Wound Care feature: Growth spurt
Wound care is on a tear. As demand continues to build, newer technologies are moving the industry ahead — by the billionsAs long as there have been people there has been wound care. Think of ancient civilizations' use of leeches to manage pain or the Egyptians' grasp of silver's antimicrobial properties. (If prostitution is considered the oldest profession, wounds may be the oldest malady.)
Wound care has evolved beyond primitive techniques, but scientists are still striving to find new ways to cure, treat and prevent wounds. And the market reflects that with an ever-increasing number of new products, technologies and treatment modules.
In recent years, silver dressings and other advanced wound dressings have begun nudging wet-to-dry and other older dressings off the shelves. Other therapies are also gaining solid ground, such as vacuum assisted therapy, ultrasonic debridement and growth factors.
But beyond new devices and treatments, technology also is evolving in terms of understanding proper nutrition and skin care integrity to avoid the possibility of pressure ulcers down the line. And education has never been more important as the government turns the spotlight on pressure-ulcer prevention in long-term care facilities.
Wound care explosion
It's a great time to be in the wound care business. Consider this: The total U.S. market for advanced wound care was estimated at more than $1.7 billion in 2003, according to a 2004 report by BCC Inc. That estimate is expected to rise to $2.8 billion in 2008.
"While conventionally made wound care products are considerable and generally less expensive, new products and biotechnological advancements are beginning to revolutionize the wound care market," the report noted.
What's fueling the growth? Biological dressings, surgical sealants, synthetic dressings and other wound healing products take up most of the market and are rising at an average annual growth rate of 7.2%. Not far behind are wound healing devices, such as oxygen therapies and vacuum-assisted therapies, whose sales are rising at an average annual growth rate of 15%.
The growing popularity of vacuum-assisted therapies is one indication the market is on the cusp of a new generation in wound care, according to Barry Wolfenson, director of marketing and business development for Derma Sciences, a wound care product manufacturer.
The last major revolution in wound care was in the 1980s, when advanced wound care dressings began to replace older wet-to-dry dressings. Since then, the industry has experienced incremental improvements with silver and debriding products. Change becomes evident when once-novel products become more widely available and cheaper, Wolfenson explained. That is happening now with the mass market of hydrocolloids and silver dressings.
"The transition starts when new technologies are developed, forcing older technologies to look like commodities," he said.
Besides the VAC and other mechanized devices, the emergence of active ingredients in wound care dressings is another indication that the industry is transforming, Wolfenson added.
Cynthia A. Fleck, vice president of clinical marketing for Medline Industries Inc., agrees. She predicts there will be more dressings with cyclodextrin to neutralize odors, pain-reducing dressings and bioengineered "smart" dressings. She also expects a surge in collagen dressings, dermal replacements, MMP modulators and other biologics that tackle various issues in the wound bed and surrounding tissue and skin.
In some cases, scientists are looking back to move forward.
Dressings today contain elements, such as silver, that have been part of the wound knowledge-base for centuries. Other old-fashioned remedies, such as maggots and honey, which have moist wound healing properties, are making a comeback.
The wound care market has a captive audience. The aging population and the growing diabetes epidemic are contributing to increases in wounds and their complexity.
"There is still a long way to go in terms of how best to treat these patients," said Kristen Comstock, marketing manager for 3M Skin Health. "Wounds are becoming more complex and patients have comorbidities that need to be considered when treating these wounds."
New, cutting-edge wound care technology is targeting these challenging wounds in the elderly and diabetics. CardioVascular BioTherapeutics Inc., a biopharmaceutical company based in Las Vegas, has a protein product that stimulates the growth of new blood vessels in the heart. It is starting a clinical trial to demonstrate the product's effectiveness in diabetic wound healing. After it proves the product works in diabetics, it wants to test its product on the bed-sore population.
In studies in diabetic mice, the product sped up the wound healing process twice as fast, said Jack Jacobs, Ph.D., who is working on the therapy.
"There's good hygiene and dressing of the wound, but if we could put on the protein growth factor that would double the healing rate of the wound, people would use it," Jacobs said.
Other advancements stand to make a make a huge impact on wound care in the elderly. One that already is making a splash in the long-term care industry is ultrasound mist. Celleration received clearance for its product from the Food & Drug Administration in the spring of 2004. So far in 2006, the company has exceeded the revenues of 2005, said Rick Nehm, Celleration's marketing manager.
"Nursing homes are the focus at this juncture," he said. "We feel that it is the most appropriate use of our technology."
The company currently has more than 200 units in use. Mist therapy, Nehm explained, delivers low-frequency, low-intensity ultrasound to the wound through a mist. The treatments, which promote wound healing through self-stimulation and the reduction of bacteria, can take between 3 and 20 minutes. They can occur three times per week for 12 weeks. The therapy treats wounds including arterial and pressure ulcers.
