Month: May 2018

Efficacy of a New Flowable Wound Matrix in Tunneled

and Cavity Ulcers: A Preliminary Report

 

Abstract: Introduction. In chronic wounds the healing is stagnant, and regenerative surgery is often needed. Many engineered tissues with a conventional bidimensional sheet are ineffective for tunneling wounds, because adherence to the wound bed is not complete. An advanced wound matrix for treating wounds with irregular geometries has been developed (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ).

 

Methods and Materials. Between March 2013 and December 2013 the authors treated 18 patients (11 female) with tunneled or cavity ulcers with the advanced wound matrix at the Unit of General and Geriatric Surgery of the Second University of Naples, Naples, Italy. Two patients (11.1%) had postsurgical wounds, two (11.1%) had post-traumatic wounds, and 14 (77.8%) had neuropathic ulcers. After debridement and antibiotic therapy, the lesions were filled with the wound matrix product. Surgical wound edges were either approximated with stitches or left to heal by secondary intention and covered with wet gauze. During the first week, follow-up visits were carried out every 3 days, then once a week until complete healing was achieved. All patients underwent preoperative and postoperative ultrasonography scans and plain radiograph controls. Results. Twenty-one applications were performed. Engraftment was complete in all but 1 patient who had diabetes and graft failure. Three patients needed repeated applications to complete the filling of the lesions. Median (range) pain Visual Analog Scores—on a scale of 0 to 10, where 0 = no pain, and 10 = intolerable pain—were 6.3 (range 3-8) preoperatively and 0.5 (range 0-2) at first follow-up (P ≤ 0.001). All but 2 patients showed a progressive remodeling of the tissue gap at scheduled radiographic controls. Conclusions. To the author’s knowledge, the advanced wound matrix used in this study is the only available biomaterial for the treatment of tunneled lesions. It stimulates tissue regeneration by filling surfaces which cannot be repaired spontaneously or by using conventional biomaterials in the form of sheets. Its application is atraumatic, painless, and safe … read more

Wound Care Nets Reimbursement “Wins” With Bipartisan Budget Act

The signing of the Bipartisan Budget Act of 2018 that took place Feb. 9 received much in the way of national media coverage because it ended the United States’ governmental shutdown. However, the act also provided the wound care industry some “wins” that were not well publicized. This article will focus on the major “wins” that pertain to wound care professionals who work in outpatient provider-based departments (PBDs) as well as various other sites of care and payment models.

 

REMOVED “DIRECT SUPERVISION” IN CRITICAL ACCESS PBDs

 

Hospital-based outpatient wound care PBDs are required to have direct physician supervision when Medicare beneficiaries are receiving therapeutic services. However, these same departments that are housed in critical access hospitals (CAHs) were exempt from the direct supervision requirement until 2014, when the Centers for Medicare & Medicaid Services (CMS) announced that it was going to enforce the direct-supervision requirement for CAHs. At that time, Congress stepped in and prevented CMS from enforcing the direct-supervision requirements for 2014, 2015, and 2016. However, Congress did allow CMS to enforce direct supervision in CAHs effective Jan. 1, 2017. That new requirement surprised many and caught staff members in the CAH space off guard, especially among those who did not have the availability of physicians or other qualified healthcare professionals who could be immediately available when patients were receiving care in the PBDs … read more

Peripheral arterial disease and the diabetic foot

Miranda Tawfik

Peripheral arterial disease (PAD) is a term used to describe atherosclerotic vessels in the periphery, mostly affecting the lower extremities. The blocked vessels impair blood and oxygen perfusion to the lower limbs and may lead to increased risk of ulceration, wounds and amputations. PAD is also associated with increased risk of coronary and cerebrovascular incidents. More than 50% of people living with PAD may not have any clinical symptoms, posing a challenge to diagnosis and management. This article will discuss the aetiology, presentation, risk factors, and management of PAD as related to the lower extremities … read more

How to Assess Wounds for Tunneling and Undermining

by Laurie Swezey RN, BSN, CWOCN, CWS, FACCWS

As part of a thorough wound assessment, in addition to noting location and measuring size, the entire wound bed should be probed for the presence of tunneling and/or undermining. If you are unsure what tunneling and undermining are and how to recognize these phenomena, here’s an explanation of these terms and how to assess wounds for their presence.

Tunneling Wounds

Tunneling is caused by destruction of the fascial planes which results in a narrow passageway. Tunneling results in dead space that has the potential for abscess formation. To measure tunneling, a probe is gently inserted into the passageway until resistance is felt. The distance from the tip of the probe to the point at which the probe is level with the wound edge represents the depth of the tunnel. Clock terms are often used to describe the position of the tunnel within the wound bed. This is helpful in identifying and remeasuring tunnel depth at a later time in order to assess progress of wound healing. Tunneling can occur in any wound, but it occurs most commonly in surgical wounds and wounds occurring from a neuropathic cause … read more

HIPAA calls it: Phone theft costs $650,000

Federal regulators lowered the boom on the former owner of several nursing homes after an iPhone containing the medical records of more than 400 residents was stolen.

 

Catholic Health Care Services of the Archdiocese of Philadelphia will pay $650,000 under settlement terms that also stipulate extensive self-analyses, documentation and improvement plans for patient record policies and practices … read more

Acellular Flowable Matrix in the Treatment of Tunneled or

     Cavity Ulcers in Diabetic Feet: A Preliminary Report

 

Campitiello, Ferdinando, MD; Mancone, Manfredi, PhD, MD; Della Corte, Angela, PhD, MD; Guerniero, Raffaella, MD; Canonico, Silvestro, MD

doi: 10.1097/01.ASW.0000531350.08738.34

 

OBJECTIVE: The authors aimed to explore the feasibility and safety of an advanced, acellular, flowable wound matrix (FWM) in patients with diabetes-related cavity or tunnel lesions involving deep structures.

 

METHODS: Patients with diabetic foot ulcers were hospitalized at the General and Geriatric Surgery Unit of the University of Campania in Naples, Italy, between March 2015 and December 2015. Twenty-three patients with tunneled or cavity ulcers were treated. The lesions were filled with the FWM. Surgical wound edges were either approximated with stitches or left to heal by secondary intention.

 

MAIN RESULTS: After 6 weeks, 78.26% of patients completely healed after a single application of the FWM. The healing time for all healed wounds was 30.85 ± 12.62 days, or 26.11 ± 5.43 days in patients for whom wound edges were approximated by stitches, and 57.66 ± 3.05 days in the patients who healed by secondary intention (P= .01). Permanent tissue regeneration was observed in a high percentage of patients, and shorter healing time was achieved. Study authors observed a low rate of complications such as major amputation and increased hospitalization.

 

CONCLUSIONS: The FWM seems ideal for tunneled and cavity ulcers with irregular geometry. This new porous matrix allows closure of the lesion while reducing healing time and demolition surgery … read more (purchase required)

IMR team receives prestigious award for wound healing with maggots

KUALA LUMPUR: A research team from the Institute of Medical Research (IMR) that made a breakthrough in wound healing with the use of maggots has been conferred the Dr Lee Jong-Wook Memorial Prize for Public Health at the 71st World Health Assembly (WHA).

 

The World Health Organisation (WHO) in Geneva, Switzerland made the announcement on Friday (May 25), said Health director-general Datuk Dr Noor Hisham Abdullah.

 

The WHA president conferred the prize to lead researcher Dr Nazni Wasi Ahmad, from the IMR, for her exemplary contributions in Maggot Debridement Therapy (MDT).

 

It is a type of biotherapy using live, sterile fly larvae or maggots in non-healing wound of a human or animal to remove dead cells and reduce bacterial contamination of the wound and stimulate healing, he said.

 

“It is a safe, effective and affordable alternative treatment that is available at any time and in any healthcare setting, mainly primary healthcare facilities, to treat diabetic foot ulcers.” said Dr Noor Hisham in a statement

Read more at https://www.thestar.com.my/news/nation/2018/05/25/imr-team-receives-prestigious-award-for-wound-healing-with-maggots/#OPMgFDYuWe9IzjPL.99

Wound Debridement Options

     The 5 Major Methods

 

There are five types of non-selective and selective debridement methods, but many factors determine what method will be most effective for your patient.1 Determining the debridement method is based not only on the wound presentation and evaluation, but also on the patient’s history and physical examination. Looking at the “whole patient, not only the hole in the patient,” is a valuable quote to live by as a wound care clinician. Ask yourself or your patient these few questions: Has the patient had a previous chronic wound history? Is your patient compliant with the plan of care? Who will be performing the dressing changes? Are there economic factors that affect the treatment plan? Take the answers to these questions into consideration when deciding on debridement methods.

