Innovations That Work!

Each year for the July issue, we invite manufacturers and clinicians to salute the latest innovations in products and services. The information submitted is presented alphabetically by product. 

For ready, convenient access to comprehensive listings and information on wound, ostomy, and continence products and services, we encourage you to visit the Wounds360 Buyers Guide, available at www.wounds360bg.com. Also check your email inboxes for monthly product bulletins. As always, your comments and feedback are welcome at both the journal and Buyers Guide websites.

Product: Adapt CeraRing™ barrier ring 

Company: Hollister Incorporated

Website: www.hollister.com

Hollister® has infused its Adapt™ barrier ring with ceramide, a natural component of skin that helps protect the skin’s natural moisture barrier and helps prevent water loss that may lead to damage and dryness. Like the Adapt barrier ring, the new Adapt CeraRing barrier ring is flexible and can be stretched and shaped to help minimize the risk of leakage and protect peristomal skin. The Adapt CeraRing barrier ring is designed to support healthy peristomal skin and will be ready for sale this summer. The product was previewed at the Wound Ostomy Continence Nurses Society/Canadian Association of Enteral Therapists Conference to great feedback and excitement. 

Product: AmnioBand® Membrane             

Company: MTF Wound Care, a division of the Musculoskeletal Transplant Foundation

Website: www.mtfwoundcare.org

Wound care professionals and their patients who have struggled with acute or chronic wounds now will be able to look into an additional treatment option, AmnioBand® Membrane, a dehydrated human amnion and chorion allograft (dHACA) developed by MTF Wound Care. The emerging placental allograft contains growth factors, cytokines, and extracellular matrix proteins that work in concert with the body’s natural healing process to treat acute or chronic wounds. These key healing substances also provide a protective and physical barrier against infection and are retained through the nonprofit foundation’s aseptic processing methods. AmnioBand can be stored at ambient temperatures in a ready-to-use, package-to-patient configuration for up to 3 years, with no rehydration needed. With multiple sizes offered, AmnioBand opens up new possibilities for healing, allowing clinicians to select the graft size most appropriate to the wound while minimizing cost and waste.

Product: BioBag®

Company: BioMonde

Website: www.biomonde.com

Lucilia sericata larvae (also known as maggot debridement therapy [MDT]) have been used for centuries for debridement. Larval excretions have been shown to have a pronounced broad-spectrum antibacterial activity against a number of Gram-positive and Gram-negative bacteria and biofilms. In Europe, maggot debridement therapy is widely practiced. Despite randomized clinical trials and hundreds of publications regarding efficacy, MDT has not been adopted in the United States as part of routine wound care, likely because larval therapy has been available only as free-range where the maggots are applied directly to the wound and retained with a dressing system.  

Disinfected, living larvae are now available in a sterile polyester net bag that contains a specific number of larvae (BioBag®). This not only permits easier clinical application, but it also ensures more accurate dosing. The recommended dose of larvae is 5 to 8 per square cm when applied topically to the wound surface. Five (5) configurations of bag size and number of larvae are available. Bags may be overlapped onto the periwound area, folded, rolled into a sinus, or packed into a wound. An application of BioBag can be left in place for up to 4 days, depending on the condition of the wound. Adverse events are rare. Larval secretions can potentially cause damage to healthy skin so the periwound skin should be protected using an appropriate barrier cream or barrier dressing.

MDT provides significant cost efficiency due to the rapid treatment time. Larval therapy debrides on average with 1 to 3 treatments, with an average treatment time of 8 days. Debridement is continuous for up to 4 days, and no additional supplies other than an outer dressing are required. The literature has shown larval therapy provides faster time to debridement than sharp, surgical, and enzymatic debridement. 

Clinically, larval therapy is safe to use around bone and tendon. The literature also reports patients with diabetic foot ulcers treated with larval therapy are 3 times less likely to undergo an amputation, and limb salvage is as high as 67%, even when MDT is used as a last resort after all other interventions had failed. 

