Innovations That Work!

Every July for your summer reading pleasure, the editors and staff of Wound Management & Prevention invite wound, ostomy, and continence product manufacturers to tout their wares. The products are listed alphabetically. In addition, our Editorial Board members were asked to weigh in on products of note they discovered at SAWC Spring and describe products and care plans they currently use. We hope you find this information useful and invite you to add your own comments online following the article and on our social media sites. 

Product: Ankle Keeper
Company: Ulcer Solutions
Website: www.ulcersolutions.com

The Ankle Keeper is an effective, discreet, comfortable, physician-designed ankle offloading device that prevents and treats pressure ulcers of the ankle bones (malleoli). The device is an elastic ankle sleeve with a removable U-shaped foam cushion located over the malleoli. The cushion is uniquely designed to allow return of interstitial fluid in the physiologic direction toward the heart. The rounded cushion reduces “edge effect” and increases comfort; the sleeve is comfortable and easily donned. The device allows complete freedom for ambulation and mobility in bed, can be worn with most shoes, and is nearly invisible when worn under pants. The Ankle Keeper provides enhanced compliance and safe ambulation while effectively offloading the ankle and maximizing patient mobility. It is the only device specifically designed for offloading the malleoli, fits the left or right foot, is made of washable and antimicrobial materials, and comes in 4 sizes.

Testimonial: The Ankle Keeper has been my best option for active/inactive patients who have ulcers of the medial and lateral malleoli. The Ankle Keeper stays in the correct position to properly offload the wound, is easy for my patients to put on and take off, and is cost effective. More importantly, the Ankle Keeper is an offloading device my patients will wear consistently to properly offload their ankle wounds. — Antonio J. Carrasco, PhD, MD

Product: Colosafe
Company: International Medical 
Technology (IMT)
Website: www.imt-us.org

Colosafe is a new pouchless device for patients with a colostomy or end ileostomy. Colosafe helps eliminate carrying a pouch 24/7, skin irritation, adhesive use, and narrowing of the stoma and also prevents leakage and odor. The device stays in place for up to 28 days. Colosafe has been well-received by patients who are comfortable and confident in performing daily activities. 

Product: Comfort Release
Company: Global Biomedical Technologies
Website: www.comfortrelease.com

Global Biomedical has developed and patented the first smart and switchable medical adhesive for optimal water-resistant adhesion combined with the benefit of completely pain-free removal. Comfort Release is made with a unique polymer built into the bandage’s adhesive backing. A simple swipe with rubbing alcohol helps release the stickiness so you can “turn off” the adhesive and remove it without pain or discomfort. Comfort. Release. Our center transparent window dressings are made of thin polyurethane material with a low level of adhesion; they are waterproof and highly breathable for better wound healing and skin health. The border areas are made of a nonwoven film with a strong acyclic adhesive triggered with our easy-release polymer. Our border adhesive foam dressings have a hydrophilic foam pad in the center made of soft foam, which is comfortable, conformable, highly absorbent, breathable, and capable of expanding up to 50% when fully saturated. 

Testimonial: With Comfort Release, I have the confidence that my management of a wound will not create another wound. And with that confidence, I can invest more care and time into my patient’s treatment and recovery. When they say my name and sincerely tell me “thank you,” that is the best feeling of all! — Debbie M, occupational therapist

Product: Excellagen 
Company: Olaregen Therapeutix, Inc.
Website: www.olaregen.com

Excellagen is a United States Food and Drug Administration (FDA)-cleared, native fibrillar collagen (2.6%) wound conforming matrix intended for physician use in the management of acute and chronic dermal wounds. Excellagen is engineered to support a favorable wound healing environment and promote rapid healing. It is recommended that Excellagen be applied after surgical debridement in the presence of a small influx of blood, which will immediately activate human platelets, triggering the release of growth factors to accelerate healing. The product is available in 3 sizes: 0.5 cc, 0.8 cc, and 3.0 cc. Excellagen should not be used in patients with known sensitivity to products of bovine origin.