 

The Primary Methods of Debridement: BEAMS
BEAMS is an mnemonic that is widely used to remember the five types of wound debridement … read more

 

NPUAP Announces Release of Educational Tools for Wound Care Providers

PRESS CONTACT: Liz Posner, lposner@douglasgould.com, 646-214-0514, ext. 3

 

Washington, D.C. – June 15, 2017 – The National Pressure Ulcer Advisory Panel (NPUAP) announced bundle pricing of the new digital slide sets, designed to assist in the continuing education of health care professionals to prevent and treat pressure injuries.

 

Wound care providers working in acute care, post-acute care, home care agencies, and schools of nursing will benefit from the use of the slide sets. They include the 2016 Pressure Injury Staging System Teaching Slide Set and the Prevention of Pressure Injuries Slide Set, both available for $75 each, and the Treatment of Pressure Injuries Slide Set, available for $90. Buy all 3 for $199- a savings of over $40! All are instantly downloadable in PDF format at the NPUAP online store.

 

The Pressure Injury Staging System Teaching Slide Set is the result of the NPUAP 2016 Staging Consensus Conference. The Prevention of Pressure Injuries Slide Set and the Treatment of Pressure Injuries Slide Setare based on the current International Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline.

 

“The primary mission of the NPUAP is to improve patient outcomes in pressure injury prevention and treatment,” said NPUAP President Mary Litchford, PhD, RDN, LDN. “By incorporating the latest scientific evidence into the educational slide sets for teaching health care providers, the NPUAP is supporting its patient-focused mission.”

 

Wound care providers can find a number of other resources available on the NPUAP online store, including webinar recordings, books, and high-resolution photographs of sample wounds for educational purposes.

 

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About the National Pressure Ulcer Advisory Panel

The National Pressure Ulcer Advisory Panel (NPUAP) is the nation’s leading scientific expert on pressure injury prevention and treatment. Our goal is to insure improved patient health and to advance public policy, education, and research.

WoundRounds® Launches New Mobile App for Wound Management

 

Schaumburg, Illinois (For Release Aug, 29, 2016) –WoundRounds®, the leading wound management solution, has announced their comprehensive wound documentation system is now available as a mobile app. The mobile app is available for WoundRounds clients on the Apple App Store.

 

“Adoption of mobile devices and applications has accelerated in recent years,” says Mike Diamond, CEO of Telemedicine Solutions, makers of WoundRounds. “The WoundRounds mobile app allows healthcare facilities to expand use of the WoundRounds solution to Apple mobile devices, leading to enhanced clinical outcomes and staff efficiencies.”

 

Data security is a growing concern for healthcare workers’ mobile devices, in light of a recent health system’s fines for HIPAA violations resulting from the theft of a staff member’s mobile phone. Diamond states, “The WoundRounds app works with the facility’s mobile device management (MDM) tools and meets strict security requirements to safeguard protected health information … read more

Creating an Ideal Microenvironment for Wound Cleansing

[Sponsored by Angelini Pharma, Inc.]

 

With so much focus on dressing choices, it’s easy to forget the importance of wound cleansing. Wound cleansing can help achieve the goals of wound bed preparation by removing microorganisms, biological and environmental debris to create an environment beneficial to healing as well as facilitating wound assessment by allowing clear visualization of the wound.

read more (registration required)

Diabetic Foot Ulcer Prevention System (DFUPS)

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers … read more

NATROX® Symposium at EWMA 2018

Inotec AMD hosted a well-attended symposium at the 2018 EWMA Conference in Krakow (Poland).

 

The Symposium focused on the vital role of oxygen in chronic wound healing and the importance of the Inotec’s NATROX® Oxygen Wound Therapy supported by three key speakers of the calibre of Paul Hayes, Hanna Kaufman and Thomas Serena.

 

Paul Hayes, vascular surgeon from the UK, discussed the role of topical oxygen in wound healing presenting the latest evidence on the matter. Hanna Kaufman, orthopaedic surgeon from Israel, shared the intriguing results of her 99-patient NATROX® study on non-healing wounds. Thomas Serena, founder and medical director of SerenaGroup in the US, explored the future of oxygen wound therapy.

 

NATROX® Oxygen Wound Therapy is an innovative, simple and easy-to-use device that has been clinically proven to deliver 98% pure humidified oxygen direct to the wound bed.

post from Natrox Oxygen Wound Therapy

Nutrition can aid in healing diabetic foot ulcers

In this issue, Susan Weiner, MS, RDN, CDE, CDN, talks with nutrition and wound care expert Nancy Collins, PhD, RDN, LD, NWCC, FAND, about the role of nutrition in prevention and treatment of diabetic foot ulcers. Nutrition is a critical component of healing diabetic foot ulcers, particularly as it relates to immune function, malnutrition, glycemic control, and weight loss and weight maintenance. Diabetes educators should include nutrition assessment and intervention as key components of the overall diabetes treatment plan to help patients with diabetic foot ulcers maximize their nutritional status and promote wound healing.

 

Nutrition is not often the first thing clinicians think of when dealing with diabetic foot ulcers. How important is it, and exactly what role does nutrition play?

 

Collins: Nutrition does indeed play an important role in the prevention and treatment of diabetic foot ulcers. A poor diet can result in altered immune function, malnutrition and poor glycemic control, all of which are risk factors for poor healing. Malnutrition and nutrient deficiencies can impair collagen synthesis, prolong inflammation, decrease phagocytosis causing dysfunction of B and T cells, and decrease the mechanical strength of the skin. Once a patient has a wound, achieving and maintaining a healthy body weight can help maximize wound healing because obesity can negatively affect glycemic control. Often just losing extra weight can help with glucose control and, in turn, wound healing. Of course, weight loss proves very challenging for most patients. This is where referral to a registered dietitian nutritionist with expertise in diabetes can help … read more

Under the Off-Load: A Pilot Case Series to Identify Ideal Dressings

     to use under Total Contact Casts (TCC)

 

Introduction: It is well stated in the literature that Total Contact Casting (TCC) is a standard of care for off-loading of neuropathic ulcers of the plantar surface. Another standard of care is to provide a moist wound healing environment. Evidence to support appropriate wound dressings under TCC is currently unavailable despite recognition that the wound environment and thus the amount of drainage changes as the wound progresses towards healing. This pilot case series of three patients with plantar based diabetic neuropathic ulcers uses two dressings, a five layer silicone foam with absorbent polymer and moisture retentive backing dressing (SF)* for low to moderate drainage and a non-adherent super-absorbent (SAP)† polymer dressing for moderate to high exudate levels.

 

Clinical Problem: May TCC kits include a generic, open-cell, polyurethane foam dressing (OCF). These dressings do not absorb or retain fluid in a moderate to high exudate environment which can lead to maceration and non-healing. Furthermore, due to the high moisture vapor transmission rate of OCF, wounds with low exudate may experience desiccation and result in the development of slough and biofilm … read more

Nearly 50% Reduction in Diabetic Foot Ulcers With Stem Cells

MUNICH — Local injection of mesenchymal stem cells derived from autologous bone marrow shows promise in healing recalcitrant neuropathic diabetic foot ulcers, a novel study from Egypt shows.

 

Presenting the results at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting, Ahmed Albehairy, MD, from Mansoura University, Egypt, said: “In patients who received the mesenchymal stem cells, ulcer reduction was found to be significantly higher compared with patients on conventional treatment after both 6 weeks and 12 weeks of follow-up. This is despite the fact that initial ulcer size was larger in the stem-cell–treated group.”

 

After 6 weeks, median ulcer reductions were 49.9% and 7.67% (P = .001) in stem-cell–treated and control groups, respectively, and after 12 weeks, median ulcer reductions were 68.24% and 5.27% (P = .0001). Complete healing was achieved in one case in the mesenchymal stem cell–treated group.

