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News Products and Industry News September
Incision management system available to US hospitals
Kinetic Concepts Inc ([KCI] San Antonio, TX) announced the US launch of the Prevena™ Incision Management System, the latest addition to KCI’s negative pressure technology platform. The new system leverages the clinically proven effectiveness of negative pressure wound therapy that the company pioneered with the V.A.C.® Therapy System, which has been used to treat millions of complex open wounds since its introduction. The system is designed for linear incisions associated with general surgery, OB/GYN, orthopedic, and cardiothoracic incisions. Indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure, the system removes exudate and potentially infectious material; protects the surgical site from external contamination; provides a clean, protected postoperative wound environment; and helps draw incision edges together. Portable and discreet, the system is designed for single-patient use and is applied as the last step of the surgical procedure. It may accompany the patient during transition from the hospital to the home. For more information, visit www.kci1.com.
Dressing reduces risk of surgical site infection and skin blistering
ConvaTec (Skillman, NJ) launched Aquacel® Ag Surgical cover dressings, which are now available in the US for the postoperative care of surgical incisions.
Featuring the ConvaTec patented Hydrofiber® Technology combined with skin-friendly hydrocolloid technology, the surgical cover dressings have been shown to provide significant reduction in the incidence of superficial surgical site infection (SSI), skin blistering, and delayed discharge as compared to a nonwoven post-operative surgical cover dressing regimen. The cover dressing provides a waterproof, viral, and bacterial barrier that allows for flexibility and extensibility during body movement. In a prospective study involving 428 patients undergoing hip or knee surgery, a hospital’s then standard nonwoven postoperative dressing regimen (Mepore™ dressing covering Aquacel® dressing) was compared with a new dressing regimen of the dressing covered with DuoDERM® Extra Thin dressing (the main components of Aquacel® Surgical cover dressing) after application of a liquid film-forming acrylate. The new dressing regimen demonstrated a 67% reduction in superficial surgical site infection (P <0.03), an 88%reduction in blistering of (P <0.001), and an 80% reduction in delayed discharge (P <0.02).
For more information, visit www.convatec.com.
British-developed gel accelerates healing rate of chronic ulcers
British scientists and CoDa Therapeutics are developing Nexagon, a gel with the potential to increase the speed of healing among chronic ulcers by up to five times. The gel works by interrupting the way cells communicate and prevents the production of a protein, which blocks healing. So far it has only been tested on 100 patients with favorable results; if it proves an overall success it could improve the treatment of patients with diabetes who often suffer from painful and seemingly untreatable ulcers. A team of scientists at University College London, led by Professor David Becker, worked on the clear, toothpaste-like gel, which has helped treat persons with ulcers as well as a 25-year-old workman in New Zealand who accidentally got cement in his eye. With gel use, the outer lining of the man’s eye and the blood vessels within it re-grew, saving his vision. In an early study on leg ulcers, scientists found that after 4 weeks, the number of people with completely healed ulcers was five times higher in patients who were treated with the gel compared to those who were not treated with the gel. The researchers are excited that experts are beginning to support gel use.
For more information, visit www.dailymail.co.uk/sciencetech/article-1302699/British-developed-gel-speeds-healing-chronic-ulcers.html#ixzz0xSlItSgG.
Randomized, double-blind DFU study initiated
Healthpoint (Fort Worth, TX) initiated a clinical trial to evaluate daily use of Santyl® Ointment for the first 4 weeks of therapy for its ability to initiate a healing cascade by determining the wound closure rate at 12 weeks after the start of treatment. The randomized, double-blind, parallel group, placebo-controlled trial involves 100 patients who have an uninfected DFU that has failed to significantly improve after wound treatment for at least 4 weeks (less than or equal to 40% closure). Upon enrollment, subjects will be randomized to receive 4 weeks of treatment with either the ointment or petrolatum (vehicle). During both the 4 weeks of the ointment and the 8 weeks of follow-up, the target ulcers will be covered with a nonadhesive contact layer and a foam dressing. One of the long-term complications of diabetes is the development of foot ulcers primarily as a consequence of peripheral neuropathy due to prolonged serum glucose elevation. This study will help inform the clinical community as to whether a widely prescribed enzymatic debriding agent can have a positive impact on wound closure, thereby avoiding the often devastating sequelae associated with this common condition.
The study design combines two concepts: 1) wound healing can be predicted on the basis of wound area reduction during the first 4 weeks of any therapy and 2) 4 weeks of the ointment will be sufficient to promote healing during a full 12 weeks of moist wound therapy.
