Top 10 News Items of '09

Derma Sciences, Inc. (Princeton, NJ), a specialty medical device/pharmaceutical company specializing in advanced wound care, recently announced that the US Food and Drug Administration (FDA) has issued its Guidance Document to support the classification of the company's BIOGUARD™ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's de novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device. The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med US patents/patents pending and in 24 foreign counterparts.  

Visit www.dermasciences.com for more information.

Leading medical journal, Podiatry Today, published its annual list of “Top Innovations in Podiatric Care” in the August 2009 issue. Listed at number 5 on the top 10 list is TheraGauze™, the wound dressing manufactured by Soluble Systems LLC (Newport, Va). The article highlights the company’s proprietary Skin Moisture Rebalancing Technology (SMRT), which enables the dressing to “read” a wound and donate or absorb moisture as needed to enhance healing outcomes of difficult chronic wounds. The dressing is a sterile proprietary polymer dressing that regulates moisture differentially across the wound site. When used as directed, the dressing remains moist and active for up to 7 days— reducing the frequency of dressing changes. The SMRT dressing will not macerate tissue or stick to the wound, and leaves no residue. The dressing has received the prestigious “Seal of Approval” from the American Podiatric Medical Association, and is clinically proven to surpass even growth factor treatment for the closure of diabetic foot ulcers.

Visit www.solublesystems.com for more information.

Prospera Technologies (Fort Worth, Tex) announced that Swedish researchers directly compared the use of high- and low-pressures for negative pressure wound therapy (NPWT) in a pig model. Clinicians are pointing out the biological benefits of lower, intermittent, and variable pressures such as reduced patient pain and increased granulation tissue formation. For example, Christian Torbrand, MD of Lund University (Sweden) presented “Biological Effects of Negative Pressure Wound Therapy at Low Levels of Negative Pressure—Intermittent and Variable Negative Pressure Wound Therapy.” The study represents several firsts in NPWT research: the effects of lower negative pressure on regional blood flow, wound contraction, and fluid removal. Biological effects in response to intermittent and variable pressure were delineated for the first time in detail. Using laser Doppler in a pig wound model, Torbrand and colleagues examined effects at pressures ranging from as low as -10 mm Hg to -175 mm Hg. In variable NPWT, two alternating pressure levels are used, but negative pressure is always maintained without a drop to 0 mm Hg. The study showed blood flow changed gradually with increasing levels of negative pressure, reaching 100% of maximum effect at approximately -75 mm Hg. These study results challenge the conventional way of thinking about NPWT and the use of higher negative pressures.

Visit www.prospera-npwt.com for more information.

Uluru Inc (Addison, Tex) announced the presentation of results from the first completed randomized clinical trial for Altrazeal™ Transforming Powder Dressing at the Symposium on Advanced Wound Care (SAWC) Fall Symposium, which took place in Washington D.C., September 16–18, 2009. The dressing is a revolutionary wound treatment technology that utilizes proprietary Nanoflex™ technology to promote the healing of exuding wounds. The recently completed clinical study compared healing, pain, and comfort of skin graft donor sites treated with either the dressing or with a leading commercial sodium carboxymethylcellulose-silver (CMC-Ag) dressing. Major results from the study indicated that there was a significant difference in patient’s pain scores, all favoring the dressing with lower pain scores at each time point (P < 0.001). When asked about the comfort of the wound dressing at the edges, these subjects found the dressing to be more comfortable (P < 0.001) and less painful when the dressing came in contact with clothes or bedding (P < 0.001). The study endpoints validated the hypothesis for time to healing for both dressings in this particular type of acute surgical wound.

The study was a single center, prospective, randomized trial in which each patient served as his or her own control. Each patient had at least two split-thickness donor sites of which one was dressed with the dressing and the other with the CMC-Ag dressing. In addition to the randomized clinical trial, more clinical evidence on the treatment of various wound types using the transforming powder dressing were presented on multiple posters during the symposium.

Visit www.uluruinc.com for more information.

Kinetic Concepts Inc [San Antonio, Tex] has officially launched the ABThera™ open abdomen negative pressure therapy system, the latest addition to its Negative Pressure Technology Platform (NPTP). The company estimates there are approximately 250,000 open abdomen procedures performed annually within the United States and European Union. ABThera addresses patient quality of life through a convenient system designed to assist surgeons in the management and treatment of the “open abdomen” and to help achieve primary fascial closure. The benefits of the new system include active removal of fluid and reduction of edema, providing medial tension that helps minimize fascial retraction and loss of domain, assistance in isolating viscera and abdominal compartment from external environment, separation between the abdominal wall and viscera, and removal of infectious and inflammatory materials from the abdomen. The system can be used adjunctively with other KCI products. In most serious cases, surgeons can use the LifeCell Strattice™ Reconstructive Tissue Matrix or AlloDerm® Regenerative Tissue Matrix, products from the company’s regenerative medicine division, as a bridging material to help achieve wound closure following the application of ABThera.