 

“The healing mechanism may be due to the pure effect of injected mesenchymal stem cells, which is due to the ability of these cells to simulate angiogenesis in the wound bed, decrease excessive inflammation, and suppress scarring,” explained Dr Albehairy … read more

Molecular study of wound healing after using biosynthesized

     BNC/Fe3O4 nanocomposites assisted with a bioinformatics

 

Magnetic nanoparticles were biosynthesized by using Aloe vera extract in new isolated bacterial nanocellulose (BNC) RM1. The nanocomposites were characterized using X-ray diffraction, Fourier transform infrared, and field emission scanning electron microscopy. Moreover, swelling property and metal ions release profile of the nanocomposites were investigated. The ability of nanocomposites to promote wound healing of human dermal fibroblast cells in vitro was examined. Bioinformatics databases were used to identify genes with important healing effect. Key genes which interfered with healing were studied by quantitative real time PCR.

 

Results: Spherical magnetic nanoparticles (15–30 nm) were formed and immobilized within the structure of BNC. The BNC/Fe3O4 was nontoxic (IC50>500 μg/mL) with excellent wound healing efficiency after 48 hours. The nanocomposites showed good antibacterial activity ranging from 6±0.2 to 13.40±0.10 mm against Staphylococcus aureus, Staphylococcus epidermidis and Pseudomonas aeruginosa. The effective genes for the wound healing process were TGF-B1, MMP2, MMP9, Wnt4, CTNNB1, hsa-miR-29b, and hsa-miR-29c with time dependent manner. BNC/Fe3O4 has an effect on microRNA by reducing its expression and therefore causing an increase in the gene expression of other genes, which consequently resulted in wound healing … read more

VTT is developing 3-D-printing materials for wound care

     and decorative elements

 

Cellulose nanofibrils have properties that can improve the characteristics of bio-based 3D-printing pastes. VTT Technical Research Centre of Finland is developing a 3D wound care product for monitoring wound condition in hospital care. However, the first commercial nanocellulose applications will be seen in indoor decoration elements, textiles and the production of mock-ups.

 

3D printing has proven to be an efficient manufacturing method for complex, customised and light structures. In addition to thermoplastics, 3D printing materials include metals, ceramics and foodstuffs. The range of biomaterials in 3D paste printing is still fairly limited, since pastes pose unique challenges: their structure must not collapse during printing and the objects manufactured must remain sufficiently strong, rigid or flexible after drying. In 3D biomaterial filaments, however, commercial products already exist … read more

Human Adipose-Derived Stem Cell Conditioned Media and Exosomes Containing

MALAT1 Promote Human Dermal Fibroblast Migration and Ischemic Wound Healing

 

Abstract

Objective: Chronically ill patients heal recalcitrant ulcerative wounds more slowly. Human adipose-derived stem cells (hADSCs) play an important role in tissue regeneration and exosomes secreted by hADSC contribute to their paracrine signaling. In addition to cytokines, lipids and growth factors, hADSC secrete mRNA, miRNA, and long noncoding (lnc) RNA into exosomes. In this study we examined the role of lncRNA MALAT1 (metastasis-associated lung adenocarcinoma transcript 1), an abundant lncRNA in exosomes from conditioned media (CM), on cell migration and ischemic wound healing.

Approach: CM and isolated exosomes from hADSC were applied to human dermal fibroblast (HDF) in scratch assays and electric cell-substrate impedance sensing (ECIS) assays. CM was also applied to a rat model of ischemic wound healing and wound closure was followed.

Results: CM stimulated cell migration of HDFs in vitro by 48%. CM stimulated the closure of ischemic wounds in a rat model 50% faster than unconditioned media. The depletion of MALAT1 in adipose-derived stem cell (ADSC) CM significantly reduced cell migration. Since MALAT1 is secreted into exosomes, a purified population of exosomes was applied to HDF where they enhanced cell migration in a similar manner to FGF-2 or basic fibroblast growth factor (bFGF) in ECIS wound healing assays. The uptake of exosomes by HDF was shown using dynasore, an inhibitor that blocks clathrin- and caveolin-dependent endocytosis. Depletion of MALAT1 in hADSC with antisense oligonucleotides resulted in exosomes without MALAT1. These exosomes had an effect similar to the unconditioned, control media in ECIS assays …. read more (fee)

Using technology to reduce waste and improve surgical care

Every day, millions of patients undergo procedures in ambulatory surgery centers (ASCs), and a very small percentage of them have complications during and after the procedure. Fortunately, new technologies promise to address problems that have challenged patients and their surgical teams.New analytical tools using artificial intelligence and machine learning, coupled with data streams from patients, can be used to better understand patient risk sand develop treatment strategies to reduce complications and improve outcomes.These new tools promise to reduce waste (defined as care that does not add to the patient’s health).For example, a patient who develops a wound infection post-operatively that requires re-operation and hospital admission may benefit from those interventions, but if the patient had gotten treatment earlier for the wound infection,hospitalization and re-operation could have been avoided altogether. Waste is common in our healthcare system today, but things are already starting to change.

 

How can new technologies reduce waste and improve outcomes for patients treated in ASCs? These tools can help predict risk of complications, better manage surgical procedures, and post-operative recovery.Physicians and teams managing surgical patients face several difficult issues: when is it safe to take my patient to surgery? What are the identifiable risks of surgery for this patient and what can be done to minimize those risks? How can the surgery be made as safe as possible? What does this patient need to heal successfully after surgery and what can be done to minimize surgical complications that require treatment? Better answers to these questions lead to better outcomes for patients and reduce wasteful expenditures … read more

Microcurrent as an adjunct therapy to accelerate chronic wound healing

     and reduce patient pain

 

The primary aim is to assess the efficacy of microcurrent, a form of electrical stimulation, as an adjunct therapy in accelerating healing in chronic wounds by reducing wound size and pain level. The secondary aim is to assess the qualitative changes in these parameters: inflammatory symptoms, vasodilation, sleep quality, gait and frequency of bowel movement … read more

Prevention of Plantar Ulcers in People With Diabetic Peripheral Neuropathy

Using Pressure-Sensing Shoe Insoles

 

The SurroSense Rx system is a set of pressure-sensing shoe insoles that connect wirelessly to a proprietary smartwatch and is intended for people with diabetes who have mild to moderate sensory loss associated with diabetic peripheral neuropathy, or nerve damage. By providing real-time alerts about plantar pressure distributions, or the area of pressure between the foot and the surface supporting it, users of the SurroSense Rx system can alter their activities in order to relieve unsafe pressures. The SurroSense Rx system is used in addition to current standard-of-care treatment for the prevention of plantar ulcers in diabetic patients. There is currently no available evidence that using the SurroSense Rx system prevents plantar ulcers. However, there are ongoing clinical trials that may identify patient populations that will benefit from its use.

 

Over time, high blood sugar in people living with diabetes causes damage to the peripheral nerves — the nerves that serve the arms, hands, legs, and feet. This damage, called diabetic peripheral neuropathy, includes symptoms such as painful tingling or burning sensations in the hands and feet, and the loss of protective sensations such as feeling pain or temperature changes. When pain sensation is lost, there is an increased risk of developing open sores caused by prolonged pressure or other injuries … read more

Surgical wound dehiscence: Improving prevention and outcomes

Surgical wound dehiscence (SWD) is almost certainly under-reported, not least because of variation in the interpretation of what constitutes SWD. As a result, patients with SWD may not receive optimal treatment and may experience additional surgical site complications, increased mortality, prolonged hospital stays and readmission. Following a meeting in July 2017, an international panel of clinical experts developed a consensus document to raise awareness of SWD, to aid identification of patients at increased risk and to provide practical guidance in prevention and management. This document has the endorsement of the World Union of Wound Healing Societies (WUWHS) and ultimately aims to improve outcomes for patients … read more

Chronic Wound Management

     Optimizing the Wound Healing Environment

 

Chronic wounds are any types of wounds that have failed to heal in 90 days. Identifying the cause of a chronic wound is most important in the healing process. We as clinicians must help bolster advanced wound care by sharing advances in education in evidence-based treatment, prevention, and wound assessment.

