Industry News May 2010

Net Health Partners with KCI to Provide V.A.C.^® Therapy Integration

  Net Health Systems Inc (Pittsburgh, PA) announced the release of new functionality in the WoundExpert software enabling physicians to pre-populate V.A.C.^® Therapy authorization forms, electronically sign, and transmit by means of a secure link directly to Kinetic Concepts Inc ([KCI] San Antonio, Tex). The inclusion of this functionality is another step forward in Net Health’s continuing to provide new efficiencies, improve ease of use, and reduce errors in wound care. The inclusion of V.A.C. Therapy ordering through WoundExpert provides: • Seamless creation of the KCI V.A.C. Therapy Order Form, pre-populated with WoundExpert data • Automatic Error checking for form compliance • Inclusion of electronic signatures on the KCI V.A.C. Therapy Order Form • Direct transmission for approval from WoundExpert to KCI • Integration with WoundExpert’s electronic documentation The introduction of V.A.C Therapy order functionality within WoundExpert will become available in May 2010.   Visit www.woundexpert.com or www.KCI1.com for more information.

Sanuwave Completes Enrollment in dermaPACE Phase III Pivotal IDE Clinical Trial

  Sanuwave Health Inc (Alpharetta, GA) announced that patient enrollment was completed in March 2010 in its dermaPACE^™ Phase III pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression (PACE ^™ ) technology, utilizing the dermaPACE^™ tissue regeneration device, to sham control for the treatment of diabetic foot ulcers (DFU).   The primary study goal is to establish superiority in DFU healing rates using the treatment compared to sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings, which is the most widely used primary dressing material in the United States, and offloading with a walking boot. A total of 207 patients have entered the study at 24 sites, including Boston Medical   Center, Phoenix VA, Northwestern University in Chicago, VA Long Beach, California, The Ohio State University Medical Center in Columbus, King's College Hospital in London, Emory Orthopedics and Spine Center in Atlanta, Calvary Hospital in New York, and the North American Center for Limb Preservation in New Haven, Connecticut. The principal investigators in the study represent the multidisciplinary nature of treating chronic wounds, including specialties such as vascular surgery, plastic surgery, podiatry, and endocrinology. The study patients must be followed a total of 24 weeks. The study's primary endpoint— wound closure— is defined as "successful" if the skin is re-epithelialized without drainage or dressing requirements confirmed at two consecutive study visits.   Final study data including time to closure, total wound size reduction, long-term safety, and study subject assessments is expected to be available by the fourth quarter of this year. The Company plans to announce a summary of the top-line data immediately following validation of study results and statistical analysis. In addition, the Company is finalizing its regulatory submission plan with the Food and Drug Administration and will provide further information when the plan is established.   Visit www.sanuwave.com for more information.

New In-Vitro Study Data Show Importance of Dressing Conformability to Action of Silver-containing Wound Dressing

  ConvaTec (Skillman, NJ) recently announced new in-vitro study results in which a Hydrofiber^® dressing containing ionic silver was observed to conform more closely to a porcine tissue surface in a shallow wound model than did certain silver-containing foam dressings following hydration. In the in vitro study the Hydrofiber dressing containing ionic silver killed more bacteria (Pseudomonas aeruginosa and Staphylococcus aureus) beneath the dressing than any of the tested silver-containing foam dressings. In addition, the Hydrofiber dressing containing ionic silver was observed to not allow the spread of bacteria beyond the edge of the simulated wound. These data were presented at the 23rd Annual Symposium on Advanced Wound Care ([SAWC] April 17–19, 2010) in Orlando, Florida. Chronic wounds are often made up of many types of bacteria from external sources such as the surrounding skin, gut, and mouth. A wound that will not heal is an excellent environment for bacteria to colonize. Colonizing bacteria can often lead to difficult-to-treat infections. It is important that a wound dressing conforms well to the wound’s unique topography to ensure that an antimicrobial agent comes into the most contact with the threatening bacteria.   In the in-vitro study models were utilized that enabled both visualization of the conformability of silver-containing dressings with a simulated wound tissue and measurement of the antimicrobial activity of the dressings in a simulated shallow wound microbial model. The percentage of growth for each bacterium was measured for the dressing containing ionic silver and these silver-containing foam dressings (Foam A-C). Mean results of the three replicated tests measured by growth beneath the dressing were as follows: the Hydrofiber dressing containing ionic silver had 0.4% growth when inoculated with S sureus and 9.0% with P aeruginosa; Foam A had 25.7% growth when inoculated with S aureus and 97.8% with; S aureus and Foam C had 24.6% growth when inoculated with S aureus and 95.8% withS aureus .   Visit www.convatec.com for more information.

