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D O Nicholas Sousa, D O Rahil Dharia, D O Shilpin Mehta, D O Keith Marshall, D O David Siegel
Leak following laparoscopic sleeve gastrectomy is one of the most feared complications and its management can be difficult and frustrating for patients and physicians involved. Using multimodality approach and having variable options to plan management for patients presenting with leak following bariatric surgery can be advantageous for physicians. The use of endoscopic injection of EpiFix-dehydrated Human Amnion/Chorion Membrane (dHACM) allograft can be a novel adjunct in facilitating healing of the leak site by iatrogenic introduction of tissue growth factors, cytokines and building connective tissue matrix...
September 2017: Journal of Surgical Case Reports
Christian Bianchi, Shawn Cazzell, Dean Vayser, Alexander M Reyzelman, Hasan Dosluoglu, Gregory Tovmassian
A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non-healing full-thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing...
February 2018: International Wound Journal
Edward P Miranda, Alex Friedman
Objective: Ulceration of free flaps in patients with venous insufficiency and/or lymphedema is an uncommon but challenging problem. We hypothesized that dehydrated human amnion/chorion membrane (Epifix) grafts would accelerate healing of these challenging ulcers. Methods: Retrospective analysis of prospectively acquired data identified 8 lower extremity free flaps with ulcerations in the context of venous insufficiency and/or lymphedema. The first 4 were flaps that had been treated with conservative wound care to healing...
2016: Eplasty
Trientje B Santema, Paul P C Poyck, Dirk T Ubbink
BACKGROUND: Foot ulceration is a major problem in people with diabetes and is the leading cause of hospitalisation and limb amputations. Skin grafts and tissue replacements can be used to reconstruct skin defects for people with diabetic foot ulcers in addition to providing them with standard care. Skin substitutes can consist of bioengineered or artificial skin, autografts (taken from the patient), allografts (taken from another person) or xenografts (taken from animals). OBJECTIVES: To determine the benefits and harms of skin grafting and tissue replacement for treating foot ulcers in people with diabetes...
February 11, 2016: Cochrane Database of Systematic Reviews
Michelle Massee, Kathryn Chinn, Jeremy J Lim, Lisa Godwin, Conan S Young, Thomas J Koob
Objective: Human amniotic membranes have been shown to be effective for healing diabetic foot ulcers clinically and to regulate stem cell activity in vitro and in vivo; however, diabetic stem cells may be impaired as a sequela of the disease. In this study, dehydrated human amnion/chorion membrane (dHACM) allografts (EpiFix(®); MiMedx Group) were evaluated for their ability to regulate diabetic stem cells in vitro. Approach: Human adipose-derived stem cells (ADSCs) from normal, type I diabetic, and type II diabetic donors were treated with soluble extracts of dHACM and evaluated for proliferation after 3 days by DNA assay, chemotactic migration after 1 day by transwell assay, cytokine secretion after 3 days by multiplex ELISA, and gene expression after 5 days by reverse transcription-polymerase chain reaction...
February 1, 2016: Advances in Wound Care
Michelle Massee, Kathryn Chinn, Jennifer Lei, Jeremy J Lim, Conan S Young, Thomas J Koob
Human-derived placental tissues have been shown in randomized clinical trials to be effective for healing chronic wounds, and have also demonstrated the ability to recruit stem cells to the wound site in vitro and in vivo. In this study, PURION(®) Processed dehydrated human amnion/chorion membrane allografts (dHACM, EpiFix(®) , MiMedx Group, Marietta, GA) were evaluated for their ability to alter stem cell activity in vitro. Human bone marrow mesenchymal stem cells (BM-MSCs), adipose derived stem cells (ADSCs), and hematopoietic stem cells (HSCs) were treated with soluble extracts of dHACM tissue, and were evaluated for cellular proliferation, migration, and cytokine secretion...