 

A wound must go through hemostasis, inflammation, proliferation, and remodeling, along with various cellular contributions. The scaffolding of the extracellular matrix is what provides the elasticity and tensile strength to the skin structure. Various proteins such as collagen, fibronectins, elastins, and laminins make up this vital matrix to aid and complete the process of wound closure. We see extracellular matrix damage mostly in our geriatric population … read more

Nutrition in patients with chronic non-healing ulcers

     a paradigm shift in wound care

 

Chronic ulcers continue to pose a significant clinical and economic burden for both patients and wound care practitioners. Despite good standard of care (SOC), many wounds fail to heal. Wound healing requires a complex cascade of physiologic and immunologic processes as well as proper nutrition. An adequate balance of macro- and micronutrients is important to support the cellular activities that are necessary for repairing and remodeling of tissue. Despite being well documented in a number of clinical studies there continues to be a gap in recognizing nutritional deficits as well as appropriate clinical interventions in patients with chronic wounds. Effective management of malnutrition in patients with chronic wounds requires collaboration among multiple clinical disciplines. A holistic nutritional management approach may yield both clinical and economic benefits … read more

TissueTech, Inc. Awarded Patent for Compositions of

Morselized Umbilical Cord and Amniotic Membrane

 

MIAMI–(BUSINESS WIRE)–TissueTech Inc., the pioneer in the development and clinical application of regenerative amniotic tissue-based products, announced that it has been awarded patent 9,808,491 by the U.S. Patent Trademark Office. The patent applies to the use of a gel composition comprising morselized placental amniotic membrane and/or morselized umbilical cord. as a method for treating an ocular wound or repairing damaged ocular tissue.

 

“TissueTech has been the leader in the development and clinical application of amniotic membrane transplantation for the treatment of a variety of patient conditions in ophthalmology, chronic wound care, orthopedics and sports medicine,” said Amy Tseng, Chief Executive Officer of TissueTech. “We are excited that this patent represents our continued innovation and is another step forward in excelling our technological advances in the industry.”

read more

The Whole Patient Approach

Addressing Common Comorbidities That Affect Wound Healing

 

When developing the plan of care for the patient with a chronic wound, it is imperative first to look at the “whole” patient and not just the “hole” in the patient.1 As we do, we are able to review any medical conditions or disease states that may affect wound repair and healing. Millions of Americans are affected by chronic wounds each year. These wounds include causes such as diabetic foot ulcers, venous leg ulcers, arterial insufficiency, and pressure ulcers. Common comorbid conditions that can affect healing include diabetes, venous insufficiency, peripheral arterial disease, cardiopulmonary and oxygen transport conditions, immune deficiencies, and dementia.2 This discussion is focused on these conditions and factors that contribute to chronic wounds and their management … read more

Connected sensors for the prevention of chronic ulcers

As advancements in connectivity and miniaturization of electronics are made, smart sensors are beginning to find traction within the wound care pathway. IDTechEx has published a report titled Advanced Wound Care Technologies 2018 – 2028 and have previously reported on why disruption is needed in wound care in the next 10 years. Here, we explore a few connected devices that can contribute to the prevention of chronic wounds of pressure ulcers (PUs) and diabetic foot ulcers (DFUs).

 

Sensors for the Prevention of Pressure Ulcers MedicusTek have created the Sensable Care system which relies on a connected sensor pad or sensor mattress for detection of patient positioning to prevent pressure ulcer formation. By tracking patient position over time, the Sensable Care system can determine which areas of the patient are being exposed to prolonged pressure and notify caregivers accordingly for repositioning. The system resets if the patient successfully repositions themselves, thus decreasing the burden on caregivers where possible. Moreover, caregivers can receive immediate feedback as to whether their repositioning efforts were adequate in reliving the excessive pressure.

Read more at: https://www.wearabletechnologyinsights.com/articles/14270/connected-sensors-for-the-prevention-of-chronic-ulcers

New engineering method could overcome barriers in diabetes cell therapy

Pancreatic cell transplants have the potential to be a permanent treatment for Type 1 diabetes. Problem is, the cells have trouble forming the blood vessel networks they need to thrive and provide insulin to patients. So scientists in the U.S. and Japan devised a new tissue engineering method to tackle this blood-supply problem in pancreatic cell transplantation. Using the method, they created pancreatic islets that cured severe Type 1 diabetes when they were transplanted into mice.

 

Human pancreatic islets tend to lose their blood vessels while being prepped for transplant, and attempts to combat this—including creating new islets from stem cells—have been largely unsuccessful, the researchers, from Cincinnati Children’s Hospital and Yokohama City University (YCU), wrote in their study. So to speed up vascularization in transplanted tissues, the researchers, led by Takanori Takebe of Cincinnati Children’s and Hideki Taniguchi of YCU, created a technique called self-condensation cell culture … read more

Australian diabetes-related foot disease strategy 2018-2022

The first step towards ending avoidable amputations within a generation

 

Diabetic Foot Australia September 2017

 

Introduction
On any given day in Australia, the national burden of diabetes-related foot disease (DFD) is
significant:
• 300,000 people are at-risk of developing DFD
• 50,000 people are living with DFD
• 12,500 people are living with a diabetes-related amputation
• 1,000 people are in hospital because of DFD
• 12 people will undergo a diabetes-related amputation
• 4 people will die because of DFD
• $4 million will be spent managing DFD
To reduce this large national burden, the following three priorities should be addressed for people
with, or at-risk of, DFD:
A. Access to affordable and effective care
B. Provision of safe quality care
C. Research and development to improve patient outcomes

download pdf

Double-Blinded Clinical Trials

A Gift from the Devil’s Grandmother

 

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

Editor’s note:This blog post is part of the WoundSource Trending Topics series, bringing you insight into the latest clinical issues and advancement in wound management, with contributions by the WoundSource Editorial Advisory Board.

 

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 … read more

IDTechEx Research Report Explores Connected Sensors

for the Prevention of Chronic Ulcers

 

As advancements in connectivity and miniaturization of electronics are made, smart sensors are beginning to find traction within the wound care pathway. IDTechEx Research has published a report titled Advanced Wound Care Technologies 2018–2028 and have previously reported on why disruption is needed in wound care in the next 10 years. Here, IDTechEx explores a few connected devices that can contribute to the prevention of chronic wounds of pressure ulcers (PUs) and diabetic foot ulcers (DFUs).

 

Sensors for the Prevention of Pressure Ulcers

MedicusTek have created the Sensable Care system which relies on a connected sensor pad or sensor mattress for detection of patient positioning to prevent pressure ulcer formation. By tracking patient position over time, the Sensable Care system can determine which areas of the patient are being exposed to prolonged pressure and notify caregivers accordingly for repositioning. The system resets if the patient successfully repositions themselves, thus decreasing the burden on caregivers where possible. Moreover, caregivers can receive immediate feedback as to whether their repositioning efforts were adequate in reliving the excessive pressure … read more

The Risky Business of Wound Research, Algorithms and Systems

by Margaret Heale RN, MSc, CWOCN

 

The research lecturer’s name was Terry, and he had my respect and attention. Many of the students were dreading the research modules but were cheered by the prospect of Terry taking us through it.

 

Terry included this little gem in his introduction to research. A group of researchers came up with a hypothesis that spiders had ears in their legs. How could they prove this, they wondered. They procured some arachnids of exactly the same type and took great pains to match them for all important parameters. They checked carefully the hearing of each. Placing them in turn in a quiet, stable tray, each time they yelled “Run!” every spider would take off at speed at the sound. The next step was to remove the spiders’ ears, so the legs of each spider were removed. Now when the researchers yelled “Run!” the spiders did not hear and did not move at all. So there you have it, clear undeniable proof, spiders have ears in their legs. It is very easy to see the flaw in this rather cruel piece of research, but sadly it is not always that easy … read more

Total Contact Cast Offloading Real Treatment For All Plantar Based Wounds

 

Patient is a 49 year old male with a history of Charcot Marie Tooth Disease (CMT) who presented with a a plantar ulcer of the Left Foot. CMT is an inherited neuropathy which directly damage nerves fibers resulting in both sensory and motor neuropathy causing significant foot deformities. His medical history included an unknown type of reconstructive surgery to the left foot in 2007 for his CMT. The presenting plantar ulcer had been there for 7 months and treated continuously by a local podiatrist with Iodine dressings only. The patient had never been prescribed any offloading devices and presented wearing canvas sneakers. Our Initial treatment consisted of aggressive debridement of the ulcer to 100% bleeding surfaces including all skin margins. Hemostasis was achieved rapidly using Scion CLO-SURPLUS PADTM Chitosan Hemostatic dressing. M-Med’s Mobility Series Total Contact Cast Kit was used to allow for modification for his unusual foot configuration. He underwent total contact casting weekly with complete healing in 5 weeks. The multi-component TTC system allowed for modifications by adding, subtracting or modifying components for the desired fit needed at that time. He was placed in a custom molded shoe with inserts and has had no recurrence to date … read more

The Healing Trajectory: The Process of Wound Healing

There are four stages of wound healing. This systematic process moves in a linear direction. The four stages of wound healing are: hemostasis, inflammation, proliferation, and maturation. It is imperative to remember that wound healing is not linear. It is possible for a patient to move forward or backward through the wound healing phases due to intrinsic and extrinsic forces … read more

 

 

Clinical Evidence Presented at SAWC on Application of AMNIOX Medical Products

Four Posters Demonstrate the Clinical Benefits of NEOX® Wound Allograft Presented at SAWC

 

MIAMI–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, highlighted four clinical posters demonstrating the effectiveness of NEOX® Wound Allograft at the Symposium on Advanced Wound Care (SAWC) in April.