Larval therapy can be used in all areas of health care delivery. With recent advances in technology improving the application process, it is now a more viable option as a quick, safe, and cost-effective tool for wound care. — Glenda Motta, RN, MPH, Loveland, Colorado

Product: DermaPure® Decellularized Dermal Allograft 

Company: Tissue Regenix

Website: www.tissueregenixus.com  

DermaPure® Decellularized Dermal Allograft is specifically engineered to stimulate the body, not just the wound, for healing, changing the course for complex and chronic wounds. Using proprietary dCELL® Technology, DermaPure is minimally manipulated, 99% DNA-free, human-derived dermal tissue that provides pristine vascular structures and retains the native growth factors, collagen, and elastin of the tissue. The intact vascular channels of DermaPure® present before application help stimulate revascularization and allow for the natural proliferation of native cells, including attracting endothelial cells and fibroblasts.

DermaPure® provides a strong foundation for angiogenesis. It triggers healing by replacing the damaged cellular structures so the patient’s living cells can flourish to the wound and signal a natural biologic response to stimulate the body to progress through the phases of wound healing naturally.

Product: Eclypse Boot® Super Absorbent Dressing 

Company: DUKAL Corporation

Website: www.dukal.com

The Eclypse Boot® is a super absorbent dressing specifically designed to manage high levels of fluid in the lower limb. The preshaped design overcomes the traditional time-wasting complexities of dressing “leaky legs” with a combination of dressings that often are bulky and restrict patient mobility. The dressing is indicated for moderate to heavily exuding wounds including lymphedema, leaky legs, arterial ulcers, diabetic ulcers, leg ulcers, superficial wounds, and pressure ulcers. Wear time depends on the level of exudate and daily changes may be required, but Eclypse Boot® can be left in place for up to 7 days. Three (3) sizes are available.

Testimonial: We have been using the Eclypse Boot® in our busy wound healing center for a few months now, mainly with venous leg ulcer patients experiencing heavy drainage. I have observed the boot consistently and successfully manage heavy drainage levels and reduce dressing change frequency and supply costs. Patients love this product because they find it improves their quality of life by allowing more normalcy day-to-day. The Eclypse Boot® has made a huge improvement in many of our patients’ lives, and I would recommend it to other clinicians treating patients with these wound conditions. — Holly Swan, RN, BSN, CWS, Alexian Brothers Wound Healing Center, Elk Grove Village, Illinois

Product: In development

I have devised a wearable force pressure and vacuum sensor based on a resilient foam. It communicates pressure or vacuum information in mm Hg to a smartphone. The sensor is small (1 to 16 in²) and is packaged within an airtight nontoxic polyethylene shell under vacuum. Potential applications include verifying, displaying, and/or instructing:  1) compression stocking strength; 2) pressure under compression wraps; 3) pressure from hook-and-loop closures to control lymphedema and prevent new leg ulcers; 4) spot-check of vacuum strength from a negative pressure device near the bandage; 5)  a measurement of force (eg, in lb) to serve as a manual muscle tester or isometric strengthener giving feedback of performance; and 6) limb load monitor for orthopedic protected weight bearing. It is at the prototype stage, with patents pending. The author would entertain potential interest in the product.  —Robert Goldman, MD, ABPMR, ABPM, CWS, Medical Director, Wound and Hyperbaric Center, Fort HealthCare, Fort Atkinson, Wisconsin 

Product: iOn HEALING™ Mobile App 

Company: Acelity

Company Website: www.acelity.com 

iOn HEALING™ Mobile App Website: www.ionhealingapp.com  

The iOn HEALING™ Mobile App, designed and developed by Acelity, allows wound care clinicians to do their job more easily than ever before by managing key Acelity interactions while on the go. A pioneering solution in its class, the iOn HEALING™ App represents a leap forward in workflow optimization and puts powerful features at the clinician’s fingertips. The app allows users to record and send wound assessments, order V.A.C.® Therapy and Dressings, and seek in-app consults to discuss potential treatment options. More than 2,500 clinicians have downloaded the iOn HEALING™ App since it was first introduced in May 2015. 