Product: Exufiber Ag+
Company: Mölnlycke Health Care
Website: www.molnlycke.us

Exudate Leakage. Maceration. Infection. Key challenges for gelling fiber dressings, which can impact healing, cause anxiety and pain for the patient, and take up nurse time.¹

Exufiber Ag+ with Hydrolock Technology has superior ability to lock in exudate, even under compression; stays intact for clean, 1-piece removal; and provides antimicrobial effect in the dressing.^2–7 By keeping exudate locked in, staying intact during dressing changes and delivering effective antimicrobial action in the dressing, Exufiber Ag+ can support undisturbed healing as well as a potential reduction in costs.^2-3,5-6 Exufiber Ag+ is a nonwoven polyvinyl alcohol dressing that transforms into a gel upon contact with exudate, helping it softly conform to the wound bed.^8-9 The dressing absorbs and locks in exudate, blood, and bacteria^2-4,10-11 in addition to having high retention capacity to prevent leakage and maceration.^2,3 Controlled release of silver ions within the dressing when in contact with wound fluid provide antimicrobial action for up to 7 days (in vitro).⁶

References

1. Mölnlycke Health Care data: Veeva Survey undertaken in UK, Sweden, Denmark, Finland, Norway and Latvia between September 2014 and July 2015. Report PD-532221. Data on file.

2. Mölnlycke Health Care Laboratory Report PD-520425. Data on file.

3. Mölnlycke Health Care Laboratory Report PD-556978. Data on file.

4. Mölnlycke Health Care Laboratory Report PD-521232. Data on file.

5. Mölnlycke Health Care Laboratory Report PD-521248. Data on file.

6. Hamberg K, et al. Antimicrobial effect of a new silver-containing gelling fiber dressing against common wound pathogens. Poster presented at: Symposium on Advanced Wound Care/Wound Healing Society (WHS) Spring; April 5–9, 2017; San Diego, CA. 

7. Mölnlycke Health Care Laboratory Report PD-505602. Data on file.

8. Davies P, McCarty S. An in-use product evaluation of a gelling fiber dressing in wound management. E-poster presentation at Wounds UK Conference; November 13–17, 2017; Harrogate, United Kingdom.

9. Lev-Tov, et al. An interim analysis of clinical investigation to evaluate exudate management and comfort of use of an antimicrobial gelling fiber dressing in medium to highly exudative wounds. Poster presented at: Symposium of Advanced Wound Care Fall; November 2–4, 2018; Las Vegas, NV. 

10. Mölnlycke Health Care Laboratory Report PD-522900. Data on file.

11. Mölnlycke Health Care Laboratory Report PD- 521245. Data on file. 

Product: GrafixPL PRIME
Company: Osiris Therapeutics, Inc.
Website: www.Osiris.com

GrafixPL PRIME (lyopreserved placental membrane) is a lyopreserved amnion matrix retaining the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts, and epithelial cells of the native tissue. GrafixPL PRIME naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule, and muscle. GrafixPL PRIME may be used to repair acute and chronic wounds, encompassing both upper and lower extremity, including, but not limited to, diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, burns, acute surgical wounds, pyoderma gangrenosum, and epidermolysis bullosa. The product is limited to homologous use as a wound cover/wrap/barrier. 

Product: Heel Keeper
Company: Ulcer Solutions
Website: www.ulcersolutions.com

The Heel Keeper is a comfortable, compliance-enhancing, fall risk-reducing substitute for traditional offloading boots used in the treatment and prevention of pressure ulcers of the heels and ankles. The physician-designed, calf-cradling cushion floats the heel above the resting surface. The contour of the cushion gives relief and protection for the Achilles tendon. Because the foot is unencumbered, walking and standing are easy and safe. Foot inspection and dressing changes can be performed without removing the device. Compression or sequential compression devices can be worn with the device as well. Two (2) removable nonroll wedges are included. The device is made from washable and antibacterial material. Most importantly, patient compliance is enhanced with fewer pressure ulcers, quicker healing, and significant cost savings. The device is available in Standard and XL sizes (US Patent Pending 62/630,723, 62/637,053).

Testimonials:

I strongly recommend the Heel Keeper for use in a variety of settings, including home, hospital, skilled nursing facility, operating room, and any setting where the patient is at risk for developing a pressure ulcer. Heel ulcers are a major problem, and despite the products and methods that are routinely used to offload heels, none have been found to adequately address all areas of concern. Several heel protectors on the market have been shown to create new pressure wounds, while most simply do not provide what they claim to do, namely reduce pressure at the heel. Dr. Finley’s design addresses critical factors, including anatomy and the physical issues surrounding an immobile patient. I have personally worn a Heel Keeper and found it to be very comfortable. Patient compliance is an issue with many of the other “heel protector” products. As a physician who has dedicated his professional life to reducing unnecessary suffering and amputations, I hope clinicians will consider using this important product. — Desmond Bell, DPM, CWS

