Innovations That Work!

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Every July, manufacturers and providers of innovative products and services are invited to share what’s new in the wound, ostomy, continence care arena. The Editors are delighted to share these Innovations That Work with our readers. The listings are alphabetical by product. Several listings include testimonials from clinicians with first-hand experience and knowledge of the products to enlighten your care decisions.

We hope you find this information useful; we encourage you to add your comments online and on our social media pages.

Product:  BlastX Antimicrobial Wound Gel

Company: Next Science

Website: www.nextscience.com

BlastX is a breakthrough antimicrobial wound gel powered by Next Science’s patented, nontoxic, biofilm-disruption Xbio technology. It deconstructs the bacterial biofilm’s interlocked polymeric armor (IPA), destroys the newly exposed bacteria, and defends from recolonization while maintaining a moist wound environment.

Testimonial: BlastX is the only product I know that will kill planktonic bacteria, dissolve the protective biofilm structure, kill the bacteria enveloped within the IPA, and prevent biofilm from reestablishing itself. We have used BlastX as a first-line treatment for our patients with impressive clinical results. Our patients are experiencing accelerated rates of healing similar to the published clinical data on the technology. — Jeffrey A. Niezgoda, MD, FACHM, MAPWCA, CHWS, President and Chief Medical Officer of Advancing the Zenith of Healthcare (AZH) Centers

Product: Brava Elastic Barrier Strip XL

Company: Coloplast Corp.

Website: www.coloplast.us

The NEW Brava Elastic Barrier Strip XL was created for an extra sense of security around the barrier. The Brava Elastic Barrier Strip XL supports an active lifestyle, keeping the barrier in place during physical activities. It also stays firmly in place, preventing the edges of the barrier from lifting or rolling up. The Brava Elastic Barrier Strip XL was developed with BodyFit Technology. The elasticity of the soft hydrocolloid ensures it will follow body contours and provide the extra security needed. 

To learn more about the Brava Elastic Barrier Strip XL  or to try a sample, contact your local Coloplast representative.  

Product: Coding, Payment, and Coverage Strategy and Education

Company: Kathleen D. Schaum & Associates, Inc. 

Website: kathleendschaum@bellsouth.net

Due to requests by manufactures and providers, Kathleen D. Schaum & Associates, Inc has added new services to the wound care consulting business that has been servicing the wound care community for more than 20 years. These services include new reimbursement consulting services for manufacturers that offer Advisory Board member and Product Advisory Panel participation, Executive reimbursement education workshops and strategy development consultation, sales representative and sales manager reimbursement training (beginners to advanced levels), and HCPCS application preparation. Ms. Schaum also offers new reimbursement consulting services for providers that feature reimbursement teleconsultation (planned sessions and/or “life-line” sessions) for wound care professionals and/or the entire revenue cycle team, wound care Charge Description Master review and post-review staff education, review of charges versus claims submitted versus payment/copayment received, and onsite reimbursement education (small or large groups) for wound care professionals and/or entire revenue cycle team.

Testimonials: Kathleen Schaum is one of the most knowledgeable consultants available in the fields of coding, reimbursement, and overall business operation of a wound center. Her depth of knowledge and counsel proved invaluable when we were in the process of establishing our wound care center. Kathleen was available to provide assistance and recommendations through every aspect of the startup, and her experience and insights ensured our business practices were effective, competent, and fully in compliance with state and federal regulations from the start. Kathleen’s contributions significantly assisted us in achieving our goal of a wound center providing exceptional care and service to our patients in a safe, efficient, and cost-effective manner. — Wound Center Director, Florida

Kathleen Schaum spent a full day educating our senior executives on how wound care products, procedures, and services are reimbursed throughout the continuum of care. Every team member learned so much that we felt Kathleen earned her entire consulting fee by lunchtime. Then we continued to learn for 4 more hours after lunch! Kathleen has the ability to teach a very difficult subject in a way that resonates with all who participate in her reimbursement education workshops. — Manufacturer CEO, Texas

Product:  dermaPACE System

Company: SANUWAVE, Inc.