The iOn HEALING™ App is built on the premise that security and convenience should work hand-in-hand. This HIPAA-compliant platform keeps protected health information (PHI) secure by leveraging a suite of industry-class security features, including encryption of data in motion and at rest, secure authentication, and smart data management. PHI privacy and security are maintained in an unbroken chain from the smart device to secure Acelity servers. In addition, the iOn HEALING™ App is officially certified by NowSecure™, a mobile security forensics company that assesses certification applicants against an exhaustive vulnerability audit. 

The app can be downloaded for free and is available on both iOS and Android tablets and phones. Future versions are in the works and will include expanded ordering capabilities and a Wound Care Product Selection Guide.

Product: InteliShield™ Barrier Film

Company: Vancive Medical Technologies

Website: https://vancive.averydennison.com

Barrier films for ostomy applications are expected to be discreet for the patient, cost effective to produce, and ecofriendly. Innovative research and development has led to the creation of complex composites — “intelligent” barrier films that can deliver structural integrity plus a host of added qualities and characteristics. 

The multilayer structure of this recently developed barrier film is designed to provide patient comfort. An oxygen barrier layer helps control odor while other layers provide enhanced strength and secure bonding. A nonleaching antimicrobial agent on the film’s inner surface also can kill bacteria quickly to help reduce odor. This agent remains active as the ostomy bag fills but will not enter the body via the stomach or leach into the bag contents. Through a combination of plastics, this barrier film also is quiet and flexible, even without the use of plasticizers to soften it. All of these qualities — softness as well as odor and noise control — are crucial to the patient’s quality of life. 

The absence of plasticizers in barrier materials can help reduce the risk of health complications caused by di-(2-ethylhexyl) phthalate (DEHP), the main plasticizer for polyvinyl chloride (PVC), which is known to leach into ground water and can have a negative impact on human health. Barrier films for ostomy applications can be made from materials that are less damaging to the environment than traditional films. These films are free of PVC, polyvinylidene chloride (PVdC), and plasticizers. 

In addition to being safer for the environment and human health, plasticizer-free barrier films have economic benefits. They are made from materials that can offer more cost-effective disposal of intermediate scrap. The films still can be sealed using common manufacturing techniques (eg, heat, heat impulse, and radio frequency welding), giving manufacturers the ability to choose the technique that is best for the final product. These factors are relevant as the health care industry strives to control costs amid tighter reimbursement rates for some ostomy products.

Product:  Interfyl™ Human Connective Tissue Matrix

Company: Alliqua® BioMedical, Inc.

Website: www.alliqua.com

Interfyl™ Connective Tissue Matrix is an allogeneic, decellularized particulate human placental connective tissue matrix consisting of natural human structural and biochemical extracellular matrix components. The transplanted matrix retains its fundamental structural and functional characteristics of connective tissue extracellular matrix, providing mechanical/structural support and elasticity. Interfyl provides a framework for incorporation by the recipient’s tissues and cells. It is intended for use as the replacement or supplementation of damaged or inadequate integumental tissue.

Product: Kerecis™ Omega3 

Company:  Kerecis LLC

Website:  www.kerecis.com

Kerecis™ Omega3 Wound is a piscine skin acellular dermal graft. The omega3-rich, full-thickness, decellularized fish skin material accelerates wound healing and enables tissue reconstruction. With the only comparative, double-blinded, randomized, controlled trial (RCT) in wound care and more than 10,000 applications globally, Kerecis has demonstrated fast healing times, especially with hard-to-heal wounds, including those with exposed bone and tendon.  

 Because there is no risk of viral transfers, Kerecis’ production process leaves in the natural omega3 fatty acids, which have anti-inflammatory and bacterial barrier properties. 