I am the director of nursing at a 120-bed skilled nursing facility. We frequently care for complex patients with or at high risk for pressure injuries. In my experience, the utility of traditional offloading boots is limited due to patient noncompliance. The Heel Keeper is different. The primary benefit of the Heel Keeper is compliance; patients are much more likely to wear the Heel Keeper. I have not seen any ulcers develop in patients where it was used prophylactically and have noted rapid healing when used for existing ulcers. The Heel Keeper’s effectiveness has been rather startling. An additional major benefit is the reduction in fall risk. Patients can easily walk while wearing the Heel Keeper. I highly recommend the Heel Keeper for patients at risk for heel or ankle ulcers, especially those with cognitive deficits. — Dave Brantley, BSN, RN

As a nurse with 40 years’ experience, I say kudos for a low-cost, lightweight, comfortable, single-patient use (I send it with the patient on discharge to the skilled nursing facility) device. It is much more stable and user-friendly than any other offloading product I have seen. Well done! — Matthew W. King, RN-BC, BSN, MSN

Product: InterDry
Company: Coloplast
Website: www.coloplast.us | www.interdry.com

InterDry is an innovative moisture-wicking fabric with antimicrobial silver that effectively manages skin damage associated with skin-to-skin contact. It prevents further skin damage from occurring so patients can be active, comfortable, and confident all day.

Testimonial: I cannot think of a single reason you would not add InterDry to  your skin care formulary. It is simple, cost effective, and the only product that works. — Joyce M. Black, PhD, RN

Product: Mepilex Border Flex
Company: Mölnlycke Health Care
Website: www.molnlycke.us/MBFlex

Mepilex Border Flex stays on and uniquely conforms thanks to innovative Flex Technology, which allows the dressing to move in every direction, reducing skin stress, increasing comfort,^1-3 and keeping it in place. It also has smart exudate management: the 5-layer dressing absorbs, channels, and traps exudate and, according to in vitro studies, allows you to track progress. It also keeps exudate-containing bacteria from the wound bed and minimizes re-entry, even under compression.⁴ Our proven Safetac technology means less pain and trauma to the skin⁵ during dressing changes and reduced risk of maceration compared to traditional (adhesive) dressings.^6,7 Finally — a silicone dressing that conforms and stays on — Mepilex Border Flex.

References

1. Mölnlycke Health Care. Report no. PD-529747. Data on file. 

2. Mölnlycke Health Care. Report no. PD-534569. Data on file. 

3. Mölnlycke Health Care. Report no. PD-534571. Data on file. 

4. Mölnlycke Health Care Report no. PD-537072. Data on file. 

5. White R. A multinational survey of the assessment of pain when removing dressings. Wounds UK. 2008;4(1):14–22. 

6. Woo K, Bergström C. Clinical Investigation Report (MXB408, Part A, Mölnlycke Health Care), 2007. 

7. Meaume S, Van De Looverbosch D, Heyman H, Romanelli M, Ciingherotti A, Charpin S. A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound Manage. 2003;49(9):44–51.

Product: MicroLyte Ag Matrix 
Company: Imbed Biosciences
Website: www.MicroLyteAg.com

MicroLyte Ag Matrix is an ultrathin polymeric film with a proprietary nanocoating containing antimicrobial ionic and metallic silver, suitable for use on virtually all wound types (ie, surgical, traumatic, or chronic). MicroLyte Ag Matrix brings a one-of-a-kind combination of characteristics in a wound care product:

• Fully resorbable: MicroLyte Ag Matrix never needs to be removed from the wound, reducing painful dressing changes;
• 3-day antimicrobial effect: MicroLyte Ag Matrix is >99.99% effective against a broad spectrum of wound-related microbes;
• Synthetic: MicroLyte Ag Matrix carries zero risk of disease transmission; and
• Safe: MicroLyte Ag Matrix has a lower but effective level of ionic and metallic silver that reduces harm to healthy tissues.

The combination of these characteristics means that MicroLyte Ag Antimicrobial Matrix can be your first choice for wounds.

Product: MolecuLight i:X
Company: MolecuLight Inc.
Website: moleculight.com

MolecuLight offers point-of-care solutions for wound care diagnostics. The MolecuLight i:X allows clinicians to visualize fluorescence in real-time and measure wounds automatically. In clinical studies, the MolecuLight i:X has been shown to detect bacteria at moderate-to-heavy loads,^1,2 improving wound assessment and helping clinicians make evidence-based treatment decisions. This allows for more targeted treatment protocols by mapping fluorescence emitted from biological sources (including bacteria^1-3) and nonbiological sources.

