April New Products & Industry News

Soothing antifungal cream relieves skin discomfort

  3M Skin & Wound Care (St. Paul, MN) introduced easy-to-apply 3M Cavilon Antifungal Cream. The new cream soothes redness, irritation, scaling, itching, and burning associated with fungal infections. The cream has been enriched with water-repelling ingredients, critically important for protecting vulnerable skin and ideal for assisting caregivers in incontinence settings. The cream is formulated with 2% miconazole nitrate, an active ingredient clinically proven to treat tinea corporis (ringworm), tinea pedis (athlete’s foot), and tinea cruris (jock itch) and features a barrier property that resists washing off. The product also is approved for use on fungal infections caused by Candida albicans. In the fall 2010, the entire Cavilon brand was updated with new, innovative packaging to help caregivers easily identify the right product for a specific need. Later this year, 3M will be adding enhanced product formulations, sizes, and new patient-friendly delivery systems to the Cavilon line, reinforcing its strong commitment to skin care.   For more information, visit www.3m.com/SkinHealth.com.

Mattress overlays have stronger handwell design

  EHOB Inc (Indianapolis, IN) is introducing a stronger new handwell design on all Waffle® Mattress Overlays. The patent-pending, dog-bone shaped handwells, located around the perimeter of the product, naturally contour to the hand for an easy grip and a firm hold. With the updated design, caregivers maintain a comfortable, more secure stance while moving patients.

  For more information, visit www.ehob.com.

Compression system receives FDA clearance

  Venous Health Systems Inc (Portola Valley, CA) received 510(k) FDA clearance to market the Vasculaire™ Compression System in the US. The compression system is a portable pneumatic device for treating vascular insufficiency featuring a pneumatic controller attached to a patented multicell compression sleeve. When the compression sleeve is placed on the patient’s calf and foot and the controller is activated, the cells promote circulation with a sequential rapid inflation wavelike motion. The increase in venous velocity achieved using the system tests well within the range of values reported by the market-leading sequential pneumatic compression system. Without airlines or power cords, the system represents a long-awaited solution for the hospital, extended care facility, and home markets.

  The new system delivers performance in a palm-sized unit directly attached to the patient’s calf sleeve. Unlike other pneumatic compression devices, which can weigh up to 12 lb, this system weighs less than 1 lb, enabling patient mobility and potentially increasing patient compliance. The system also is used as a prophylactic therapy to prevent deep vein thrombosis (DVT), and may enhance blood circulation, reduce edema, diminish postoperative pain and swelling, reduce wound healing time, and help treat stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, and chronic venous insufficiency.

  For more information, contact info@venoushealth.com.

Pneumatic compression devices are patient friendly

  WayPoint Medical Supply (King of Prussia, PA) developed a full range of pneumatic compression devices for the treatment of lower-extremity lymphatic, venous, and arterial disorders. Innovations from the brain-trust of a wide-range of national DMEs with decades of experience in the daily use of pneumatic compression devices are incorporated into the company’s E0651 and E0652 pneumatic compression pumps and E0675 arterial assist devices. The devices are patient friendly and eligible for reimbursement by Medicare and most private insurance plans. The devices are designed for ease of use by the elderly and by patients with limited range of motion and feature automatic timers and inflation and deflation cycles. They are shipped directly to the patient and are supported by a company that puts patient needs first, providing rapid response to patient referrals and feedback on all patient outcomes.

  For more information, visit www.waypointmed.com.

Wound gel receives FDA 510(k) clearance

  Derma Sciences Inc (Princeton, NJ) received 510(k) clearance from the FDA for the company’s patent-pending Medihoney® Gel Wound and Burn Dressing. This latest Medihoney line extension is dispensed from a tube and is comprised of active Manuka (Leptospermum) honey blended with natural-based gelling agents. The gel will provide clinicians and patients added versatility in their use of honey-based products for challenging wounds and burns. Because the product is blended with gelling agents, the honey is able to better maintain its physical integrity at the site of the wound, even in the presence of wound fluid and body heat. This will make for a more durable and lasting product, key to chronic wound management. The company will manufacture the new gel in its Toronto facility.

  For more information, visit www.dermasciences.com.

New line of advanced wound care products introduced

  MediPurpose® (Atlanta, GA) introduced its new advanced wound care product collection, MediPlus™. The advanced wound care product line includes: foams (MediPlus™ Foam, MediPlus™ Comfort Foam, MediPlus™ HC Foam, and MediPlus™ HC Super); hydrocolloids (MediPlus™ HC [1.0 mm], MediPlus™ HC Thin [0.3 mm], and MediPlus™ HC Comfort); hydrogels (MediPlus™ BarrierGel and MediPlus™ BarrierGel Comfort); nonadherent pads (MediPlus™ PE Pad; Post-Surgical Dressings: MediPlus™ PU Pad, MediPlus™ Surgical); and thin films (MediPlus™ PU Film and MediPlus™ PU Frame).