 

The presentations illustrate applications of NEOX Wound Allograft in combination with other therapies, and among a range of severe wounds that are resistant to current standard of care or are under served.

 

“The clinical effectiveness and value of NEOX continues to be reinforced in these studies, as well as opportunities to combine different approaches to advanced wound care,” said Adrian Roji, Chief Commercial Officer of TissueTech. “The authors found that patients who received NEOX experienced closure of hard-to-heal wounds, further highlighting the unique properties of cryo-preserved umbilical cord tissue.”

 

The studies presented at SAWC included:

  • Treatment of Post-Operative Left Temporal Wound with Umbilical Cord Based Particulate and Negative Pressure Wound Therapy, Timothy Plackett, DO
  • Use of Hydrated Shelf Stable Umbilical Cord Allograft for the Treatment of Chronic Wounds, Allen Raphael, DPM
  • Treatment of Close-Range Gun Shot Wound with Umbilical Cord Based Particulate (pUC) and Negative Pressure Wound Therapy Timothy Plackett, DO
  • Treatment of Invasive Carcinoma Wound with Hyperbaric Oxygen and Cryopreserved Umbilical Cord, Luis Fernandez, MD

 

AMNIOX parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote healing. AMNIOX utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 300,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

 

About AMNIOX Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, AMNIOX Medical is dedicated to developing and marketing products processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. AMNIOX Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.AMNIOXmedical.com.

 

About TissueTech, Inc.

TissueTech, Inc., the parent company of AMNIOX Medical, Inc. and BioTissue, Inc., pioneered the development and clinical application of amniotic tissue-based products. AMNIOX Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing.

Original release from BusinessWire

Current challenges and opportunities in wound care

3 CNOs weigh in

 

Wound care costs the U.S. healthcare system an estimated $50 billion annually. The large fiscal burden suggests wound care may be an overlooked target for quality improvement and cost reduction initiatives, according to Jacksonville, Fla.-based Healogics, the nation’s largest provider of advanced wound care services.

 

More than 30 million diabetics and 28.4 million individuals with heart disease reside in the U.S. Both morbidities represent public health epidemics and carry a heightened risk for chronic wound development. Approximately 6.7 million Americans are afflicted with chronic, non-healing wounds. This figure does not account for wounds attributable to conditions such as necrotizing fasciitis and surgical wounds related to the operating room. The Healogics team asserts that these numbers suggest America is experiencing a chronic wound epidemic.

 

On April 11, at Becker’s Hospital Review 9th Annual Meeting in Chicago, Arti Masturzo, MD, executive vice president of clinical innovation with Healogics, led a group of hospital leaders in a discussion on current challenges and opportunities related to wound care … read more

The Benefits of Effective Wound Debridement

by The WoundSource Editors

Overview of Debridement in Wound Care

Debridement is essential to promote healing and prevent infection. There are five main types of debridement methods. BEAMS is the common mnemonic to remember all types: biological, enzymatic, autolytic, mechanical, and surgical. In recent years, new types of debridement technology have been introduced, such as fluid jet technology, ultrasound debridement therapy, hydrosurgery, and monofilament polyester fiber pad debridement.

 

Combining debridement methods has been found to be an advantage in managing complex wounds and different pathological tissues since 2006. One common method of combining debridement techniques is using enzymatic debridement first to liquefy the tissue and then following with sharp debridement. Combining debridement methods in this way can ensure that you are removing as much dead tissue from the wound as possible and helping to promote wound healing.

 

Chen and Wang studied chronic pressure ulcers that were described as dry, hard, black, crusting eschar … read more

Ally Medical, Preston Wound Care merge under Acentus

TAMPA, Fla. – Principles from Tampa, Fla.-based Ally Medical Services and McKinney, Texas-based Preston Mobility Plus, dba Preston Wound Care, have merged. They’re now wholly owned subsidiaries of Acentus, also based in Tampa. Ally Medical is one of Florida’s larges providers of incontinence and medical nutritional supplies to children with special healthcare needs, and urological catheters to the neurogenic bladder patient population. Preston Wound Care is one of Texas’ largest wound care providers to patients living at home with diabetic ulcers and chronic wounds … read more

Staphylococcus aureus Toxins and Diabetic Foot Ulcers

Role in Pathogenesis and Interest in Diagnosis

 

Infection of foot ulcers is a common, often severe and costly complication in diabetes. Diabetic foot infections (DFI) are mainly polymicrobial, and Staphylococcus aureus is the most frequent pathogen isolated. The numerous virulence factors and toxins produced by S. aureus during an infection are well characterized. However, some particular features could be observed in DFI. The aim of this review is to describe the role of S. aureus in DFI and the implication of its toxins in the establishment of the infection. Studies on this issue have helped to distinguish two S. aureus populations in DFI: toxinogenic S. aureus strains (harboring exfoliatin-, EDIN-, PVL- or TSST-encoding genes) and non-toxinogenic strains. Toxinogenic strains are often present in infections with a more severe grade and systemic impact, whereas non-toxinogenic strains seem to remain localized in deep structures and bone involving diabetic foot osteomyelitis. Testing the virulence profile of bacteria seems to be a promising way to predict the behavior of S. aureus in the chronic wounds … read more

Hydrogel Dressings an emerging area for wound care

 

By Liji Thomas, MD

 

An emerging area for wound care is hydrogel dressings as they increase success and speed of wound healing due to the ability to maintain optimum wound healing environment superseding conventional dressings.

 

Hydrogel dressings consist of 90% water suspended in a gel made of insoluble hydrophilic polymers that swell up on contact with water, which are typically synthetic molecule polymers such as polyvinylpyrrolidine and polymethacrylate combined with alginate dressings, that control fluid exchange on wound-bandage interface with sodium and/or other molecules in wound discharge being exchanged for hydrogel compounds.

 

Hydrogel provides moisture to enable painless debridement of infected and necrotic tissues, promoting granulation while encouraging complete healing. Hydrogel dressings have high water content which makes them not completely absorbent and appropriate only for wounds with light to moderate exudation. Skin maceration and/or multiplication of microbes can result from water accumulation which can lead to foul smelling infected wounds. The cooling hydrogels can alleviate some pain, which flatten out the wound surface contours and prevent dead space from getting infected, while providing support for surface healing.

 

Hydrogel sheets are polymeric cross linked molecules capable of absorbing some water helping to prevent wounds with light exudation from becoming to wet with semipermeable polymer film backings. Evaporation is regulated with the backing and keeps wounds from drying out. Sheets can be cut to shape and size, and may be used as secondary or primary dressings … read more

 

National Alliance of Wound Care and Ostomy®

     Board of Directors Elect New President

 

Moore will lead the Board of Directors of the largest wound care credentialing organization in the United States

 

For Immediate Release:
May 7, 2018, St. Joseph, MI—National Alliance of Wound Care and Ostomy (NAWCO®) Board of Directors announced today, it has elected Ms. Ottamissiah (Missy) Moore, RN, WCC, DWC, GC, CSD-LTC, President of the Board.

 

“As a long-standing member of our Board of Directors, Missy’s forwardthinking contributions have helped articulate our vision. We welcome her leadership as President to elevate our mission further,” said Cindy Broadus, Executive Director NAWCO.

 

Moore is a past president of the National Federation of Licensed Practical Nurses and a Lifetime member of the National Black Nurses Association. She served on the board for the District of Columbia State Board of Nursing and other appointed committee positions including:

 

  • National Council of State Boards of Nursing, PN NCLEX Item Selection Committee
  • Commission of Graduates of Foreign Nursing Schools, LPN Standards Committee
  • National League for Nursing Licensed Practical Nurse Ad Hoc Committee.

 

“I am thrilled and honored to be elected President of the NAWCO Board of Directors. I am committed to elevate our support for this amazing group of certified healthcare clinicians,” said Moore.