Recent clinical trials involving more that 350 wounds from 14 sites and 20 clinicians found fluorescence images had 3-fold higher sensitivity than clinical signs and symptoms for detecting moderate-to-heavy bacterial loads and facilitated improved treatment decisions and antibiotic stewardship.^2,3

The MolecuLight i:X is now FDA-cleared and is distributed directly by MolecuLight Inc in the US. MolecuLight is making dramatic inroads to improve wound care throughout North America and Europe.

References

1. Rennie MY, Lindvere-Teene L, Tapang K, Linden R. Point-of-care fluorescence imaging predicts the presence of pathogenic bacteria in wounds: a clinical study. J Wound Care. 2007;26(8):452-460.

2. Serena T, Harrell K, Serena L, Yaakow R. Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden. J Wound Care. 2019;28.

3. Serena T. Bacterial fluorescence image guidance of antimicrobial decision making and stewardship. Poster presented at: Symposium on Advanced Wound Care; May 7–11, 2019; San Antonio, TX.

Testimonials:

The MolecuLight i:X has transformed my clinical decision making. MolecuLight i:X shows me concerning levels of bacteria in the wound, which helps reveal the unexpected and eliminates guess work. — Rosemary Hill, BSN, CWOCN, CETN(C) 

The MolecuLight i:X gives clinicians the ability to visualize and, therefore, target treatment toward clinically undetectable critical colonization. This user-friendly, point-of-care device is an exciting addition to our wound care protocol. — David Russell, MD 

The MolecuLight i:X completely changed my decision-making and resulted not only in time and cost savings, but also in improved patient outcomes. — Lt Col Steven Jeffery 

Product: PolyMem Silicone Border
company: Ferris Mfg. Corp.
website: polymem.com/silicone

We’ve combined a gentle adhesive option with the same proven PolyMem formulation for a more comfortable experience that is ideal for patients with fragile or sensitive skin. PolyMem works synergistically with the body to control inflammation, reduce pain, and increase healing. PolyMem is indicated for use on virtually all types of wounds. PolyMem has been shown to close wounds that failed to progress using best practices.

Product: SkinTE 
Company: PolarityTE
Website: https://www.polarityte.com/

SkinTE is a cellular- and tissue-based autologous, homologous cutaneous construct that uses a small sample of skin to cover a large wound area and does so with minimal harvest-site morbidity. It is the first and only FDA-registered product capable of regenerating functionally normal skin for skin repair, reconstruction, replacement, and supplementation. SkinTE has been proven to regenerate full-thickness skin with all layers (epidermis, dermis, hypodermis) and appendages. Treatment with SkinTE has also produced function (sensation, sweat, pliability) and histology comparable to native skin, while limiting contracture, all of which may improve quality of life. 

Testimonial:

We started using SkinTE about 3 or 4 months ago on patients’ tougher wounds. All of the foot ulcers healed with SkinTE along with standard wound care, improvements in blood sugar levels, and taking weight off the affected foot as much as possible. For patients with diabetes where the healing process is impaired or a patient who is immunocompromised, SkinTE is the wave of the future. — Dr. Steven Frania 

Linen for pressure injury prevention. Debrisoft (L&R USA, Milwaukee, WI); edema garments (Tactile Medical, Minneapolis, MN); and Tamarack Glide wear (Blaine, MN)  — Linda Droste, MSN, RN, CWOCN, CBIS

Parasol Medical LLC (Buffalo Grove, IL) and KCI, an Acelity Company (San Antonio, TX) have a silicone drapes available. This is a huge innovation for our patients, because it helps us use less pain medication and pain reduction strategies at negative pressure dressing changes. Additionally, the finger/toe dressing also appeared to be innovative. — Cathy Milne, MSN, APRN, CWOCN-AP

The fecal collecting device Qora from Consure Medical (San Francisco, CA), and new support wheelchair cushions and great tape that resticks that you use for C-pap machines from Frontier Therapeutic LLC (Seattle, WA). — Karen Kennedy-Evans, RN, FNP, APRN-BC

Venous issue prevention: The geko device is a unique neuromuscular stimulator indicated for reduction of postoperative edema and stimulation of the calf muscles to prevent deep vein thrombosis. It is also being studied in terms of increased blood flow and the impact on healing of certain wound types. It is recommended for use in the UK, especially for patients at high risk of venous thromboembolism (VTE) for whom standard methods of VTE prevention are impractical or contraindicated. — Glenda J. Motta, RN, MPH 