  Along with the advantages of competitive pricing, the company enables wound care product distributors to reduce inventory levels, improve profit margins, increase market share, enhance company image through private label packaging, and access new products being sourced through the company’s new business development initiatives.

  For more information, visit www.medipurpose.com.

Three-part system protects patients and staff

  Sage Products Inc (Cary, IL) launched a new system to help protect patients in the ICU from sacral pressure ulcers and help prevent staff injuries due to turning and repositioning patients. The Prevalon® Turn and Position System has three parts: the Low-Friction Glide Sheet, which moves with the patient to make turning easier; the Microclimate Body Pad, a disposable pad that is placed under the patient to manage heat and moisture; and two 30-Degree Body Wedges to easily position patients for pressure redistribution and to offload the sacrum.   The system stays under the patient throughout the hospital stay to assist healthcare workers with turning, repositioning, and boosting, protecting patients from sacral pressure ulcers, the most common type of pressure ulcer. It also manages moisture due to incontinence and other sources, in addition to helping minimize friction and shear on the patient. Because it stays under the patient throughout the length of stay, it also helps increase staff compliance to a q20 turning protocol. Along with the system, the company is developing a new pressure ulcer prevention protocol called M2 to address mobility and moisture.

  The new system requires 71% less effort to turn a patient compared to traditional methods using a draw sheet and pillows. It decreases nursing time needed for turning, requires fewer nurses, and helps improve compliance to turning/repositioning protocols.

  For more information, visit www.sageproducts.com.

Wound debridement and cleansing solution benefits patients and providers

  IrriSept® (Innovation Technologies, Inc) is the first and only FDA-cleared wound debridement and cleansing system containing chlorhexidine gluconate (CHG). The 0.05% CHG concentration in the cleansing system has been shown effective in laboratory testing against a variety of bacteria and fungi, including staph and methicillin-resistant Staphylococcus aureus (MRSA). The solution has passed FDA-required tests for cytotoxicity, skin irritation, and immune (allergic) response.

  This system can be applied directly to surgical or deep traumatic wounds, burns, abrasions, lacerations, and SSTIs including abscesses, delayed closures, dehiscence, pilonidal cysts, or infected wounds. The system is designed for use in operating rooms, wound care centers, ERs, burn units, and other healthcare settings.

  The cleansing system is available for use in surgical and nonsurgical environments. The surgical product (IrriSept O.R.) includes a choice of three irrigation applicators: the original SplatterGuard® and the LT SplatterGuard®, designed specifically for abscess cleansing that reduce healthcare workers’ exposure to biohazard aerosolized contamination, and the IrriProbe™ for deeper wound cleansing. The nonsurgical product (IrriSept) includes the same applicators with the exception of the OR-specific IrriProbe.

  For more information, visit www.medline.com.

Bedside pressure ulcer pocket guide goes “mobile”

  The Pocket Guide to Pressure Ulcers (Princeton, NJ), authored by Elizabeth Ayello, PhD, RN, MAPWA, FAAN, and Jeffrey M. Levine, MD, AGSF, CMD, is now available as a downloadable iBook. The iBook guide provides instant access to vivid full color photos, illustrations, and descriptions downloadable to the iPad, iPod Touch, and iPhone. In addition, the guide has been updated with MDS 3.0 compliance information for long-term care professionals. The spiral-bound, laminated version is still available.

  For more information, visit www.nopressureulcers.com.

Agreement forged to market and distribute bacteriostatic dressings

  Hollister Inc (Libertyville, IL) and Hydrofera LLC (Fort Worth, TX) signed an exclusive distribution agreement that gives Hollister Wound Care LLC exclusive rights to market, sell, and distribute Hydrofera Blue Dressings, effective March 1, 2011.

  The dressings are bacteriostatic and proven effective in inhibiting the growth of micro-organisms commonly found in wounds, including MRSA and VRE. These dressings are produced through a patented process combining PVA foam with two organic pigments, methylene blue and gentian violet. The construction provides a matrix that allows the dressing to absorb wound exudate and provide broad-spectrum bacteriostatic protection.

  For more information, visit www.hydrofera.com or www.hollisterwoundcare.com.