 

Missy is employed as Community Liaison at Right at Home Of DC, located in Washington D.C. and Wound Education Consultant for Quality In-services and Training.

 

About NAWCO NAWCO is a non-profit credentialing board, dedicated to the advancement and promotion of excellence in wound care and ostomy management. NAWCO is the largest and fastest growing credentialing organization in the field of wound care and ostomy management for Nurses, Nurse Practitioners, Physical Therapists, Physical Therapy Assistants, Occupational Therapists, Occupational Therapy Assistants, Registered Dietitians/Registered Dietitian Nutritionists, Physician Assistants, and Physicians. For more information about NAWCO certifications, visit www.nawccb.org.

Finesse Medical expands to create 200 jobs in Longford

Longford-based manufacturing company Finesse Medical, which was acquired by New York-listed Avery Dennison in a multimillion-euro deal last May, is to create 200 jobs locally over the next four years.

 

The news was announced as its parent said it planned to expand its medical product manufacturing operations at the Longford facility.

 

Avery Dennison said on Thursday that construction on a 6,000sq m facility expansion that will include a new clean room, integrated converting and manufacturing capabilities, will begin in September.

 

Set up in 2004, Finesse makes products for wound care and skin treatment, including skin barrier films and protection creams, and silicone and polyurethane foam wound dressings. It manufactures on behalf of a number of customers and posted revenues of about €15 million over the past year … read more

 

 

Hemoglobin A1c Levels Not Tied to Wound Outcomes

HealthDay News — There does not appear to be a clinically meaningful association between baseline or prospective hemoglobin A1c (A1C) and wound healing in patients with diabetic foot ulcers (DFUs), according to a study published online April 16 in Diabetes Care.

 

Betiel K. Fesseha, MD, from Johns Hopkins University in Baltimore, and colleagues retrospectively evaluated the association between A1C and wound outcomes in 270 patients with 584 DFUs over a study period of 4.7 years… read more

 

 

Factors associated with amputation among patients

with diabetic foot ulcers in a Saudi population

 

Abstract

Objectives

A prospective study was conducted at the Armed Forces Hospital, Dhahran, Saudi Arabia, between January 2015 and December 2016 to identify the risk factors associated with amputation among diabetic foot ulcers DFUs patients.

Results

In total, 82 patients were recruited. Fifty-five of the patients were males (67.07%), the mean (SD) age of the participants was 60 (± 11.4) years, the mean duration of diabetes was 8.5 (± 3.7) years, and the mean haemoglobin A1c was 4.8 (± 2.8)%. In Univariate analysis, older age and high white blood cell count (WBC) were factors associated with amputation (OR = 1.1, 95% CI = 1–1.1, P = 0.012; and OR = 383, 95% CI = 7.9–18,665, P = 0.003, respectively). On the other hand, an ischaemic ulcer was half as likely as a neuropathic ulcer to lead to amputation (OR = 0.5, 95% CI = 0.3–0.9, P = 0.036), and a higher Wagner’s grade was found to be protective against amputation OR = 14.5, 95% CI = 4.3–49.4, P < 0.001. In conclusion, the current study showed that although a number of factors have been described to complicate diabetic ulcers by different researchers, none of those factors were identified in our study apart from older age and high WBC.

Introduction

Diabetes mellitus is a common endocrinopathy known for its various complications, including diabetic foot ulcers (DFUs) which often result in amputated limbs [1]. The prevalence of foot ulcers among patients with diabetes mellitus ranges from 4 to 10%, and its lifetime incidence may reach up to 25% [2]. Conservative management of DFU may be affected by proper offloading of the wounds, correct daily foot hygiene, and impaired distal vascular flow. Treatment of a DFU is difficult; it frequently gets infected, and it is therefore a very common cause of hospitalization [3]. Diabetes mellitus increases the risk of lower extremity amputations (LEAs) by up to 56% over 5 years, and … read more

HMP’s EMS World Expo Recognized as one of the Top 25

Fastest-Growing Trade Shows in Attendance by Trade Show News Network

 

MALVERN, PA. (PRWEB) APRIL 26, 2018

HMP, a leading healthcare education and events company, today announced that its EMS World Expo has been recognized as one of the “Top 25 Fastest-Growing Shows in Attendance” by Trade Show News Network (TSNN). The list represents trade shows held between 2015-2017 and is ranked by overall attendance growth over that period. Winners will be honored during the 2018 TSNN Awards, taking place August 10-12 in Louisville, Kentucky.

 

Owned and produced by HMP, EMS World Expo is the largest EMS-dedicated event in the world and annually attracts thousands of emergency medical technicians and paramedics. With more than 250 educational sessions, EMS World Expo sets the standard in EMS education, offering the latest information, tools, technologies, and trends in prehospital care.

 

“Being recognized by Trade Show News Network as one of the fastest-growing trade shows in the U.S. is a great honor,” said Joshua D. Hartman, MBA, NRP, vice president, public safety division, HMP. “The growth reflects our commitment to providing quality education in prehospital care to EMS professionals in the U.S., and around the world.”

 

In 2017, more than 5,700 attendees from 50 countries participated in EMS World Expo. In addition to a trade show floor spanning 70,900 sq. ft., the 2017 exposition featured more than 360 exhibitors showcasing innovative products, services, and technologies to improve patient care, enhance provider safety, and increase operational efficiencies.

 

The 2018 EMS World Expo will take place October 29-November 2, in Nashville, Tennessee. For more information, visit emsworldexpo.com.

 

About EMS World Expo
As the largest EMS-dedicated event in the world, EMS World Expo, hosted in partnership with the National Association of Emergency Medical Technicians (NAEMT), annually attracts more than 5,700 EMS professionals. EMS World Expo sets the standard in EMS education, offering the training professionals need to do their jobs today, with the progressive curriculum and technology that provides the solutions for tomorrow.

 

About HMP
HMP is the force behind Healthcare Made Practical—and is a multichannel leader in healthcare events and education, with a mission to improve patient care. The company produces accredited medical education events and clinically relevant, evidence-based content for the global healthcare community across a range of therapeutic areas. Its brands include Consultant, the monthly, award-winning journal relied upon by primary care providers; Psych Congress, the largest independent mental health meeting in the U.S.; and the Symposium on Advanced Wound Care (SAWC), the largest wound care meeting in the world. For more information, visit hmpglobal.com.

Original post in PRWeb

Wound Documentation Standards to Help Avoid Legal Issues

Medical providers, and especially wound care providers, seem to always be under the looming shadow of lawsuits and legal issues. I have written about this before, but it continues to be an issue as I receive requests for legal reviews repeatedly. I have read many charts for legal reviews, and it actually is very straightforward to avoid or mitigate any legal problems.

 

Important Steps to Take When Documenting a Wound

1. If you have a wound protocol, follow it or document why you didn’t. For example, if your protocol says a bed or chair bound patient on admission is high risk, then treat them as high risk, or document why you didn’t.

2. If you use an assessment tool such as Braden Scale or Norton Scale, be sure you know how to use it properly, and use it per protocol.

3. Document all calls to a physician and the response.

4. If there is a physician order, follow it and document that you adhered to the order.

  • For example, if an order says to notify physician if there is blood in the urine and you see blood in the Foley catheter, notify the physician and document that you did notify them and what the response was.

5. If you notice a change in your patient, report it to the proper person. For example: the patient has stopped eating normally, or the patient is acting differently. In an elderly patient this could be the first sign of infection … read more

AmpliPhi Biosciences Will Utilize NIAID Preclinical Services to Advance

Development of Its Targeted Therapeutic Candidate for the Treatment of Resistant Staphylococcus Aureus

 

SAN DIEGO–(BUSINESS WIRE)–AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced that it will utilize the Therapeutic Development Services funded by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), to conduct further preclinical studies of AB-SA01. The Therapeutic Development Services program funds the provision of preclinical services for selected companies and researchers in order to advance development of promising interventional agents.

 

“We are pleased and encouraged by the support from the NIAID and its commitment to studying the role of bacteriophage in combating infectious diseases,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “This service will help support the development of bacteriophages as a much needed treatment for antibiotic-resistant infections.”

