XCell wound dressing from Medline

With pressure ulcers and other wounds plaguing up to 10% of all hospitalized patients and costing more than $5 billion annually to treat, it’s little wonder that wound care itself has become a board certified specialty — and that the demand for cutting-edge wound management products has reached a fevered pitch.

Vendors are meeting those demands with a diverse and dynamic array of products that speed healing, reduce pain and discomfort, eliminate the risk for infection and minimize scarring. And that’s just the tip of the iceberg. Sources told Healthcare Purchasing News that aside from these key clinical factors and positive outcomes, many of today’s innovative formulations provide even greater value by maximizing caregiver resources and minimizing supply costs.

"It seems that the demands of financial decision-makers in wound care are now [being considered right alongside] the clinical demands," said Gary Ackert, marketing manager, 3M Skin Health, St. Paul, MN. "There is becoming more of a demand for both good health outcomes and cost-effectiveness, and responsible manufacturers are working to meet those demands."

The thriving wound care market supports that claim. According to reports from market research firm Frost & Sullivan of Palo Alto, CA, revenues for the advanced wound management products market will continue to grow at a compound annual rate of 26.9% and will reach an estimated $2.4 billion in 2006. That figure represents a substantial increase over the $455 million market in 1999 – a surge that analysts attribute in great part to an aging and sicker patient population that is more prone to skin breakdown and infection, increasing penetration into the non-acute care market and growing competition amongst product manufacturers.

That’s not to say that demand for traditional dressings is subsiding, however. Market analysts generally agree that this segment will continue to thrive in light of reimbursement challenges and the higher costs associated with advanced wound management products that could restrict their widespread adoption. Clinicians’ reluctance to switch from their traditional wound care staples is also a key factor.

"While the wound care market holds significant potential in terms of financial growth and technological advancements, the primary obstacle facing manufacturers is the care provider’s reluctance to adopt new technologies and products," noted Frost & Sullivan in its report Strategic Analysis of Global Wound Care Markets.

Silver market shines
One development in the wound care market that has caught on with clinicians is the impregnation of products with an antimicrobial to reduce the risk of nosocomial infection.

Numerous studies point to the benefits of using antimicrobial silver products to treat advanced wounds, particularly in patients with a higher risk factor for skin breakdown, slow healing and infection, such as diabetics and the elderly. Silver-releasing dressings are not a new concept. When silver sulphadiazine was introduced in 1968, it was recommended as a topical treatment for the prevention of pseudomonas infections in burns. Since then, it has been demonstrated to possess broad-spectrum antibacterial, antifungal and antiviral properties, and is being used in much broader clinical applications.

"Advanced wound care products with antimicrobial silver promote an optimum environment for healing. I believe most patients with an [advanced] wound could benefit," said Jonathan Primer, president, Advanced Wound Care Division, Medline Industries, Mundelein, IL. He noted that the recent death of actor Christopher Reeve, whom died from complications stemming from an infected pressure ulcer, further underscored the risks associated with advanced wounds and the value of developing and adopting products that can reduce the risk of infection.

Facilities may be surprised to learn that silver-impregnated products don’t have to cost a premium. Depending on the product, Primer said many silver dressings only cost between 10-15% more than non-antimicrobial versions.

Medline markets the SilvaSorb antimicrobial silver products, including a single-use wound dressing and a hyrdogel that eliminates the need for topical antibiotics. The dressing couples sustained release ionic silver with Microlattice, a product with skin-like characteristics that enables the SilvaSorb dressing to provide moisture when required or absorb up to five times its weight in wound leakage. The products are intended for chronic wounds, such as those that occur in diabetics or the elderly.

Valerie Johnson, product manager for Coloplast Corp., Marietta, GA, said recent clinical studies show that products with a sustained release of silver "are more beneficial than those that offer a single dump of the [antimicrobial]." Coloplast’s Contreet product line includes antimicrobial foam and hydrocolloid dressings that use advanced moist wound healing silver technologies with silver as the active component. The clinical studies demonstrate that Contreet products provide seven days of sustained release levels of silver that are greater than the MIC for common wound pathogens, increasing the effectiveness of wound healing.

In 2003, silver made its way into the suture market with the approval of ETHICON Inc.’s VICRYL Plus Antibacterial sutures. The development makes sense to many surgeons and hospital administrators who are keenly focused on reducing SSIs and are committed to the cause by adhering to stricter guidelines and exploring promising new surgical wound products and protocols. SSIs account for 17% or 500,000 hospital-acquired infections each year and can cost several thousand dollars or more per incident to treat.

"There are a number of practical issues related to the use of antimicrobial sutures, particularly when one understands that surgical site infections are quite common and occur in approximately 2-3% of all surgical [patients]," explained Dr. Henri Ford, chief, division of pediatric surgery and surgeon-in-chief for Children’s Hospital of Pittsburgh.

"The antimicrobial suture is a novel and exciting concept because it provides a way to inhibit bacteria from colonizing at the point of wound closure," he continued.