 Kerecis™ Omega3 Wound is easy to apply, has a long shelf life, and does not require additional grafting material. There are no cultural and religious sensitivities to using Kerecis™ Omega3 Wound as there can be with porcine-, bovine-, and other mammalian- or human-sourced materials.

 The United States Food and Drug Administration-approved technology is patented in the US and multiple other countries, the product has a Medicare “Q” code (Q4158) that facilitates reimbursement by Medicare and private insurance companies, and it is on the Federal Supply Schedule.

Product: KerraMax Care

Company: Crawford Healthcare

Website: www.crawfordhealthcare.com

Testimonial: An increase in moisture-associated skin damage and folliculitis often occurs under total contact casts (TCC). TCCs are left in place for a week and most of these patients are still active and working. The patients appear to develop skin breakdown secondary to sweating. We tried several different ways to pad or protect the skin with different skin protectants, and dressings but were unsuccessful. We finally found a product that worked: the superabsorbent dressing KerraMax Care. Depending on the size of the leg, the product was placed on the anterior shin and on the posterior calf to completely envelop the leg. Next, we wrapped the lower leg with a cotton roll and applied the TCC. After implementing this practice, we saw a dramatic decrease in the amount of MASD and folliculitis in our patients. — Emily Greenstein, BSN, RN, CWON

Product: MEDIHONEY HCS Surgical and Fenestrated Dressings 

Company: Derma Sciences, Inc

Website: www.dermasciences.com/medihoney

The new MEDIHONEY® HCS Surgical and MEDIHONEY® HCS Fenestrated dressings combine the wound healing benefits of medical-grade honey with super absorbent polymer (SAP) exudate management technology to offer a versatile and dynamic dressing solution for your patients’ needs. The dressing benefits include promoting a moisture-balanced environment optimal for wound healing; supporting autolytic debridement and the removal of necrotic tissue containing factors that can delay wound healing; an association with lower pH levels within the wound, which has been shown to have wound healing benefits; providing optimal absorption and fluid handling capability; visibility to the wound (transparent); and delivering a soothing, cooling effect on application.

Testimonial: Use of MEDIHONEY® HCS Fenestrated postsurgically on patients undergoing deformity correction with open reduction internal fixation has shown to be clinically effective in my practice. This novel dressing helped protect and provide an optimal moist environment surrounding the pin sites, promoted a continual autolytic debridement that keeps pin sites clean and demonstrated optimal healing rates without common complications. — Michael S. Kerzner, DPM, Duke University Wound Management Center, Durham, North Carolina 

Product: MED SAF 

Company: ManukaMed USA

Website: ManukaMdUS.com

MED SAF is a wound dressing from the makers of MANUKA HD and HD Lite, the highly potent medical-grade Manuka honey wound dressings. MED SAF is comprised of a blended, superabsorbent, cross-linked gelling fiber mesh. It is effective for heavily exuding wounds. The dressing expands as the fibers absorb and the gel helps remove the exudate. The dressing is applied directly to the wound and covered with an appropriate secondary dressing. It may be changed daily as needed. Flexible and comfortable, the dressing is available in 2 sizes: 4 in x 5 in and 4 in x 39 in. 

Product:  Mepilex XT 

Company: Molnlycke Health Care

Website: www.molnlycke.us

Exuding wounds are a tough challenge for patients and clinicians. Mepilex XT is a breakthrough in wound care. The product is a foam dressing designed for a wide range of exuding acute and chronic wounds in all healing stages. Proven to handle large amounts of exudate quickly, the dressing features exudate management channels that absorb both low- and high-viscosity fluid, drawing it away from the wound bed. Because it can handle all types of exudate (low to high viscosity), Mepilex XT can be used confidently at any exuding wound healing stage, including sloughy wounds. Mepilex XT also contains Safetac, a technology designed to minimize pain and trauma at dressing change and reduce the risk of maceration to the periwound skin.