For more information, visit www.healthpoint.com.
Wound monitor receives licensed funding and support
Patients with diabetes-associated wounds could receive faster and more effective treatment thanks to a noninvasive device that monitors wound healing and is one step closer to market. Emunamedica LLC, a Florida-based healthcare start-up, has licensed technology for a near-infrared wound monitor from Drexel University (Philadelphia, PA). Dr. Elisabeth Papazoglou and Dr. Leonid Zubkov of Drexel’s School of Biomedical Engineering, Science and Health Systems developed the device in collaboration with Dr. Michael S. Weingarten, MD of Drexel College of Medicine and their teams. The device received joint support from the University City Science Center’s QED Proof-of-Concept Program and from the Wallace H. Coulter Translational Research Program at Drexel University. It is the first technology supported by QED Program funding to be licensed.
There are currently no accepted methods for monitoring chronic wound response to treatment beyond simply measuring the size of the wound. Surface wound area is a poor indicator of the health of underlying damaged tissues. Many people with diabetes and chronic wounds lose their limbs to amputation because of the lack of current methods to rationally assess whether treatments are working. Papazoglou and her team have developed a breakthrough device that uses near-infrared (NIR) light to measure the blood supply within and under a wound, indicating its health and rate of healing. The device is portable and can take measurements in a matter of seconds by simply passing the scanner over the wound surface, making it ideal for rapid patient assessment in a busy clinical setting. It is expected to improve the ability to identify nonhealing wounds at least 50% earlier than current methods, allowing physicians to tailor their treatments and save more limbs from amputation.
Dr. Papazoglou’s project was selected to receive a $200,000 award through the Science Center’s QED Program in its inaugural cycle in the fall of 2009. The QED Program is the first multi-institutional proof-of-concept program for life sciences technologies. It bridges the “valley of death” – the gap between academic research and commercial development by providing scientists with guidance from experienced regional entrepreneurs, feedback from regional investors, and funding to demonstrate proof of concept. Since its launch in April 2009, the QED Program has screened more than 130 proposals, provided advisory services to 20 projects, and made six awards to scientists at Drexel University, the University of Pennsylvania, Rutgers University, and Children’s Hospital of Philadelphia. It is expected to make awards to three more technologies later this year. Emunamedica expects to launch its initial product commercially in the US by the first half of 2012, bringing wound diagnostics to clinicians and the estimated 6 million-plus patients in the US who suffer from lower extremity ulcers.
For more information, visit www.drexel.edu.
Privately held company acquired for $150 million
Stryker Corporation (Kalamazoo, MI) announced a definitive agreement to acquire privately held Gaymar Industries (Orchard Park, NY) for approximately $150 million in an all-cash transaction. Gaymar specializes in support surface and pressure ulcer management solutions as well as the temperature management segment of the healthcare industry, with an attractive portfolio of capital and disposable products in both the US and international markets. The transaction, which is expected to close by October 1, 2010, is conditioned on expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period and other customary closing conditions. The boards of directors of both Stryker and Gaymar Industries have approved the transaction.
The acquisition expands Stryker’s product offerings in the high-performance support surface and pressure ulcer management market, while also providing a complementary product offering to its existing customer base through its temperature management technology platform. Following the global economic contraction in late 2008 and early 2009, which adversely impacted hospital spending, Gaymar refocused its management and business strategy and has since demonstrated an impressive recovery consistent with its history as a growing specialty products company. Gaymar achieved sales of approximately $77 million in 2009, of which approximately $14 million were related to the existing OEM relationship with Stryker.
For more information, call (646) 747-7163.
Contract initiated with shared services organization
Innovative Therapies Inc ([ITI] Gaithersburg, MD) recently signed a negative pressure wound therapy (NPWT) contract with the Mid-Atlantic Group Network of Shared Services (MAGNET), encompassing both rental and sales of ITI’s proprietary NPWT technology. MAGNET chooses its providers based on their ability to deliver proven, innovative technology to a cost-aware healthcare industry. MAGNET is one of the nation’s largest and most experienced shared services organizations. This contract introduces ITI to MAGNET’s approximately 9,500 providers including hospitals, alternate care facilities, physician practices, and clinics in Northeastern, mid-Atlantic, and Midwestern states. Working with MAGNET’s sales force, ITI will expand its profile as a leader in the field.
For more information, visit www.itinpwt.com.
This article was not subject to the Ostomy Wound Management peer-review process.