A study conducted at the American College of Surgeons Clinical Congress found that 74% of surgeons believe implantable antibacterial devices, such as antibacterial sutures, may help reduce SSIs, and 82% indicated that, if given the choice, they would use antibacterial sutures over standard ones.

Aside from silver, some companies, including Medline and Tyco Kendall, are adding a broad-spectrum antimicrobial agent called polyhexamethylene biguanide (PHMB) to their dressings. With PHMB, bacteria are inhibited in the dressing upon absorption of wound fluid rather than through the release of the antimicrobial agent. PHMB has been found to be particularly effective in highly exudative wounds that are contaminated or colonized with resistant organisms because it serves as a barrier that prevents bacteria from spreading beyond the wound. Studies show PHMB is effective in inhibiting the growth of a broad range of organisms, including methicillin-resistant S. aureus, vancomycin-resistant Enterococci and fungi.

3M Tegaderm clear dressing

Focus on healing, comfort
Wound management products that offer greater flexibility, durability, breathability and comfort are also capturing the attention of clinicians.

According to Jess Carsello, vice president of sales for Grand Rapids, MI-based Aspen Surgical Products Inc., there’s a growing interest from end users for wound dressings that combine an effective, breathable adhesive with a flexible fabric.

"The key to skin-friendly pressure-sensitive adhesives is to allow breathability that will help maintain intact skin and promote effective, healthy healing," he said. Aspen Surgical, which recently acquired Sterion Inc.’s medical products division, manufactures a range of disposable medical products for the surgical environment, including wound closure and wound drainage products.

Flexibility and patient comfort has been the driving force behind Medi-Tech International Corp.’s products. Its Spandage stretch bandage line was designed to replace all other bandages and devices by holding any wet or dry dressing or compress firmly in place on almost any part of the body. Spandage gives the patient greater freedom of movement, eliminates tape excoriation problems and tape residue on the skin, as well as the pain associated with adhesive tape removal. The product works well with hydrogels, such as Medi-Tech’s hydrogel dressing sheets, however, Spandage also works well with plain gauze, noted Medi-Tech’s vice president of sales and marketing Vicky LaMantia.

Developing products that increase patient comfort is becoming even more important in light of healthcare standards that require facilities to do a better job of managing and controlling pain in their patients. Fortunately, many wound care products that aid patient comfort also pull double duty by offering longer wear time, which translates into less time spent changing dressings.

3M Tegaderm clear dressing

In September 2004, 3M added the Tegaderm Absorbent Clear Acrylic Dressing to its product portfolio. The dressing allows clinicians to monitor pressure ulcers, skin tears and other moderately exuding wounds without changing the dressing. Fewer dressing changes may also reduce supply costs, cut nursing time and provide better patient comfort.

"Customers told us they wanted an easy-to-use dressing that provided transparency and absorbency, as well as a dressing that didn’t have a hydrocolloid-related odor or dressing breakdown in the wound," noted Pat Oatman, marketing manager, 3M Skin Health. "Tegaderm delivers all that. Clinicians can observe the wound through the dressing and still manage fluid without removing the dressing. Of course, the patient also benefits because less manipulation means [less discomfort]."

Eye on interactive concepts
Another segment of the wound management market that is gaining momentum and showing great promise is so-called interactive products.

Bio-engineered skin substitutes and products that use alginates, hydrocolloids and materials containing collagen or hyaluronic acid comprise the interactive wound care segment. Not only do these products help keep wounds moist, they are also believed to promote healing by interacting with cells or matrix proteins in the wound bed and recreating the desired physical and chemical properties of the dermis.

While interactive wound care products represent a relatively small percentage of the overall wound management market – quite possibly because of the higher price associated with the cutting-edge technology — sources predict they will become increasingly popular as healthcare organizations begin to look at products’ overall value rather than solely the purchase price.

"There is real value in using technology, such as biosynthesized cellulose, that can adapt to different wound environments by either donating or absorbing [fluid] when needed," explained Primer. He predicted that in five to ten years there will be a growing trend toward using bioengineered materials that can not only protect wounds, but also aid in their healing. "Products that introduce human growth factors into the wound bed, for example, could potentially change the face of wound care."

Of course, as history has proven, more widespread acceptance form the healthcare community will require more than an effective formula. As Ackman put it, wound care manufacturers can’t afford to provide just clinical problem-solving. "Manufacturers will face increasing demands for evidence that their products provide both a clinical and health-economic benefit," he said.

Prevention pays
While today’s products are indeed leading to more effective, efficient wound management, sources stressed that still doesn’t diminish the importance of being proactive and working to prevent wounds from surfacing in the first place.

Johnson said Coloplast has long been focused on comprehensive, preventive skin care that can reduce or even reverse the development of wounds.

"Not every wound can be prevented, but we believe it is critical to treat the skin as the vital organ it is and provide clinical education [care providers] across the continuum to try and prevent wounds wherever possible," she noted.

Primer said education and guidance are critical components of any effective wound management program, particularly because many wounds are treated outside the outpatient setting where caregivers’ access to information related to products and care for different types and stages of wounds is limited.