BB&T Contributing Editor
TORONTO — The World Union of Wound Healing Societies (WUWHS; Castres, France) represents 26 wound healing societies from countries around the world. Its board includes opinion leaders in wound care from Australia, Belgium, Canada, France, Denmark, the UK and U.S. The WUWHS congress, which is held at four-year intervals, is touted as the world's largest conference dedicated to wound management.
The third such gathering, whose motto was "One Problem One Voice," drew 3,500 attendees from 71 countries to this dynamic Canadian business center in June. The next meeting will be held in Yokohama, Japan, in 2012.
The congress had a distinctly international flavor, from its opening ceremony which featured a band of marching bagpipers, to the presentation of lifetime achievement awards to recipients from 10 countries for contributions to the advancement of wound management.
Also featured was an impassioned keynote address delivered by Stephen Lewis titled "Humanitarian Concerns for the Developing World," which focused on the wounds suffered by abused women in several African countries. Lewis lavished praise on the nurses who work in severely understaffed healthcare facilities and who often serve in the role of physician in the Congo, Liberia and Zimbabwe, among other developing countries.
Negative pressure therapy advances
Cathy Burzik, president/CEO of Kinetic Concepts (KCI; San Antonio), reviewed the company's strategic business areas, at the center of which is its industry-leading V.A.C. vacuum-assisted devices, which employ negative pressure wound therapy (NPWT) for healing acute, traumatic and chronic wounds and are marketed in 20 countries. The company is currently focusing on entering the Japanese market.
The V.A.C. system is supported by 17 randomized and controlled clinical trials and 137,000 caregivers have been trained in its use.
The first comprehensive publication of international best practices for the use of V.A.C. Therapy was introduced during the WUWHS congress. The document, "Principles of Best Practice — Vacuum Assisted Closure: Recommendations for Use," was developed by an international working group to provide guidance on the integration of V.A.C. Therapy into clinical practice for the treatment of six selected wound types.
The initiative draws on the clinical research evidence and the best practice opinions of 26 international wound care experts in the group.
"Studies show that V.A.C. Therapy has helped to improve wound care outcomes and has led to a number of dramatic changes in clinical practice over the past decade," said Professor Keith Harding, co-chair of the working group and head of the Wound Healing Research Unit at Cardiff University in Wales. "This timely initiative ... specifically reviews V.A.C. Therapy's potential use for a number of indications."
The consensus document outlines recommendations for the use of V.A.C. Therapy in diabetic foot ulcers, complex leg ulcers, pressure ulcers, dehisced sternal wounds, open abdominal wounds and traumatic wounds.
KCI featured its new smaller, lighter and mobile systems, InfoV.A.C. and ActiV.A.C., which have touch-screen features. InfoV.A.C. can store pictures of the wound and the Acti V.A.C. system is for home use. The annual cost in the U.S. for treating patients with pressure ulcers is estimated to be $11 billion and there are 62,000 deaths annually from hospital-acquired pressure ulcers.
Another primary business segment at KCI is therapeutic surfaces and includes mattress replacement systems, overlays and hospital beds to help prevent and treat pressure ulcers.
A third core business is represented by KCI's recent acquisition of LifeCell (Branchburg, New Jersey) for $1.8 billion, whose AlloDerm acellular human tissue matrix is obtained from cadaver skin from which DNA has been removed. It is used in hernia repair and breast reconstruction, procedures in which the V.A.C. equipment is commonly used.
LifeCell makes sales calls on operating room personnel but KCI does not, thereby opening a new sales channel. Additionally, LifeCell has sales only in the U.S., so KCI can expand its products into the European market.
Strattice, LifeCell's newest product, is a sterile reconstructive tissue matrix derived from porcine dermis that supports tissue regeneration.
Smith & Nephew Wound Management (Hull, UK/St. Petersburg, Florida) entered the negative pressure wound therapy market with its acquisition in May 2007 of Blue Sky Medical's (Carlsbad, California) EZCare system and Vista, a portable version for ambulatory use.
The company introduced Biostep, a collagen matrix dressing that is promoted as removing barriers to wound closure while maintaining an optimal moist wound environment. It will compete against the Promogran matrix wound dressing, comprised of oxidized regenerated cellulose and collagen, from Johnson & Johnson Wound Management, a unit of Ethicon (Somerville, New Jersey). J&J is in the process of divesting the wound care business.
Smith & Nephew added the Site brand dressing for use with percutaneous devices to its Acticoat antimicrobial barrier product line. Allevyn foam was added as a line extension to Allevyn Ag, a hydrocellular antibacterial dressing, and Allevyn Gentle, a silicone gel absorbent foam dressing that was launched at the conference.