Analysis supports efficacy and safety of wound care system

  Spiracur® Inc (Sunnyvale, CA) announced encouraging interim results from a clinical study highlighting the safety and efficacy of its SNaP® Wound Care System for the treatment of chronic lower extremity wounds. The 12-center randomized-controlled trial (RCT) was performed under the guidance of David G. Armstrong, DPM, MD, PhD; William A. Marston, MD; Alexander M. Reyzelman, DPM; and Robert S. Kirsner, MD, PhD. The study compared the device to the electrically powered Vacuum-Assisted Closure (V.A.C®) Therapy System (KCI, San Antonio, TX) in the treatment of chronic lower extremity wounds. The trial enrolled 65 patients with lower extremity wounds who were randomly assigned to treatment with either the SNaP or V.A.C Systems. The trial evaluated treatment for up to 16 weeks or until there was complete closure of the ulcer. Planned interim analysis of the first 65 patients found no significant differences in the proportion of subjects healed between the two devices evaluated or in percent wound size reduction. Non-inferiority was demonstrated between the two therapies in percent wound size reduction to the P <0.05 significance level. The study also found no significant differences in wound-related complications such as wound infections. The study’s secondary endpoints included time for dressing change and quality of life (QOL) measurements. Results for device application time showed that patients required 21 minutes to apply the V.A.C System and 9 minutes to place the SNaP System on the wound area. QOL surveys demonstrated no significant differences in reported pain, perceived effectiveness, and patient satisfaction between the devices. However, the SNaP System interfered less with overall activity, sleep, and social interaction — 92.4% of SNAP users versus 33.3% of V.A.C. System users study were able to work and perform normal daily activities while being treated with the NPWT device.

  For more information, visit www.spiracur.com.

Diabetic foot ulcers healing research published

  Sanuwave Health Inc (Alpharetta, GA) published results of research conducted in Taiwan comparing the effectiveness of the company’s dermaPACE® device with hyperbaric oxygen therapy (HBOT) in treating chronic diabetic foot ulcers. This prospective, open-label, randomized study included patients with chronic, nonhealing diabetic foot ulcers of at least 3-months’ duration with infection, localized pus, bone inflammation, and (some) gangrene that were predominately grade III and IV on the Wagner Ulcer Classification Scale. The study included notably sick patients who, absent successful medical treatment, may have been faced with surgical intervention, including limb amputation.

  The device demonstrated significantly improved healing compared with HBOT (P = 0.003) — after one course of treatment, the device completely healed 24 ulcers compared with 10 ulcers that healed as a result of HBOT (2.4 times more). Following a second course of treatment, the device completely healed a combined 31 ulcers in comparison with 11 ulcers for HBOT (2.8 times more). After one course of treatment, a significantly greater number of ulcers treated with HBOT were unchanged in size and depth compared with ulcers treated with the device (P <0.001). Perfusion (blood flow) significantly increased in the device group after treatment (P <0.001), while remaining statistically unchanged in the HBOT group. Additionally, device users required 85% fewer treatments and 97% less treatment time compared with HBOT.

  For more information, visit www.sanuwave.com.

Therapeutics company and medical center study diabetic foot ulcers

  Pluristem Therapeutics Inc (Aifa, Israel) and New York University (NYU) Medical Center (New York, NY) formed a partnership to study the use of Pluristem’s proprietary placenta-derived PLX cells for the treatment of diabetic foot ulcers (DFU). Weiliam Chen, RPh, PhD, Director of the Tissue Engineering Research Laboratory, Department of Surgery at NYU’s Helen L. and Martin S. Kimmel Wound Healing Center, will be the principal investigator of these preclinical studies, which are the first step toward a future potential Phase II clinical study for treatment of DFU.

  An in vitro model and a series of animal models will be used to evaluate the role PLX cells have in healing DFU. Through an academic industrial collaborative research paradigm, these trials, with proposed support from the National Institutes of Health (NIH), will be used as a bridge toward the potential treatment of patients with diabetic foot ulcers. This partnership is important to developing an advanced cellular — PLX cells can stimulate angiogenesis, which is highly advantageous in treating diabetic chronic wounds. The PLX cells also can directly address cellular impairment in diabetic wounds leading to tissue regeneration in the wound beds.

  For more information, visit www.pluristem.com.

Diabetic wound care specialty accredited

  The National Alliance of Wound Care (NAWC®, Glendale, WI) awarded the first diabetic wound certified (DWC®) credential to a group of wound care candidates who successfully passed the DWC certification examination. The DWC is the first advanced wound care certification in the specialty of diabetic wounds. The forward- thinking NAWC now affords thousands of clinicians certified in wound care the opportunity to obtain an advanced certification in diabetic wounds. The NAWC estimates nearly 800 candidates will receive their (DWC) board certification in 2011. The DWC credential demonstrates a wound care professional’s proficiency and mastery of essential knowledge and skills of diabetic wound management above basic wound care certification. The DWC is available to all wound care professionals who are currently wound care certified through a nationally accredited program.

  For more information, visit www.nawccb.org.

This article was not subject to the Ostomy Wound Management peer-review process.