Gauze-based NPWT Achieves Same Treatment Goals as Foam-based NPWT

     The Advanced Wound Management Division of Smith & Nephew Inc, a subsidiary of Smith & Nephew Plc (St. Petersburg, FL) highlighted the results of a multi-center study that demonstrated that gauze-based negative pressure wound therapy (NPWT) achieves many of the common treatment goals defined for foam-based NPWT systems. These goals include a reduction in wound dimension, exudate, and improvement in granulation tissue. The results of this study were presented in a poster session at the 24th Annual Clinical Symposium on Advances in Skin and Wound Care in San Antonio, Texas.

     The prospective, multi-center clinical evaluation assessed 131 non-grafted patients at 21 centers throughout the United States, Canada, United Kingdom, Saudi Arabia, and the United Arab Emirates. The results showed that wound dimensions were all significantly reduced during gauze-based NPWT (P < 0.001). A weekly percentage reduction in wound area, depth, and volume of 8.3%, 15.8%, and 20.5%, respectively, was observed. There was also a significant reduction (P < 0.001) in wound exudate levels from baseline to treatment discontinuation. A significant increase (P = 0.007) in the percentage area of the wound bed composed of red granulation tissue over the course of gauze-based NPWT was observed. Clinicians in this study found the gauze-based negative pressure system capable of application to a wide variety of wounds that due to their location, extent and level of exudate, would be difficult to manage with foam dressings. The gauze filler used in this evaluation also demonstrated some positive advantages regarding its conformability and ease of application to large and irregular wounds.

     Visit www.myrenasys.com/clinical-evidence or www.smith-nephew.com for more information.

FDA Issues Guidance for Derma Sciences’ Exclusive Wound Dressing With pDADMAC

     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. www.dermasciences.com for more information.