Testimonial:  Mepilex XT, with its unique exudate channels, provides an alternative dressing for the difficult-to-heal patients with highly viscous drainage we see in our Resident Clinic. We have been using this product under compression and found the thick drainage is wicked away from the patient’s skin via these larger channels, which helps protect the periwound skin. In addition, because of its absorbency, the dressing has decreased the frequency of dressing changes. Our patients love the comfort of the dressing, the painless removal of the dressing, and how nicely they are healing. —

Suzanne Koerner BSN, RN, CWOCN; Diane Adams BSN, RN, CWCN, Mount Carmel West, Columbus, Ohio

Product:  Mextra Superabsorbent 

Company: Mölnlycke Health Care

Website: www.molnlycke.us

Mextra Superabsorbent is intended for use on wounds with moderate to heavy exudate. Its performance in exudate management and supporting wound healing is the key to delivering positive outcomes. Mextra Superabsorbent’s 4-layer construction works in a precise sequence to deliver optimal exudate management;  its hydrophilic wound contact layer is gentle to the periwound skin. The distribution layer directs exudate evenly upward into the absorbent layer, which comprises optimal amounts of fibers and superabsorbent particles that bring about outstanding absorption and retention. The absorbent layer does not become bulky or disintegrate upon exudate absorption, allowing the dressing to remain dry and comfortable for the patient. The fluid-repellant backing layer minimizes strikethrough and keeps the outer layer dry. Mextra Superabsorbent has matrix metalloproteinase modulating properties and provides a conducive environment for wound healing to proceed.

Product: NEOX® Wound Allograft

Company: AMNIOX Medical Inc

Website: www.amnioxmedical.com

Testimonial: At our wound center, which treats more patients than any other wound center in the tristate area of New York, New Jersey, and Connecticut, we aggressively treat wounds complicated by osteomyelitis by using human umbilical cord (UC) to modulate inflammation and promote healing. 

UC tissues protect the fetus from immunological insult and injury while in utero and naturally exhibit unique anti-inflammatory biological properties. A critical protein signaling factor, heavy chain hyaluronic acid/pentraxin 3(HC-HA/PTX3) complex, constitutively expressed within UC, imparts the anti-inflammatory and regenerative effects seen clinically with the use of these tissues. HC-HA/PTX3 takes direct action on pro-inflammatory cells at every level of the inflammatory process. This signaling complex selectively induces apoptosis of activated neutrophils and macrophages and suppresses T-cell activation by inhibiting proliferation while downregulating pro-inflammatory cytokines. Cryopreserved UC tissue retains high levels of HC-HA and PTX3. When implanted in a wound, UC skin substitute transfers the regenerative healing properties found in the fetal environment and alters the adult healing response of inflammation and scarring to one of anti-inflammatory regeneration. The cryopreserved UC (cUC) matrix (NEOX® Wound Allograft), which is composed of both UC and AM, is implanted and stapled in place to ensure direct contact with the wound bed. 

In an IRB-approved retrospective study conducted by our center to examine the effectiveness of cUC in healing lower extremity ulcers complicated by osteomyelitis (N = with 33 wounds and a diagnosis of osteomyelitis), we achieved a 78% healing rate, with a mean time to closure of 16.02 weeks. — Wayne J. Caputo, DPM, Clara Maass Medical Center, Belleville, New Jersey

Product: PuraPly™ and PuraPly™ Antimicrobial (AM)™

Company: Organogenesis Inc

Website: www.organogenesis.com

PuraPly™ and PuraPly Antimicrobial (AM)™ are comprised of a purified collagen matrix with polyhexamethylene biguanide (PHMB); they are United States Food and Drug Administration-, 510(k)-cleared Class II medical devices approved for acute and chronic wound management across a wide variety of wound types, including partial-thickness  and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, and venous and diabetic ulcers. PuraPly™ products can be used on most wounds seen by clinicians, and PuraPly™ AM™ provides physicians a new option for wounds with a high degree of bioburden. PuraPly and PuraPly™ AM™ have been approved for pass-through reimbursement in the hospital outpatient setting by the Centers for Medicare and Medicaid Services.