October 2016: Journal of Biomedical Materials Research. Part B, Applied Biomaterials
H Penny, M Rifkah, A Weaver, P Zaki, A Young, G Meloy, R Flores
UNLABELLED: Diabetic foot ulcers (DFUs) occur as a result of multifactorial complications and are commonly found in the diabetic community. Underlying disease states such as neuropathy and peripheral vascular disease can slow healing rates, potentially leading to recurrence, amputation, and increased mortality. As with many other disease processes, DFUs have several treatment options, such as debriding agents, alginate seaweed extract, hydrocolloid gels, and amniotic membrane allografts...
March 2015: Journal of Wound Care
Charles M Zelen, Lisa Gould, Thomas E Serena, Marissa J Carter, Jennifer Keller, William W Li
A prospective, randomised, controlled, parallel group, multi-centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx Group, Inc., Marietta, GA), or standard wound care with collagen-alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or EpiFix used...
December 2015: International Wound Journal
Thomas E Serena, Marissa J Carter, Lam T Le, Matthew J Sabo, Daniel T DiMarco
Venous leg ulcers produce significant clinical and economic burdens on society and often require advanced wound therapy. The purpose of this multicenter, randomized, controlled study is to evaluate the safety and efficacy of one or two applications of dehydrated human amnion/chorion membrane allograft and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. The primary study outcome was the proportion of patients achieving 40% wound closure at 4 weeks...
November 2014: Wound Repair and Regeneration
Thomas J Koob, Jeremy J Lim, Michelle Massee, Nicole Zabek, Robert Rennert, Geoffrey Gurtner, William W Li
BACKGROUND: Chronic wounds are associated with a number of deficiencies in critical wound healing processes, including growth factor signaling and neovascularization. Human-derived placental tissues are rich in regenerative cytokines and have been shown in randomized clinical trials to be effective for healing chronic wounds. In this study, PURION® Processed (MiMedx Group, Marietta, GA) dehydrated human amnion/chorion membrane tissue allografts (dHACM, EpiFix®, MiMedx) were evaluated for properties to support wound angiogenesis...
2014: Vascular Cell
Thomas J Koob, Robert Rennert, Nicole Zabek, Michelle Massee, Jeremy J Lim, Johnna S Temenoff, William W Li, Geoffrey Gurtner
Human amnion/chorion tissue derived from the placenta is rich in cytokines and growth factors known to promote wound healing; however, preservation of the biological activities of therapeutic allografts during processing remains a challenge. In this study, PURION® (MiMedx, Marietta, GA) processed dehydrated human amnion/chorion tissue allografts (dHACM, EpiFix®, MiMedx) were evaluated for the presence of growth factors, interleukins (ILs) and tissue inhibitors of metalloproteinases (TIMPs). Enzyme-linked immunosorbent assays (ELISA) were performed on samples of dHACM and showed quantifiable levels of the following growth factors: platelet-derived growth factor-AA (PDGF-AA), PDGF-BB, transforming growth factor α (TGFα), TGFβ1, basic fibroblast growth factor (bFGF), epidermal growth factor (EGF), placental growth factor (PLGF) and granulocyte colony-stimulating factor (GCSF)...
October 2013: International Wound Journal
Charles M Zelen, Thomas E Serena, Guilhem Denoziere, Donald E Fetterolf
Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated...
October 2013: International Wound Journal
Emran S Sheikh, Ednan S Sheikh, Donald E Fetterolf
Non healing wounds present a significant social and economic burden. Chronic non healing wounds are estimated to affect as many as 1-2% of individuals during their lifetime, and account for billions of dollars of expense annually on both a national and global basis. Our purpose is to describe the use of a novel dehydrated amniotic membrane allograft (EpiFix(®) ; MiMedx Group, Inc., Kennesaw, GA) for the treatment of chronic non healing wounds. We describe the results of EpiFix treatment in four patients who had not achieved wound closure with both conservative and advanced measures, and had been referred for a definitive plastic surgery procedure...
December 2014: International Wound Journal
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