Website:  www.sanuwave.com

The SANUWAVE dermaPACE System generates, via electrohydraulic principle, high-energy focused extracorporeal acoustic shockwaves to treat chronic skin conditions. The dermaPACE System produces tissue healing and regrowth by stimulating cellular signaling and perfusion. It is the only shockwave system cleared by the United States Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers (DFUs). The dermaPACE System produces compressive and tensile stresses on cells (micro effect) and tissue structures (macro effect), resulting in immediate and long-term microcirculatory improvements through increased perfusion due to blood vessels widening and by production of angiogenic growth factors that ultimately enhance new blood vessel formation. Microcirculatory improvements, reduced ischemia, and increased tissue growth factors produce a robust healing cascade resulting in subsequent regeneration of skin tissue. A 336-participant, double-blind, randomized controlled study based in the US using dermaPACE® to treat DFUs showed superior results in wound closure at 24 weeks for the treated group compared with a control. 

Testimonials: Dr. Maria Siemionow, Professor of Orthopedics and Director of Microsurgery Research at The University of Illinois, Chicago, said, “…in my lab experimental models, we could see directly what was happening after application of shockwaves or PACE therapy.”  

Dr. Ching-Jen Wang, Professor of Orthopedic Surgery at the Chang Gung University College of Medicine and Chang Gung Memorial Hospital, Taoyuan, Taiwan, and the former President of the International Society for Musculoskeletal Shockwave Therapy, said, “Even though we still do not know 100%, the data show shockwaves work biologically, affecting the ingrowth of neovascularization and the tissue regeneration.” 

Dr. Peter P. Balingit, an internist and DFU expert from Los Angeles County, California, and Interim Chief of Managed Care Services from Los Angeles County Department of Health Services was one of the principal investigators in the dermaPACE clinical trial. He said, “This technology stimulates angiogenesis in the limb. In a patient with diabetes, we normally have decreased blood flow to the foot. This decreased blood flow starves the tissues and causes a skin breakdown and ulcerations. By applying this dermaPACE technology, we stimulate blood flow to these starved areas, which improves wound healing. When my patients were randomized in the study, we saw a remarkable rate of closure.”

Product: DxWound

Company: Millennium Health’s genetics brand, CogenDx

Website: www.cogendx.com

DxWound is a DNA-based diagnostic tool that provides a rapid and comprehensive assessment of the microbial environment of a wound. DxWound can be used for any patient suspected of having a skin and soft tissue infection (SSTI) or with clinical signs of a SSTI. Using tiny amounts of microbial DNA as starting material, DxWound provides accurate, sensitive detection of an array of microbes, including aerobic/anaerobic bacteria and fungi, plus antibiotic resistance genes — all delivered in a single actionable report typically within 1 business day. The swab sample is collected in an inactivating solution that kills the microorganisms at the same time as protecting the microbial DNA, thus preserving the wound microbiome in time at the point of specimen collection.

Product: Endoform Antimicrobial Dermal Template

Company: Aroa Biosurgery Inc, marketing the products through Appulse.

Website: www.appulsemed.com 

Aroa Biosurgery is introducing Endoform Antimicrobial Dermal Template, marketed through Appulse. The existing extracellular matrix (ECM), Endoform Natural Dermal Template has been used in more than 2.5 million people and remains the only readily accessible ECM scaffold for the management of acute and chronic wounds. Building on Endoform’s clinical success and widespread adoption, Endoform Antimicrobial is the same ECM scaffold but with 0.3% ionic silver included to protect it against microbial colonization. Benefits include broad-spectrum protection of the dressing against a range of clinically relevant microbes, reduced toxicity, and protection for up to 7 days. As part of the Endoform family of products, Endoform Antimicrobial retains the structure of tissue ECM and includes secondary molecules (eg, laminin, fibronectin, and glycosaminoglycans) that are important to healing. The Endoform product family can be used during all phases of acute and chronic wound management, from initial stabilization of the wound bed through to remodeling and wound closure.