 

AB-SA01 is a 3-phage investigational therapeutic being developed for treatment of serious and drug-resistant Staphylococcus aureus (S. aureus) infections. In preclinical studies, AB-SA01 demonstrated broad activity against more than 96% of global S. aureus clinical isolates, including multidrug-resistant forms. AB-SA01 has completed two Phase 1 studies and has also been administered to patients under compassionate use guidelines in the U.S. and Australia for treatment of serious and life-threatening S. aureus infections … read more

Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers

This paper studies the healing effect of recombinant human epidermal growth factor (EGF) on chronic diabetic foot ulcers. A total of 89 patients (65 male and 24 female) aged from 36 to 82 years (average of 54) enrolled for the prospective, open-label trial, crossover study. Predetermined criteria were used for diagnosis and classification of ulcer. The average duration of ulcer was 6 months (range from 3 to 27 months) prior to study. Upon study, the ulcers were debrided and treated with hydrocolloid or composite dressing depending on the condition of the wound. If treatment effect was minimal using advanced dressing for 3 weeks, patients were crossed over to twice-a-day treatment with 0.005% EGF and advanced dressing. Among the patients, 21 patients showed improvement using hydrocolloid or composite dressing alone and 68 patients were crossed over to treatment with EGF and advanced dressing. In the EGF-treated patients, complete healing was noted in 52 patients within an average of 46 days (range from 2 to 14 weeks). Recurrence was not noted during the 6-month observation. But 5 patients showed new lesions different from the prior site. Sixteen patients required further interventions. This paper suggests that topical treatment with EGF combined with advanced dressing may have positive effects in promoting healing of chronic diabetic foot wounds.

original article from PubMed

Heberprot-P: a novel product for treating advanced diabetic foot ulcer

Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product’s potential to address an important unmet medical need.

Article from PubMed

Approval for commercialization of Heberprot-P® in Mexico

Havana, Cuba, May 4, 2018 – Heberprot-P® has been approved for commercialization in México. The Center for Genetic Engineering and Biotechnology (CIGB) is excited to announce regulatory approval of this innovative medicine indicated for advanced diabetic foot ulcer (DFU), which is expected to save thousands of people from lower limb amputation. The official approval date of Heberprot-P® was April 30th, 2018. Heberprot-P® stimulates granulation, accelerates DFU re-epithelization, and reduces healing time, surgical debridement, amputation risk, and recurrences. The intralesional infiltration of Heberprot-P® may be applied in combination with Good Wound Care (GWC), revascularization, and antibiotics. This medicine is an effective solution for an unmet medical need, a first in class product, unique worldwide, for DFU treatment. It is the only therapeutic choice available for advanced and complex DFU, reluctant to healing (grades 3, 4, and 5, according to Wagner’s classification).

 

Clinical experience derived from the intervention with Heberprot-P® in daily medical practice in Cuba was analyzed in 2013 in a study that reviewed the evolution of more than 2 000 patients as well as the pharmacovigilance of 1 788 patients, showing a 75% probability of granulation response, 61% healing rate, 71% amputation risk reduction, Bayes’ favorable factor (5.40), and complete granulation in 76% of ulcers in 5 weeks (Adv. Pharmacoepidem. 2013, 2 (2): 1000128; BMC Pharm. & Toxicol, 2013, 14: 44). The International Working Group of Diabetic Foot (IWGDF) evaluated results of the clinical trial performed with Heberprot-P® in Cuba and reported in 2009 as promising, highlighting the results obtained in only 2 weeks of treatment (Diabetes Metab Res Rev 2012; 28 (Suppl 1): 119-141).

 

In a later systematic review, clinical trials comparing the use of growth factors with GWC (Cochrane Database of Systematic Reviews 2015, Issue 10, Art. No. CD008548), the IWGDF’s evaluation was reported on all major issues and requirements of Heberprot-P® clinical trials in Cuba. Similar criteria were expressed by the IWGDF in the guidelines on DFU healing (IWGDF Guidance, 2015: 10). A fourth study reported similar observations on the intralesional EGF infiltration method: “… a highly significant difference between groups in the prevalence of granulation tissue after just 2 weeks” (Diabetes Metab Res Rev 2016; 32 (Suppl 1): 154- 168).

 

Results of clinical studies performed in Cuba, Russia, Turkey, Vietnam, Argentina, Mexico, and Ukraine were enough to demonstrate safety and efficacy profile of Heberprot-P®. This medicine has been used in more than 290 000 patients with diabetic foot ulcer (DFU) in Russia, Belarus, Georgia, Ukraine, Turkey, Algeria, China, Panama, Argentina, Cuba, Dominican Republic, Venezuela, Ecuador, Libya, Uruguay, Paraguay, Colombia, Guatemala, Philippines, Vietnam, Nicaragua, Saudi Arabia, Indonesia, Seychelles, Saint Lucia, Saint Vicente, Sri Lanka, Jordan, and Kuwait.

 

A national survey of health and nutrition in Mexico reported that prevalence of diabetes is 9.4% of total population, which sums up more than 11 million people, 9.1% of adult diabetic suffers DFU, and amputation is indicated to 5.5% of adult diabetics (National Survey of Health and Nutrition, INEGI 2016). According to recent reports, lower limb amputation is the unique alternative for 45% of diabetics with advanced DFU in Mexico (Diabet. Foot. Ankle. 2017 Sep 6, 8 (1): 1367210). In a previous study, similar results were reported: 42% patients with advanced DFU required major amputation (Wound Repair & Regen. 24 (5): 923-927).
Written by Jose A. Buxado, MSc., Assistant Researcher, CIGB.

 

The Center for Genetic Engineering and Biotechnology of Havana is an institution devoted to research, development, manufacturing, and commercialization of products and technology derived from life science.

 

Alyane Vazquez González, BA., Communication & Media, e-mail: alyane.vazquez@cigb.edu.cu
. Ave 31 e/ 158 y 190, Playa, P.O. Box 6162, Habana 10600, Cuba.

 

This release was published on openPR.

Diabetes UK commits £2.6 million to new research

  • New funding will be split between 14 new research projects and five new PhD grants
  • New research includes projects investigating whether medieval remedies can be used to treat foot ulcers, and if sleep disturbances can predict Type 2 diabetes

Diabetes UK has committed to invest £2.6 million in 19 brand new projects which aim to make life-changing improvements in diabetes care, and reduce people’s risk of Type 2 diabetes.

 

The funding will be given to projects looking into Type 1, Type 2 and gestational diabetes. In one of these projects, Dr Freya Harrison, from the University of Warwick, will be using medieval remedies to find new sources of antibiotics. She has already discovered a combination that can kill antibiotic-resistant bacteria in the lab. Dr Harrison will study this remedy further to investigate how it works and if it could be used to treat infected foot ulcers in the future.

 

There are more than 20 leg, foot and toe amputations each day due to diabetes, four out of five of which could be prevented. This research hopes to reduce the number of diabetes-related amputations and cases of sepsis, by treating foot ulcer infections more effectively.

 

Dr Martin Rutter, from the University of Manchester, has also been awarded Diabetes UK funding to find out if sleep problems can help predict who might be at risk of Type 2 diabetes. He will also look at whether sleep patterns in people with Type 2 diabetes can affect their blood glucose control, and their risk of serious diabetes-related complications, such as amputation, heart disease and blindness … read more

TUV Nord Awards ISO 13485 Certification to Keneric Healthcare

for the Design/Development, Manufacturing and Distribution of Wound Care Products

 

ALLEN, Texas, April 26, 2018 /PRNewswire/ — Keneric Healthcare’s ISO certification award represents its ability to design, implement, and successfully manage an effective quality management system that meets the requirements of DIN EN ISO 13485: 2012 / EN ISO 13485: 2012 +AC: 2012 – Medical devices – Quality management systems – Requirements for regulatory purposes. The scope of the ISO certification supports the Design/Development, Manufacturing and Distribution of Wound Care Products.

 

Keneric Healthcare, a global medical device manufacturer, recognized for the development and commercialization of innovative products that improve patient care, increase clinician efficiency and streamline facility expenditures. Product portfolio includes RTD™ Wound Dressing, an FDA cleared, polyurethane silver foam dressing that consistently demonstrates positive clinical outcomes for a variety of wound types; and PurePurge™ Bed bath System, an easy to use rinse-free patient bathing product offering healthcare professionals an ideal and cost-effective solution for bathing patients who are unable to take a traditional bath or shower.

Press release from PR Newswire

High School Senior Awarded Scholarship for Creating an Orthotic

that detects and prevents diabetic foot ulcers.