Medela Healthcare (McHenry, Illinois) featured the Invia healing system, a negative pressure wound therapy system for healing chronic and acute wounds. It is used with a wound-healing kit to remove infectious materials and to mechanically stimulate tissue to promote wound healing.
Medela's new Liberty pump, part of the Invia wound therapy system, weighs only 2.2 pounds and is portable. FDA clearance is pending for this product.
Synergy Healthcare (Oldham, UK) markets in Europe its Exsudex negative pressure wound drain-age system, and Exsu-Seal, an adhesive hydrogel seal that is placed around a wound's edges to prevent leakage. It is used with the Exsudex system for treating pressure ulcers in the sacral area.
Talley Medical (Romsey, UK) recently filed a 510(k) submission for Venturi, a negative pressure wound therapy system. It features a predictive low vacuum warning system that continuously monitors vacuum pressure for the early detection of any environmental air leakage through the dressing which could dehydrate or contaminate the wound.
The company is exiting from its business in support systems, which includes mattresses and cushions, due to competition from Chinese suppliers.
ConvaTec (Skillman, New Jersey) was acquired in early August for $4.1 billion from Bristol-Myers Squibb (New York) by the private equity firms Nordic Capital (Stockholm) and Avista Capital Partners (New York). It introduced Versiva XC, a non-adhesive gelling foam dressing to replace traditional foam dressings that is designed to protect periwound skin and reduce the risk of maceration.
Mölnlycke Health Care (Gothenburg, Sweden) had one of the largest exhibits, although it has a small presence in North America compared to the European market. The company had supported an educational initiative of the WUWHS which resulted in a best practices document titled "Minimizing Pain at Dressing-Related Procedures," which contains expert opinions from world-renowned wound care specialists. Pain has a major impact on the quality of life of patients suffering from chronic wounds.
The company had reported in March the results of a multi-national survey published in the Wounds UK journal. It found that the use of Mölnlycke's Safetac soft silicone adhesive technology resulted in reduced pain at dressing changes, as compared to advanced dressings with traditional adhesives. The technology consists of a thin layer of soft silicone which attaches to the skin. The company has introduced a series of dressings using this technology under its Mepitel, Mepilex, Mepitac and Mepiform brand names.
Oculus Innovative Sciences (Petaluma, California) markets Deramcyn for debriding and cleansing of wound ulcers, acute wounds, burns and abrasions. It is a solution of hypochlorous acid and is based on the company's Microcyn technology. The company continues to advance its U.S. clinical program for drug approval of its technology for the treatment of mildly infected diabetic foot ulcers.
Advancis Medical (Nottingham, UK) markets in Europe its Activon medical grade Manuka honey for wound healing with claims of antibacterial activity. It is sold several forms, dispensed from a tube, impregnated in a viscose non-adhering wound and impregnated in an absorbent calcium alginate dressing. Honey draws out lymph fluid from the wound tissues via osmosis. The company is seeking a U.S. distributor for these products.
Advancis also sells Silfix soft silicone adherent dressings for use on friable or sensitive skin. It does not stick to a moist wound, only to surrounding dry skin.
Derma Sciences (Princeton, New Jersey) featured its Medihoney wound and burn dressing that contains active Manuka (Leptospermum) honey from New Zealand. That is impregnated into an alginate pad. The product was the subject of 11 posters which reviewed clinical test results on a variety of wound types.
Line extensions will include adhesive and non-adhesive hydrocolloid-containing honey and honey packaged in a tube. The honey is intended for use in all stages of wound healing. It is believed to have antimicrobial properties, but that claim cannot yet be made in the U.S.
Electrical and acoustic devices
Derma Sciences will launch later this year Mobility I, an intermittent pneumatic compression device for lymphedema and chronic venous insufficiency that will allow for patient mobility. The product was licensed from C-Boot Ltd. (Haifa, Israel). It employs a dynamic compression booty that is driven by a pump in the heel. It is intended for patients that are ambulatory and have not benefited from static compression.
Talley Medical markets the Multipulse 500 pneumatic compression system for treating chronic wounds and venous disorders. Its peristaltic wave action mimics one of the body's natural functions and operates by always having one pressurized chamber holding behind the inflating chamber to keep fluid moving proximally and to avoid reflux.
Harding's working group has issued another consensus document titled "Principles of Best Practice: Compression in Venous Leg Ulcers," which was distributed at the conference. It was developed to help clinicians meet the challenges of achieving effective compression. The Cardiff University professor characterized compression as the cornerstone of management of many patients with lower leg wounds.