The results of 3 studies were presented at the Symposium for Advanced Wound Care, in Atlanta, GA, April 13–17, 2016. The first assessed PuraPly™ AM’s ability to reduce proliferation of methicillin-resistant Staphylococcus aureus (MRSA) in deep, partial-thickness wounds in pigs over a 3-day period compared to a commonly used silver-based dressing; less MRSA was recovered when PuraPly™ AM™ was used. The second study was a case series involving a diabetic foot ulcer, a pressure ulcer, and a surgical wound that demonstrated successful management of bioburden allowed wounds to progress to closure. The third study showed PuraPly was effective in managing 3 different types of wounds previously unresponsive to standard care.

Product: PureWick Female Urinary Incontinence Management System

Company: PureWick, Inc. 

Website: www.PureWick.com

PureWick is a new incontinence management solution for women (usually bedbound) who have difficulty getting to a toilet. It is composed of an elongated tube wrapped in wicking material and attached to a continuous vacuum source. The PureWick is tucked externally between the labia and the gluteal cleft approaching the anus, with the wicking side of the PureWick facing toward the midline of the body. Tubing connects the PureWick to a continuous vacuum, and urine output is collected in a 1000-cc to 2000-cc urine collection jar, which features an overflow shutoff valve to prevent urine capture from exceeding the volume of the container. Wicks are replaced after 8 to 12 hours, generally in the morning when the patient awakens. A series of case studies reported few adverse events (dislodgement or skin irritation from positioning dressings), and no urinary tract infections resulted from use. 

Testimonial: PureWick was selected San Diego’s Most Innovative Product in the Medical Device and Pharmaceuticals Category for 2015.

Product: TRIACT™ Foam with Silicone Border 

Company: Hollister Incorporated

Website: www.hollister.com

TRIACT™ foam with silicone border combines the benefits of a silicone border with the TRIACT™ wound interface layer. The periwound deserves silicone, the wound deserves better. TRIACT™ technology, a lipido–colloid matrix containing carboxymethyl cellulose particles, forms a gel in the presence of exudate. This gelling action helps provide a moist, wound healing environment; helps minimize pain at dressing change; and helps prevent damage to newly formed tissue during dressing removal. The reduction of pain at dressing change due to the TRIACT™ interface was demonstrated in the MAPP study, where on 1879 patients, TRIACT™ wound contact layer reduced pain during dressing changes in 88% of patients with chronic wounds and 95% of patients with acute wounds.

TRIACT™ foam with silicone border also provides excellent fluid handling, with the added benefit of pressure redistribution and reduction in contact pressure. 

Testimonial: I trialed the new TRIACT™ foam with silicone border for the first time in January 2016. Like many clinicians, I tried it first on a “nightmare” wound. My patient was an elderly woman in palliative care, suffering from breast cancer with skin metastasis. She complained of frequent pain on dressing removal, odor from the dressing, and frequent periwound skin tears from adhesive products. She reported several benefits after her first dressing change with TRIACT™: when the dressing was in place, there was no odor, the dressing stayed in place for 2 days without leakage (a first for her), there was minimal pain on removal, and her periwound skin stayed intact. An added bonus was the conformability of the dressing. Her wound is located in her right axilla, and previous dressings limited her range of motion. The TRIACT™ dressing conformed to her skin contours and allowed for free range of motion without pain. This dressing provided great comfort and improved quality of life during the end of this patient’s life. These results are priceless. — Kimberly LeBlanc, MN, RN, CETN(C), PhD (student), and Co-chair, International Skin Tear Advisory Panel, Ottawa, Ontario, Canada