Testimonial: We’ve been using both Endoform and Hydrofera Blue in our wound clinic for several years with great success, so we are delighted that Appulse are continuing to make these cutting-edge products available to all our patients. Given the performance of Endoform, we are very excited to now have Endoform Antimicrobial as part of our management strategy. — Kristen, Nurse Practitioner, Virginia

Product: EXTREMIT-EASE Compression Garment

Company: AMERX Health Care Corporation

Website: AMERXHC.com

Compression therapy works but only when patients comply with the protocol. With the NEW EXTREMIT-EASE Compression Garment by AMERX Health Care, patients will appreciate the increased simplicity and comfort found in the garment, boosting adherence to protocol. The innovative design of EXTREMIT-EASE, which combines a zipper and bungees with large tabs, makes independent application and adjustment of the garment easy for patients to achieve, even patients with dexterity issues, while the lightweight, air-permeable fabric allows for hours of comfortable wear with less sweat, hot spots, or pistoning.  

PDAC-approved EXTREMIT-EASE provides 30 mm Hg to 50 mm Hg therapeutic compression and is available in regular and tall lengths for all sizes from extra small to extra large. Each garment comes with 1 garment liner and a mesh laundry bag for easy care. Increase compliance, reduce edema, and improve wound care outcomes with EXTREMIT-EASE. To learn more, contact AMERX Health Care at (800) 448-9599. 

Product: Exufiber Ag+  

Company:  Mölnlycke Health Care

Website:  www.molnlycke.us

Exufiber Ag+ is a patented, antimicrobial gelling fiber dressing. It was created based on insights from more than 500 clinicians about their day-to-day challenges when managing wounds with gelling fiber dressings. The results from this multinational survey show that more than 1 in 3 clinicians said their current fiber dressing broke up during removal and more than half said managing exudate leakage was a key challenge. Exufiber Ag+ is made using Hydrolock Technology, which locks in fluid and harmful bacteria while balancing the key features you expect in a gelling fiber dressing. The Hydrolock Technology in Exufiber Ag+ gives the dressing superior fluid retention, superior absorption under compression, and enables easy, 1-piece removal during dressing changes. Additionally, Exufiber Ag+ offers rapid, sustained, and effective antimicrobial protection from 4 gram-positive bacteria, 4 gram-negative bacteria, and 3 fungi to lower bacterial burden that may delay or prevent healing.

Product: Mepilex Border Heel (Upgraded) 

Company: Mölnlycke Health Care

Website: www.molnlycke.us

Each of the unique 5 layers of the Mepilex Border Heel serves a specific purpose, adding to its strength, durability, and absorbency. No other dressing on the market exhibits these same properties (or the published, peer-reviewed results) in pressure ulcer (PU)  prevention. The design of the Mepilex Border Heel is unique in both absorbing and distributing pressure, shear, and friction. When used for managing wounds, Mepilex Border Heel effectively absorbs and retains exudate and maintains a moist wound environment. The Safetac technology layer seals the wound edges and prevents exudate leakage onto the surrounding skin, thus minimizing the risk of maceration. The Safetac technology layer allows the dressing to be changed without damaging the wound or surrounding skin or exposing the patient to additional pain.  Upgraded features include malleoli coverage, handling tabs for easier heel checks, slightly thicker borders for easy handling, and better adhesion.

Product: Mepilex Border Sacrum (Upgraded)

Company: Mölnlycke Health Care

Website: www.molnlycke.us

Unlike other dressings, the proprietary Mepilex Border Sacrum is the only dressing with Deep Defense technology, providing an optimal balance of strength and flexibility. This not only allows the dressing to provide optimal protection against shear in combination with other extrinsic factors, but it also allows it to maintain its protective properties even with the absorption of sweat.  When used for wound management, the Mepilex Border Sacrum is designed for a wide range of exuding wounds such as sacral PUs. It also can be used on dry/necrotic wounds in combination with gels. Features that have been upgraded include wider sacral coverage, tabs for easy handling, slightly thicker borders for easier handling, and better adhesion. 

Product Name: Mölnlycke Tortoise Turning & Positioning System

Company: Mölnlycke Health Care

Website: www.molnlycke.us

The Mölnlycke Tortoise Turning & Positioning System is a unique and simple nonpowered system for positioning and offloading that is easy to use, safe for both patients and caregivers, and effective in offloading bony prominences. The low pressure air chamber adjusts to the patient’s body, evenly redistributing the pressure to offload the sacrum and greater trochanter. The characteristics of the Mölnlycke Tortoise Turning & Positioning System, which includes a low-friction mat with reinforced handles to provide an ergonomic grip, allows caregivers to easily turn and reposition the patient to the desired angle. Less strain on caregivers’ necks and backs should help reduce the occurrence of back injuries among nurses and hospital staff. The system is available in a bariatric size to accommodate bariatric-sized beds. The Tortoise Turning and Positioning System also can be used for lateral transfer of patients weighing up to 550 lb.