FlowAid (Netanya, Israel) markets FA100, a self-contained portable muscle pump activation device designed for home use. It supports the body's circulatory system through a venous muscle pump that increases local blood flow and temperature in the lower extremities. The FA100 produces a specific stimulation which is transmitted to the underlying muscle group through four electrodes placed on the skin.
The stimulation induces a sequence of contractions in a peristaltic wave form along the muscles distal to proximal. The product is used to improve the symptoms of lymphedema, for treating diabetic and venous stasis ulcers, and for the prevention of deep vein thrombosis. FA100 is sold in Europe and Asia but is not approved for sale in the U.S.
Ivivi Technologies (Northvale, New Jersey) manufactures Roma3, pulsed electromagnetic field therapy equipment that induces a microcurrent in injured tissues to enhance the body's normal electrochemical processes. Treatment is applied through dressings, casts or clothing. It is indicated for use on pressure sores, vascular ulcers and diabetic ulcers, as well as burns and acute wounds. It is distributed by T.H.E. Medical (Orlando, Florida, and Barrie, Ontario).
LifeWave (Tel Aviv, Israel) sells in Europe its BST (Best Sore Treatment) electrical stimulation device for treating chronic, ulcerated wounds. It uses a proprietary wave to stimulate wounds and is based on a specific biocurrent that was identified for healing wounds. It was described as treating crosstalk between wounds and the central nervous system. BST was launched at the conference for the Canadian market. FDA clearance will be sought for the U.S. market.
Sanuwave (Lengwil, Switzerland) displayed its dermaPACE device, which applies pulsed acoustic cellular expression for use on difficult to treat wounds. Its high acoustic pressure waves elicit a cellular response that initiates healing in acute and chronic wounds. The product was launched in Europe one year ago and is in an investigational device exemption clinical trial in the U.S. for the treatment of diabetic foot ulcers.
Phototherapy for wound healing
MedX Health (Mississauga, Ontario) uses light from a portable and low-level laser to stimulate tissue repair and for the control of acute and chronic pain. The laser light was shown to be an effective treatment by increasing blood flow, accelerating tissue repair and reducing inflammation and edema.
The company now is entering the market for treating venous stasis and diabetic foot ulcers and has systems for use by physicians and for home use. The phototherapy is applied for one to five minutes daily, depending on the size of the wound, for a period of one week. Visible red (633 nm) and infrared (785 nm and 870 nm) low-level laser diodes are used. Photons produced in the 600 nm to 1,000 nm range have been shown to penetrate tissue and to be absorbed at a cellular level. A series of photochemical reactions occur resulting in enhanced tissue healing, pain control and stimulation of the vascular, immune and lymphatic systems.
MedX is developing the PhotoBandage, which contains a light source in the bandage and would eliminate the need for a dressing change when applying phototherapy. The company recently launched OraLase, a dental laser. MedX completed a public offering on the Toronto Stock Exchange in February.
Biologics for wound healing
Vivostat (Alleroed, Denmark) markets in Europe its Vivostat Fibrin, a tissue sealant, and Vivostat PRF, a platelet rich fibrin, for healing wounds. These autologous products are prepared from the patient's whole blood using a fully automated process and different software packages in a 23-minute procedure. The products are applied to the wound site using a spray pen.
ReGen Lab (Mollens-VD, Switzerland) sells the RegenKit for collecting an autologous platelet gel that is injected and used for tissue regeneration. The platelets deliver growth factors in their biologically determined ratio. The platelet-rich plasma is collected at the point of care from bone marrow or peripheral blood in a 10-minute process. Applications include the treatment of chronic and surgical wounds and for rejuvenating aging skin.
The ReGenKit is marketed to physicians worldwide and the company said it expects to enter the U.S. market this year. ReGen Lab also is developing Albugel, an autologous protein gel for the prevention of post-op adhesions.
Archimed is a division of Insense (Bedford, UK), an R&D-based company. Oxyzyme is used to restore oxygen balance and accelerate wound healing. An oxygen gradient is created by combining glucose and glucose oxidase contained in crosslinked hydrogels. This combination generates hydrogen peroxide which breaks down to yield oxygen.
It also contains iodide ion, which is transformed through ion exchange to yield molecular iodine, an antimicrobial agent that creates a bacterioostatic environment. Iodozyme contains a higher iodide concentration and can be used to encourage healing of infected wounds. These products can be used on all forms of shallow chronic and acute wounds. The dressing maintains a moist wound site if covered with a breathable dressing.
Archimed sells its products in Europe and has the registration needed for sales in Canada. FDA clearance is expected by the end of 2008.