HemCon Signs Licensing Agreement With Zeria Pharmaceuticals

  HemCon Medical Technologies ([HemCon] Portland, OR) recently signed an exclusive licensing agreement with Zeria Pharmaceuticals (Tokyo). As per the agreement, Zeria is expected to market, distribute, and sell HemCon’s line of wound and oral care dressings throughout Japan. Zeria's portfolio includes hemostatic surgical compounds, which the HemCon products will augment. Zeria also operates in the gastroenterology field and markets products in dermatology and cardiovascular disease. The company also markets a range of consumer healthcare products and medications. HemCon’s product offerings include a full line of hemostatic dressings with antibacterial properties. The technology, originally developed for use on the battlefield to control severe hemorrhaging, is used in acute care settings worldwide for bleeding control, wound management, and infection prevention. HemCon’s line also includes an OTC line of hemostatic products and oral wound care dressing for oral surgery and periodontal procedures. Zeria’s partnership with HemCon will allow them to strategically expand their product offering and market reach in the wound care, surgery, oral care, and patient safety markets.   Visit www.hemcom.com for more information.

Prospera^®Educational Symposium Redefines Best Practices in NPWT

  Prospera Technologies LLC (Fort Worth, TX) hosted a major negative pressure wound therapy (NPWT) scientific symposium on April 17, 2010 during the Symposium on Advanced Wound Care ([SAWC] April 17-19, 2010) in Orlando, Florida. The unusually comprehensive session titled, “The Evolution of NPWT: Evidence-based Innovations to Optimize Therapy and Avoid Complications,” featured keynote speaker Malin Malmsjö, MD, PhD, Associate Professor at Lund University, Lund, Sweden. The meeting not only addressed key NPWT variables in light of recent scientific evidence, but also offered practical guidance to the 150 wound care professionals in attendance (physicians, nurses, therapists, and others). Historical gaps in the NPWT evidence base were outlined, followed by a step-by-step review of recent novel studies testing the use of various negative pressure levels, various wound fillers, and different modes of negative pressure delivery (continuous, intermittent, and variable). Claus Brandigi, MD, Associate Director, Joseph M. Still Burn Center (Augusta, GA), moderated the session. In her opening remarks, speaker Cindy Ahearn, RN, MS, ET, CWCN, FNP-BC, Director of Clinical Services for Prospera, stated that for many years, there was an unwavering acceptance of a ‘gold standard’ that involved using continuous negative pressure at -125 mmHg, and a foam filler. Despite incomplete evidence and knowledge about the actual biological effects of various NPWT practices, and despite frequent pain and the need for considerable pain medication, few people questioned this predominate protocol. Things began to change just a few years ago, when studies conducted in a number of countries began to be presented and published.   Malmsjö then presented (via digital download and teleconference), results of a comprehensive series of studies in porcine wound models that she and her colleagues had conducted. She was unable to attend the symposium in person because of the volcano eruption in Iceland and the subsequent airline disruptions. The studies she presented covered microvascular blood flow using various negative pressures and wound fillers, tissue in-growth, force required to remove foam versus gauze, pressure transduction, macro and microdeformation (mechanical effects of NPWT), granulation tissue characteristics, wound bed histology, and measurement of neuropeptides as signals of pain during dressing changes. The Swedish team also found that foam filler is subject to tissue ingrowth, whereas gauze is not, and that much more force is required to remove foam than gauze. Granulation tissue formed using foam is thick, disorganized, and less stable than granulation tissue formed using gauze, which is thinner and more stable, and less prone to scarring. Leukocytes are found in greater amounts in wound bed tissues using foam versus gauze. In the most recent study, the team measured calcitonin gene related peptide (CGRP) and substance P, neuropeptides known to be released upon tissue trauma and inflammation that may signal pain. The foam and gauze fillers were removed following 72 hours of NPWT. Both CGRP and substance P were significantly more abundant after removal of foam than gauze.   Visit www.prospera-npwt.com for more information.