Product Name: Mölnlycke Z-Flex Fluidized Heel Boot

Company: Mölnlycke Health Care

Website: www.molnlycke.us

The Mölnlycke Z-Flex Fluidized heel boot has a low-profile chamber designed to maximize surface area contact and redistribute pressure from the heel and Achilles’ tendon to the whole lower leg, shin, and foot. The adjustable elastic straps allow the caregiver to adjust the boot to conform to different foot and leg sizes and shapes. The Mölnlycke Z-Flex easily converts to a flat assessment area without disturbing the patient and can accommodate sequential compression devices.

Product: Mölnlycke Z-Flow Fluidized Positioner

Company: Mölnlycke Health Care

Website: www.molnlycke.us

 Mölnlycke Z-Flo fluidized positioners offer the ability to uniquely conform to and support the patient’s body in a comfortable position until time to reposition again. The nonpowered positioners use a unique fluidized medium that is not predisposed to a particular shape. Mölnlycke Z-Flo positioners are used to offload bony prominences while maintaining neutral body alignment and are designed to remain with the patient across the care continuum. 

Product: Restrata Wound Matrix 

Company: Acera

Website: www.acera-surgical.com

Restrata Wound Matrix (Restrata) is a sterile, implantable, single-use device intended for local management of wounds. Utilizing advanced material science, Restrata’s resorbable scaffold is made from engineered nanofibers with architecture similar to the structure of extracellular matrix. This durable and flexible nanomedical scaffold supports cellular ingrowth and vascularization while resisting enzymatic degradation. Restrata’s clinical versatility allows clinicians to apply it wet or dry and to anchor it with sutures, staples, or steri-strips to ensure optimal implantation. This implantable nanomedical scaffold is commonly used in wounds, including venous leg ulcers (VLUs), DFUs, PUs, surgical and trauma wounds, partial-/full thickness wounds, and burns. 

Testimonial: A retrospective clinical study involving 70 participants/82 wounds conducted by Dr. Matthew Regulski demonstrated that 90.9% of VLUs treated with Restrata achieved completed closure at 12 weeks (and 85% of all wounds). In other published papers, 12-week closure rates in VLUs of Grafix (Osiris Therapeutics, Columbia, MD) EpiFix (MiMedx, Marietta, GA), standard of care, and Apligraf (Organogenesis, Canton, MA) were 67%, 58%, 41% and 37%, respectively.  

A prospective clinical study involving 30 participants/30 wounds demonstrated Restrata Wound Matrix closed 75% of chronic DFUs, providing comparable or superior clinical performance compared to leading skin substitute products (Grafix, Apligraf, and Oasis [Smith & Nephew, London, UK]).

Product: SenSura Mio High Output

Company: Coloplast Corp.

Website: www.coloplast.us

SenSura® Mio fits right, feels right — and now it is available in options to accommodate high output. There are 3 reasons why SenSura Mio pouching systems give patients the confidence to do more. A secure elastic adhesive follows body movements when the body bends and stretches (including in convex options), and it provides the erosion resistance required to cope with more aggressive and/or liquid output. The smooth textile material is a specially chosen neutral color designed to stay unnoticed under all clothing colors. And a specially developed full-circle prefilter provides greater protection against clogging, even with liquid output. New high output pouches include the same SenSura Mio features, now available with 2 different kinds of plug-type outlets. The standard “soft outlet” is designed for very liquid output and connects easily to a standard drain bag. Alternatively, a wider “tap outlet” provides effective drainage of thickening stool, and can be connected to a drain bag with wider corrugated tubing designed specifically for fecal output.

The new products are available in 1-piece (flat, soft convex, and convex light), 2-piece Click, and 2-piece Flex (adhesive coupling) options. To learn more about the range of options or to try a sample, contact your local Coloplast representative. 

The opinions and statements expressed herein are specific to the respective authors and not necessarily those of OWM or HMP. This article was not subject to the Ostomy Wound Management peer-review process.