 

Western Albemarle high school senior Meg Richey is awarded a scholarship at the 18th annual Emily Couric Leadership Forum at the Omni Charlottesville Hotel on Wednesday. Richey, who will attend Stanford University, was awarded a scholarship of $30,000 for her work creating an orthotic that detects and prevents diabetic foot ulcers.

Meg Richey was this year’s main award winner, and she received a $30,000 scholarship.

 

A senior at Western Albemarle High School who plans to study computer science at Stanford University, Richey has a provisional patent for a medical device and is the youngest person to study at the University of Virginia’s Biomedical Engineering Design Lab.

 

Her device, named after her childhood bus driver, Mike Morris, was envisioned after Morris died after developing a diabetic foot ulcer.

 

“He was the first and last person we saw during the day,” Richey said. “It was so important, especially in middle school, to feel like someone genuinely cared.”

 

The Morris Orthotic is a custom foot insole with sensors that detect changes in pressure at the bottom of a diabetic patient’s foot. Possibly the first custom-fit orthotic with sensor technology, it might alert a patient to life-threatening conditions that are hard to detect … read more

Edixomed: Breakthrough Wound Care Technology

With Potential to Strike Back Against the Threat of Killer Superbugs

 

A simple patch which cleverly harnesses part of the body’s own natural repair system – nitric oxide – could help in the fight against killer superbugs and antibiotic resistance according to recently published studies.

 

Millions of people are at risk of dying from infections every day, many of which can no longer be treated by even the strongest antibiotics.

 

Now, in two recently published studies, a breakthrough wound care system, created by the UK firm Edixomed, has been shown to kill a range of antibiotic-resistant bacteria including MRSA and E. Coli, both of which have the potential to be fatal for many people.

 

The discovery could pave the way for these easy-to-use patches to be available in hospitals across the NHS to dress wounds to prevent the growth of bacteria, and tackle established infections.

 

“Bacterial infections resistant to all currently available antibiotics are expected to kill over 10 million people a year by 2050. The threat is very real and of international concern; but with this technology, we have a novel, viable and innovative solution with which to strike back. Wound care is just the first of many potential applications,” said Professor Art Tucker, St Bartholomew’s Hospital, London. He added, “Importantly, nitric oxide acts against multiple targets in bacteria to kill them, hence there is a very unlikely chance of bacteria developing resistance any time in the future.”

 

In addition, Edixomed’s breakthrough, the EDX110 wound care system, is able to deliver nitric oxide in a sustained way to give the wound or ulcer the best chance of healing. As part of the natural healing process the body normally produces nitric oxide and uses it to signal for increased blood flow and to fight infection. Edixomed’s technology effectively “supercharges” the body’s own natural healing processes.

 

In fact, recently published clinical research in diabetic foot ulcers, including infected ulcers, showed that the EDX110 patch achieved the same healing in 4 weeks as the standard-of-care approaches currently used in UK hospitals achieved at 12 weeks. The standard-of-care patients were also significantly more likely to be hospitalised due to complications with their foot ulcer.

 

“Diabetic foot ulcers are notoriously hard-to-heal and are the leading cause of diabetes-related amputations in the UK. The recently published findings provide an essential step forward in developing solutions for the effective management of these chronic wounds,” said Professor Michael Edmonds, Principal Investigator of the pivotal diabetic foot ulcer study, King’s College Hospital, London. He added, “Reducing infection and accelerating healing could significantly contribute to a reduction in the number of avoidable amputations. EDX110 represents a major step forward in best practice care.”

 

In severe cases, infection of a foot ulcer in a patient with diabetes can result in lower limb amputation or worse e.g. complications such as sepsis, multi-organ failure and death.

 

Facts:

  • The NHS carries out more than 7,300 amputations each year in the UK as a result of diabetes, 80% of these are due to foot ulcers.[4] The resulting drain on healthcare resources is enormous, with an annual cost of £1 billion to NHS England alone.[5]
  • At least 700,000 people die globally from drug-resistant infections every year – 5,000 of them in the UK.[6],[7]
  • There have been no new classes of antibiotics approved since the 1980s and the Chief Medical Officer, Professor Dame Sally Davies warned in 2017 that resistance to antibiotics “poses a catastrophic threat”.[8]

 

Key findings of the two recent studies investigating EDX110, a revolutionary new wound care system:

  • Laboratory tests have shown that EDX110 can kill all viable organisms for several deadly antibiotic-resistant infections including MRSA, Pseudomonas and E. Coli.[3]
  • Laboratory tests have shown that EDX110 effectively prevented and treated multi-drug resistant bacteria biofilms. Biofilms are colonies of bacteria that protect themselves from the body’s immune system and actions of antibiotics.[3]
  • EDX110 completely healed more ulcers compared with standard-of-care (ulcers completely healed: 49% vs. 30%).[2]
  • EDX110 reduced diabetic foot ulcer size by almost double the amount of standard-of-care (median percentage area reduction: 89% vs. 47%).[2]

 

About Edixomed

Edixomed is a biopharmaceutical company commercialising next generation and clinically-proven technologies from its nitric oxide platform. Using its patented scientific approach, the company’s technologies have the potential to tackle major global health challenges in wound care, dermatology and infection control. The core technology’s unique feature is its ability to replenish or supplement the body’s own supply of nitric oxide that is critical for sustaining healthy skin and organs. Nitric oxide is depleted or absent in many diseases and thus, the body’s normal healing and regenerative processes are damaged. Restoring that essential element is at the heart of Edixomed’s approach to innovative healthcare.

 

About EDX110

EDX110 is a revolutionary, easy-to-use, two-part wound care system, driven by Edixomed’s core sustained-release nitric oxide delivery technology. EDX110 provides a protective and cushioning layer that uniquely absorbs fluid while providing a moist environment and generating nitric oxide. The role of nitric oxide in ulcer healing involves three recognised elements: vascular, as nitric oxide influences the widening of blood vessels (vasodilation) and stimulates the growth of new blood vessels (angiogenesis);[9],[10] inflammatory, as nitric oxide influences the body’s immune response;[11] and antimicrobial, as nitric oxide demonstrates potent, broad spectrum antimicrobial activity.

 

EDX110 is not yet an approved product, Edixomed are pursuing an active programme to develop applications of their core technology in multiple wound care indications and a number of additional areas. These areas include: surgical wound care, venous leg ulcers, pressure ulcers, burns, septic shock, transdermal drug delivery, ventilator-associated pneumonia, cystic fibrosis, and various applications connected to antimicrobial resistance.

 

About nitric oxide

The discovery that a simple gas, nitric oxide, could play such an important role in the human body led to three scientists being awarded the Nobel Prize for medicine in 1998. The pioneering work demonstrated that the normal function of nitric oxide is to control blood flow in the small vessels in the skin and prevent the skin from being infected with dangerous organisms. Nitric oxide is also generated whenever the skin is injured or damaged and plays a crucial part in the normal skin healing process. However, in certain conditions, such as diabetes, the normal production of nitric oxide can be put at risk and the skin loses the essential ingredient it needs to repair itself. The result is a chronic, poorly healing wound, highly prone to infection and a major cause of concern to patients and doctors. Replenishing the missing nitric oxide in such a way as to mimic the skin’s natural production is no easy task and it has eluded many of the world’s leading scientists for the past two decades. Edixomed has succeeded in achieving this goal and has demonstrated the performance of its technology in a pivotal clinical trial.

You can also visit our website at: http://www.edixomed.com

 

Press Release from PR Newswire

Aroa Biosurgery and Hydrofera Team up in US

 

MANCHESTER, Conn. & AUCKLAND, New Zealand–(BUSINESS WIRE)–New Zealand biomedical company Aroa Biosurgery and United States medical products company Hydrofera are launching Appulse in North America.

 

The two companies have recently bought back their wound care businesses from Hollister Inc.

 

Brian Ward, CEO of Aroa Biosurgery, says the company’s Endoform wound care technology and Hydrofera Blue are complementary.

 

“We have both been successfully represented by Hollister, but with Hollister’s decision to divest portions of its wound care business back to the technology developers, it gives us the opportunity to now grow the businesses ourselves.”

 

Tom Drury, CEO of Hydrofera, says: “On June 1 we will launch Appulse and most of the Hollister sales team for Endoform and Hydrofera Blue will continue to represent both products.

 

“This will help ensure the same level of service to patients, clinicians and distribution partners.”

 

Endoform is a proprietary extracellular matrix (ECM) biomaterial, which contains a collagen scaffold and important secondary molecules to support healing.

original release