Healthcare Industry News: Bristol-Myers Squibb
News Release - May 14, 2008
ConvaTec Introduces VERSIVA(R) XC(TM) Gelling Foam Dressings to U.S.Adhesive and Non-Adhesive Versions Now Available for Wound Management
SKILLMAN, N.J.--(HSMN NewsFeed)--ConvaTec, a world-leading manufacturer of ostomy and wound care products, today announced the availability of Versiva® XC™ Gelling Foam Dressings with Hydrofiber® Technology, in both Adhesive and Non-Adhesive formulations, for use by health care professionals who treat acute and chronic wounds.
“We are very pleased to introduce Versiva® XC™ Gelling Foam Dressings, and anticipate that these products will redefine wound management and patient care in the U.S.,” said Nino Pionati, Senior Vice President of Global Marketing and Business Development, ConvaTec U.S. Wound Therapeutics. “In addition to protecting periwound skin and supporting healing, Versiva® XC™ Gelling Foam Dressings also cushion and protect, thereby increasing patient comfort at the time of dressing removal.”
Two recently published Phase II studies demonstrated the safety and performance of Versiva® XC™ Gelling Foam Dressings as part of a protocol of care in promoting wound healing by managing exudate, protecting the surrounding skin and minimizing patient discomfort.1,2
Managing exudate, the plasma-like fluid that leaks in varying quantities from wounds,3 can be challenging for clinicians, as outlined in a 2007 World Union of Wound Healing Societies consensus document.3 While an excess can be harmful or delay healing, exudate is also known to assist healing.3 Based on the principles of moist wound healing, Versiva® XC™ Gelling Foam Dressings were developed to provide an optimal level of moisture absorption and fluid retention to help clinicians more effectively manage moderate to heavy wound exudate. In vitro testing of Versiva® XC™ Gelling Foam Dressings compared to traditional foam dressings demonstrated its superior retention capability, with more than 90 percent of fluid retained within the dressings under a 40 mm Hg load (p<0.05).4
Leg Ulcer Management
In the first prospective, non-comparative, multi-center study, the safety and performance of Versiva® XC™ Non-Adhesive Gelling Foam Dressing as part of a protocol of care was evaluated over four weeks in 46 patients* who had moderately to heavily exuding leg ulcers.1 At final evaluation, 89 percent of clinicians reported that their patients’ leg ulcers had healed or improved,1 and a 50 percent decrease in mean wound size was noted from baseline to final evaluation (10.1 cm2 to 5.1 cm2).1 Dressings were changed at least every seven days, or until the ulcer healed.1 Average wear time was 3.2 days,1 although the dressings can be left in place for up to 7 days, and 99 percent of dressing changes were for reasons other than leakage.1 Clinicians rating the dressings as “excellent” for ease of application and removal were 89 percent and 96 percent, respectively.1 Additionally, investigators rated the dressing’s ability to soothe wounds as “excellent” or “good” for 93 percent of patients.1
Pressure Ulcer Management
The safety and effectiveness of Versiva® XC™ Adhesive Gelling Foam Dressing as part of a protocol of care also was evaluated in a similar Phase II study of 23 patients with exuding pressure ulcers.2 All were stage II to IV pressure ulcers,2 with mean duration prior to enrollment of one year.2 After four weeks, healing or subjective improvement of the ulcer was reported in 61 percent of patients, and mean reduction in ulcer area was 13 percent.2 Dressings were changed at least once every seven days.2 Clinicians rated dressing wear time and avoidance of leakage as “excellent” or “good” for 61 percent and 69 percent of patients, respectively.2 Patients found the dressing to be comfortable, cushioning and soothing in situ at 80 percent, 70 percent and 64 percent of dressing changes, respectively.2
These Phase II studies were supported by a grant from ConvaTec.
About Versiva® XC™ Gelling Foam Dressings
Both the Adhesive and the Non-Adhesive versions of Versiva® XC™ Gelling Foam Dressings come in convenient shapes for a variety of wound types. They can be used as primary or secondary dressings, alone or in combination with other wound care products. The Versiva® XC™ Non-Adhesive Gelling Foam Dressing can be cut to shape and size. Both the Versiva® XC™ Adhesive and Non-Adhesive Gelling Foam Dressings consist of three components:
- A waterproof polyurethane foam/film layer that protects the wound from external contaminants and manages moisture vapor transmission of exudates absorbed by the dressing.
- An absorptive, non-woven, fibrous layer of Hydrofiber® Technology that gels on contact with the wound bed to provide a moist wound healing environment and manage exudate spread to the periwound area.
- A wound contact layer. In the Adhesive formulation this consists of a hydrocolloid adhesive border that gels on contact with wound fluid to further support moist wound healing and allow for secure retention. Both the Adhesive and Non-Adhesive formulations allow for gentle dressing removal.
ConvaTec, a world-leading manufacturer of ostomy and wound care products, is at the forefront of the movement to change the way health care professionals are managing chronic and acute wounds. Since the introduction of DuoDERM® Hydroactive® dressing in 1982, ConvaTec has been a pioneer in the establishment of moist wound healing. Today, ConvaTec is building on this strong heritage with its Hydrofiber® Technology, featured in advanced wound dressings such as AQUACEL® Ag dressing, an absorbent, soft, conformable, antimicrobial dressing with ionic silver, which forms a cool gelling sheet on contact with exudate. ConvaTec is a Bristol-Myers Squibb Company (NYSE:BMY ), a global pharmaceutical and related health care products company. For more information, please call 800-422-8811 or visit www.convatec.com.
1. Vanscheidt W, Münter K-C, Klövekorn W, Vin F, Gauthier J-P, Ukat A. A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers. Journal of Wound Care. 2007 June; 16(6): 261-65.
2. Cadden S, Dryjski M, Parish LC; Versiva® XC Pressure Ulcer Study Group. Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers. Int Wound J. 2008 Mar;5(1):60-7.
3. WUWHS. Principles of Best Practice: Wound Exudate and the Role of Dressings. A Consensus Document. London: MEP Ltd, 2007.
4. Griffiths B. Retention of fluid under compression of non-adhesive versions of Versiva® XC vs. Allevyn®, Biatain® and Mepilex®. WHRI2932 TA110. November 28, 2006. Data on file, ConvaTec.
AQUACEL dressing, DuoDERM dressing, Hydrofiber Technology and Versiva dressing are registered trademarks of E.R. Squibb & Sons, LLC.
XC is a trademark of E.R. Squibb & Sons, LLC.
All other brands are trademarks of their respective manufacturers.
* Although all 46 subjects were evaluated for safety, final evaluations for the product’s ability to heal and/or improve exuding leg ulcers, ease of application and removal and ability to sooth were based on 45 subjects. The analysis of mean wound area reduction at final evaluation was based on data from 42 subjects.
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