Pressure ulcer prevention/treatment: Prominent program at our facility: pressure ulcer prevention and treatment. This includes all ages and varied practitioners (RN, NP, PA, MD/DO). It is not a product guide, it is a clinical management care path. — Evan Minior, MSN, ENP, FNP-BC

Nutrition ideas: 

We use nutrition products from Medtrition (Lancaster, PA) in acute rehabilitation patients with good results:

• • Management of diarrhea (Clostridium difficile, tube feeding, prophylactic antibiotic treatment): Banatrol Plus. Start with 1 pack every 6 or 8 hours for tube feeding, twice or 4 times a day for oral intake (use only the natural banana flavor). For small g or all J-tubes to avoid risk of clogging the tube, use PreB2 twice a day;
• For diabetic leg wounds and pressure ulcers, GelaTein20 at noon and ArgiTein twice a day. GelaTein contains 20 g of collagen protein/4-oz cup, comes in regular and sugar-free, and is safe for dysphagia diets;
• ArgiTein, a sugar-free powder with 4.5 g of arginine and 5 g of whey protein. — Evelyn Phillips, MS, RD, LDN, CDE

Juven (Abbott Industries, Chicago, IL) has been reformulated to include vitamins and minerals. — Nancy Collins, PhD, RD, LD/N, FAPWCA

Moisture-associated damage: Comfort Shield Cloths by Stryker Corporation (Kalamazoo, MI) are easy to apply, cost effective, and prevent and heal moisture-associated skin damage remarkably well. — Michelle Barakat-Johnson, RN, Cert Pain Management, GDip Rehab, M Nursing, PhD

Wound prevention and management: My regimen: I am currently working with Vizient and Hospital Innovation and Improvement Network partners on advancing patient engagement and the use of Patient, Family Advisory Councils (PFAC) in pressure injury prevention programs utilizing Prontosan (B. Braun Medical, Inc, Bethlehem, PA) (helps with biofilm); Hydrofera Blue (Aora, Auckland, New Zealand)(conforms to wound shape, decreases bacteria, and absorbs well; Apligraf (Organogenesis, Canton, MA); Oasis (Smith & Nephew, London, UK); and occasionally Epifix (MiMedx, Marietta, GA). — Eliot N. Mostow, MD, MPH

Compression: Pneumatic compression pumps combined with short-stretch bandaging used 2 to 3 times per week.  — Joseph McCulloch, PhD, PT, CWS, FAPFA

Negative pressure options: The new KCI (an Acelity Company, San Antonio, TX) sponge options. — Evan Minior, MSN, ENP, FNP-BC

The plan of care for pressure ulcer prevention in spinal cord patients should include interdisciplinary team/nursing staff, floating heels with SAGE boots (Stryker, Cary, IL) when in bed applied by nursing during admission assessment, a turning and positioning system (SAGE) for patients who weigh >200 lb and as needed, and applying Aloe Vesta barrier cream (ConvaTec, Bridgewater, NJ) to feet/skin daily. — Linda Droste, MSN, RN, CWOCN

Compression ordering protocol: Medi USA came up with a “How-To” order and size compression devices. This tear off sheet is easy to send to a receiving provider. — Cathy Milne, MSN, APRN, CWOCN-AP

Multidisciplinary teams: The only care plan that works is a multidisciplinary one. Develop a team, round with the team, and don’t forget those “hidden” team members (wife, the transporter, the housekeeping staff).  — Cathy Milne, MSN, APRN, CWOCN-AP

Patient education and engagement: Target at-risk populations, patients who have experienced hospital-acquired pressure injury, and their families. Involve wound, ostomy, continence practitioners, Quality and Safety departments, Risk Management, PFAC coordinators, C-suite professionals, and community partners. Deficits identified are educational materials that come from the patient perspective and advice on how to partner with caregivers in prevention and treatment. — Phill Botham, MSN, RN, CWON

Venous ulcer management: The care plan should include standard wound care, MIST ultrasound (Celleration Inc, Eden Prairie, MN) or ultraviolet C if indicated, multilayer compression wrap (full or modified compression depending on the vascular status and presence of peripheral arterial disease), and exercise, especially ankle exercises to activate the venous pump. Begin with ankle pumps, heel/toe raises while sitting and then standing, ankle rocker board exercises, and gait training to emphasize the heel/toe gait that facilitates gastric-soleus contraction. Professionals involved include physical therapists. Product(s) used include Smith and Nephew Profore, but any multilayer compression system that provides the ability to adjust the pressure by either reducing the layers or altering the wrapping technique. — Rose Hamm, DPT, CWS

This column was not subject to the Wound Management & Prevention peer-review process.