound and hyperbaric centers. We are one of the world’s leaders in clinical research on wound care and hyperbaric medicine, having conducted over 100 clinical trials involving growth factors, gene therapy, genomics, Cellular and Tissue Based products, and novel pharmaceuticals. In 2011 SerenaGroup™ clinics conducted the research that led to the first diagnostic in wound care; this diagnostic procedure was identified in the ensuing manuscript as the Serena Technique©. In conjunction with Harvard’s Wellman Institute we developed and performed the initial clinical studies on a painless, bedside epidermal skin-harvesting device that is functioning not only in hospitals in the US but in third-world clinics as well. We have filed numerous patents on novel products that were conceived in the clinics facing unmet needs, developed in our lab and returned to the clinic for clinical trials. Our emphasis on clinical research over the years has drawn a group of young clinicians and scientists who are dedicated to advancing the science of wound healing to participate in our research projects in the US and internationally. We formed the nation’s first wound healing cooperative group consisting of more than 30 centers in the US and worldwide that now conducts entire multinational clinical trials. In 2015 SerenaGroup Innovation™ opened a laboratory at Northeastern Ohio Medical School to conduct preclinical studies in wound healing. As a result of these efforts, our research team has filed numerous patents. Serena will review innovations in the field of wound care including therapies on the horizon, such as genomics and genetically modified products. He will review data from ongoing trials on indocyanine green fluorescent angiography and cellular-and-tissue-based products for wound care(CTP), examine advances in hyperbaric oxygen therapy, diagnostics and prognostics in wound care, present new pharmaceuticals on the horizon, and discuss the impact of quality measures on practice and reimbursement.
UT Health San Antonio, USA
Keynote: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTER STUDY COMPARING CONTINUOUS DIFFUSION OF OXYGEN THERAPY TO SHAM THERAPY IN THE TREATMENT OF DIABETIC FOOT ULCERS
Time : 10:00-10:45
Joel E Michalek completed his PhD from Wayne State University. He has a broad background in biostatistics pertaining to theory and methods, preclinical and clinical trials, and epidemiology. He has written protocols and grants, analyzed data, and co-authored manuscripts arising from clinical studies in surgery, emergency medicine, cancer, and pediatrics and were formerly Principal Investigator of the Air Force Health Study, a 20-year prospective epidemiological study of veterans who sprayed Agent Orange and other herbicides in Vietnam. He has authored 180 journal articles and two book chapters.
Background: Over the past generation, preclinical data have suggested that there is a potential physiologic benefit to applying oxygen topically to wounds. However, we are unaware of any studies in the literature that have robustly assessed whether this would lead to a higher proportion of healing in similarly treated people without oxygen. Therefore, the purpose of this study was to assess this in people being treated for diabetic foot ulcers (DFUs). Methods: We enrolled and randomized 100 subjects with DFUs (79% male, aged 58.3+/-12.1 years) to receive either active continuous diffusion of oxygen (CDO) therapy using an active CDO device, or an otherwise fully operational sham device that provided moist wound therapy (MWT) without delivering oxygen. Patients were followed until closure or 12 weeks, whichever was sooner. Patients, treating physicians and independent evaluators were blinded to the study arm. All patients received identical offloading, dressings and follow-up. Results: There were no significant differences in assessed descriptive characteristics between the treatment arms (p>0.05 for all). A significantly higher proportion of people healed in the active arm compared to sham (46% vs 22%, p=0.02). This relative effect became greater in more chronic wounds (42.5% vs 13.5%, p=0.006). The active arm experienced significantly faster rates of closure relative to the sham arm (p<0.001). Conclusions: The results of this study demonstrated that continuously diffused oxygen over a wound leads to significantly higher rates of closure, and faster time to closure, compared to similarly treated patients receiving good quality standard therapy coupled with a sham device. Furthermore, the relative efficacy appears to improve the more the therapy may be needed (more chronic and larger wounds).
Chang Gung University, Taiwan
Time : 11:15-12:00
Ching-Jen Wang, M.D. graduated from National Taiwan University, College of Medicine. He is a board certified orthopedic surgeon and currently holds a clinical faculty at Chang Gung University College of Medicine and serves as a consultant orthopedic surgeon of Kaohsiung Chang Gung Memorial hospital, Taiwan. He has published more than 236 papers in reputed journals and has been serving as the reviewer in man
The purpose of this investigation was to study the effectiveness of Extracorporeal Shockwave Therapy (ESWT) for the treatment of keloid scars, and compared the results with intra-lesional steroid injection. Thirty-nine patients were randomly divided into 22 in ESWT group and 17 in steroid group. The ESWT group received 3 ESWT treatments in 6 weeks. The steroid group received 3 intra-lesional triamcinolone injection in 6 weeks. The evaluations included gross morphology, functional outcome, local blood flow perfusion, biopsy for histopathological examination and immunohistochemical analysis. Both groups showed significant improvements in appearance with less discoloration, flatter and softer consistency and more elasticity of the lesions but unchanged size after treatment. Overall, there was no significant difference between two groups. Both groups showed comparable functional scores, POSAS patient and observer scales. The blood flow perfusion rates were statistically not significant between two groups before and after treatments. Histopathological findings revealed no significant difference in cell count, cell activity and cell concentration between two groups. After ESWT significant decreases in collagen type I, type III and Masson Trichrome stain were observed after ESWT as compared to steroid group. However, very little changes were noticed in angiogenesis, inflammatory cytokines, tissue proliferating and apoptosis, and no statistical significance was noticed between two groups before and after treatment. This study revealed that ESWT showed comparable functional outcome, POSAS patient and observer scales as compared to steroid injection for keloid scars. Treatment of keloid scars with ESWT resulted in significant decreases in collagen fibers and increases in MMP-13 enzyme.