Solutions^® Algorithms From ConvaTec Re-Accepted by US National Guideline Clearinghouse

  ConvaTec (Skillman, NJ) announced that its Solutions^®Algorithms for Wound Care, an evidence-based wound assessment and treatment guideline has been re-accepted by the US National Guideline Clearinghouse (NGC). The algorithms were first accepted by the NGC in 2006 and remains the only comprehensive set of content-validated wound care algorithms on the site. In the renewal process required by NGC every 3-5 years, the company performed a systematic literature search, finding no changes to the algorithms were necessary. Launched by the company more than 10 years ago, the product has been content-validated by both US and international wound experts. When combined with a ConvaTec product formulary and used within a protocol of care, the algorithms have been proven in multiple studies published in peer-reviewed journals to improve clinical and economic outcomes in a variety of healthcare settings for both acute and chronic wounds. According to Janice Beitz, PhD, RN, CS, CNOR, CWOCN, CRNP and Lia van Rijswijk, RN, MSN, CWCN from La Salle University’s School of Nursing and Health Sciences who recently completed a study to assess if the Solutions^® Algorithms helped registered nurses provide optimal care, algorithms, concept maps, and decision trees are designed to help healthcare professionals' decision-making. Because they can greatly affect the quality of patient care, it is imperative that their content and usage are research-based. Solutions^®Algorithms for Wound Care can be accessed on the NGC database at www.guideline.gov.   Visit www.convatec.com or call 800-422-8811 for more information.

Prospera^®Educational Symposium Redefines Best Practices in NPWT

Prospera Technologies LLC (Fort Worth, TX) hosted a major negative pressure wound therapy (NPWT) scientific symposium on April 17, 2010 during the Symposium on Advanced Wound Care ([SAWC] April 17-19, 2010) in Orlando, Florida. The unusually comprehensive session titled, “The Evolution of NPWT: Evidence-based Innovations to Optimize Therapy and Avoid Complications,” featured keynote speaker Malin Malmsjö, MD, PhD, Associate Professor at Lund University, Lund, Sweden. The meeting not only addressed key NPWT variables in light of recent scientific evidence, but also offered extremely practical guidance to the 150 wound care professionals in attendance (physicians, nurses, therapists, and others). Historical gaps in the NPWT evidence base were outlined, followed by a step-by-step review of recent novel studies testing the use of various negative pressure levels, various wound fillers, and different modes of negative pressure delivery (continuous, intermittent, and variable). Claus Brandigi, MD, Associate Director, Joseph M. Still Burn Center (Augusta, GA), moderated the session. Speaker Cindy Ahearn, RN, MS, ET, CWCN, FNP-BC, Director of Clinical Services for Prospera, in her opening remarks, stated that for many years, there was an unwavering acceptance of a ‘gold standard’ that involved using continuous negative pressure at -125 mmHg, and a foam filler. Despite incomplete evidence and knowledge about the actual biological effects of various NPWT practices, and despite frequent pain and the need for considerable pain medication, few people questioned this predominate protocol. Things began to change just a few years ago, when studies conducted in a number of countries began to be presented and published. Malmsjö then presented (via digital download and teleconference), results of a comprehensive series of studies in porcine wound models that she and her colleagues had conducted. She was unable to attend the symposium in person because of the volcano eruption in Iceland and the subsequent airline disruptions. The studies she presented covered microvascular blood flow using various negative pressures and wound fillers, tissue in-growth, force required to remove foam versus gauze, pressure transduction, macro and microdeformation (mechanical effects of NPWT), granulation tissue characteristics, wound bed histology, and measurement of neuropeptides as signals of pain during dressing changes. The Swedish team also found that foam filler is subject to tissue ingrowth, whereas gauze is not, and that much more force is required to remove foam than gauze. Granulation tissue formed using foam is thick, disorganized, and less stable than granulation tissue formed using gauze, which is thinner and more stable, and less prone to scarring. Leukocytes are found in greater amounts in wound bed tissues using foam versus gauze. In the most recent study, the team measured calcitonin gene related peptide (CGRP) and substance P, neuropeptides known to be released upon tissue trauma and inflammation that may signal pain. The foam and gauze fillers were removed following 72 hours of NPWT. Both CGRP and substance P were significantly more abundant after removal of foam than gauze.   Visit www.prospera-npwt.com for more information.