Visit www.kci1.com for more information.

Smith & Nephew Inc’s Advanced Wound Management division recently announced the US launch of Acticoat™ Flex 3 and Acticoat™ Flex 7, in efforts to expand the Acticoat portfolio. Acticoat Flex products have been designed to support physicians dealing with wounds and injuries at high risk of infection. Utilizing the Silcryst® nanocrystalline silver technology of Acticoat, the Flex line provides enhanced conformability on awkward anatomical areas, such as the face and hands, and breakthrough stretch properties to improve patient comfort during wear. The Flex wound care products were recently cleared for market use by the US Food and Drug Administration and were cleared for use by Health Canada in late 2008. Combining the flexibility of the polyester mesh substrate with the proven effectiveness of Acticoat’s nanocrystalline silver technology is a significant development for the brand. The flex dressing line was a result of the suggestions of healthcare providers and understanding their needs when dealing with wounds in hard to dress areas.

Visit www.smith-nephew.com for more information.

SIGVARIS (Peachtree City, GA) launched the UlceRx Therapy Solution Kit, a medically effective compression stocking kit for the treatment of venous leg ulcers. The kit consists of two underliner stockings and two 30 mmHg–40 mmHg graduated medical compression stockings. One of the pain reducing factors of the new kit is the underliner stocking that is made from 100% cotton to soothe the wearer’s skin. The outer layer fabric also provides a “glide,” which enables the outer stocking to be put on more easily, reducing the pain and discomfort of applying compression to a wound.

In a recent study, 96.2% of the participating patients achieved complete closure of their wound with the use of the stocking kit (there is only a 70% complete wound closure rate with traditional bandages) and healed ulcers up to 4 cm in diameter twice as fast compared to bandage wrapping. Patients using the stocking kit reported that pain was absent during both the morning and night with the use of the kit, whereas patients using bandages experienced markedly stronger pain when bandages were applied and removed.

Visit www.sigvaris.com for more information.

Soluble Systems recently launched TheraGauze+FN™, the latest product in their line of moisture regulating wound dressings. TheraGauze+FN utilizes the same SMRT polymer technology found in TheraGauze™ but is fenestrated to treat moderate to heavily exudating wounds. TheraGauze is a sterile proprietary polymer wound care dressing that regulates moisture differentially across the wound site. The new dressing is fenestrated (+FN) to allow excess exudate to pass through the dressing into a secondary absorbent dressing. The dressing can be used with negative pressure wound therapy (NPWT) as the wound interface for precise moisture regulation and non-adherence. When used as directed, TheraGauze and TheraGauze+FN remain moist and active for up to 7 days, reducing the frequency of dressing changes. TheraGauze has received the prestigious “Seal of Approval” from the American Podiatric Medical Association, and is clinically proven to surpass even growth factor treatment for the closure of diabetic foot ulcers.      

Visit www.solublesystems.com for more information.

ConvaTec’s (Skillman, NJ) new Engenex® Advanced Negative Pressure Wound Therapy (NPWT) System was designed specifically for the application of negative pressure of wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids, and infectious materials.      

The new system features Bio-Dome™ Technology and has five distinct components: a wound interface (Bio-Dome™ Standard and Bio-Dome™ EasyRelease Dressings); a transparent film cover dressing (Engenex® Cover Dressing); a tube that connects the NPWT therapy unit to the wound (Opti-Flow™ Tube Attachment Device); a collection canister (Engenex® Collection Canister); and a therapy unit to deliver intermittent or continuous NPWT (Engenex® WoundFlo® NPWT Therapy Unit). The system offers ease of use and can help clinicians provide positive clinical and economic outcomes for a variety of acute and chronic wounds across the continuum of care.      

Visit www.convatec.com for more information.

Covidien (Mansfield, Mass) recently launched the new Kendall™ AMD Antimicrobial Foam Dressings. The polyurethane dressings, impregnated with 0.5% polyhexamethylene biguanide (PHMB), are designed to promote a balanced environment by simultaneously managing moisture and bacteria. The dressings limit cross-contamination, have no known resistance, and are highly effective against common bacteria, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.      

Visit www.kendallamdfoam.com for more information.