Unfortunately, reimbursement and payment may prevent some nursing homes from taking advantage of all the new technology available. (See page 41 for related story.)
Know your ABC's
Advancements in wound care are not confined to devices, dressings or molecular technology. Knowledge about the importance of nutrition and proper skin care to prevent wounds has expanded exponentially, and it is expected to grow.
Government regulations are forcing facilities to sharpen their wound prevention knowledge. The new F-314 guidance to surveyors for pressure ulcers, published in late 2004, puts additional pressure on facilities to evaluate a resident's risk factors for developing pressure ulcers and identify areas at risk of constant pressure.
"F-314 will separate the men from the boys in compliance and adhering to CMS guidelines for wound care," said Arnold Gans, president of Medical Nutrition U.S.A.
Nutrition companies such as Gans' have helped to educate facilities on the importance of nutrition, particularly protein, in wound prevention and treatment. Medical Nutrition's Pro-Stat is a concentrated liquid protein product. The protein already is broken down so residents absorb more in their systems.
"Protein should be part of a multidisciplinary approach to the treatment of wounds, where protein intervention and the raising of albumin levels is part of the method of treatment," Gans said.
Advanced skin care products that help to nourish and strengthen the skin to protect it against breakdown also are becoming more readily available. Medline's Fleck says to look for more of these products in the near future as awareness of skin nutrition grows.
"The cosmeceutical industry has known this for years, yet wound and skin care providers are only beginning to utilize these products to address at-risk skin, not just to help cure wrinkles," said Fleck, who also is on the board of the Association for the Advancement of Wound Care.
Because of the stores of knowledge about wounds, companies have gotten into the business of educating as much as selling. This represents a shift, said 3M's Kristen Comstock.
"When we go in and have a conversation with clinicians, we're not talking about a product but what is the best wound care approach," Comstock said. "We are trying to make sure they look at the whole solution, not just a product."
As much as technology is helping to improve wound care, it does not, and will never, replace the basics, experts are quick to remind.
"When it comes to long-term care facilities, there's always going to be innovation in dressings and innovations in advanced technology," said Dr. Roger Schechter of the Palomar Pomerado Health Center for Wound Care and Hyperbaric Medicine in San Diego. "But the reality is that 85 percent to 90 percent of all wounds can be appropriately managed with a common sense approach, that being, number one, adequate nutrition; two, offloading; three, infection control measures; and last, but not least, appropriate dressing selection."
Data and projections for the advanced wound care market:
Advanced wound care products and $1.7 billion $2.8 billion
advanced wound healing devices
Advanced wound care products* $1.1 billion $1.6 billion
Advanced wound healing devices** $0.6 billion $1.2 billion
*Includes biological dressings, surgical sealants, synthetic dressings and others.
**Includes electrostimulation products, hyperbaric oxygen therapies and vacuum-assisted therapies
Source: BCC Inc., Markets for Advanced Wound Care Technologies, December 2004
The cost factor
Sure, dressings are better than ever and the VAC is a major breakthrough. But to what extent are long-term care facilities taking advantage of these new technologies?
Reimbursement and financial constraints are holding them back from using some effective but expensive treatments, experts in the field say.
Hyperbaric oxygen is an increasingly popular wound care therapy, but it is cost prohibitive in many cases.
"Long-term care people don't want to hear about it because of the Medicare payment system," says Dr. Roger Schechter of the Palomar Pomerado Health Center for Wound Care and Hyperbaric Medicine in San Diego. "Unfortunately, the current payment system renders it financially unfeasible."
Some facilities look over more common treatments because of the price, says Les Kiemele, a physician assistant at Gonda Vascular Wound Healing Center, Mayo Clinic, in Rochester, MN. While "there's nothing like" Iodosorb, an iodine gel that is effective at keeping a wound clean and dry, some nursing home facilities in his area won't use it because Medicare does not reimburse for it, he notes.
"It comes down to the home has to supply it or we have to try something else," says Kiemele, who assists seven nursing homes with their wound care programs.
Still, in a pinch he will not hesitate to use the most appropriate treatment.
"For me, personally, I don't let the cost dictate it," he says. "If I feel I need a certain wound care combination, I'll do it. Then you worry about the payment of it later."
Some newer therapies, like Celleration's ultrasound mist, are working to receive CMS approval for reimbursement.
"Reimbursement has an impact on how fast we can bring this technology to patients with wounds," says Rick Nehm, Celleration's marketing manager.
Dr. Robert Bartlett, corporate medical director of hyperbaric medicine for National Healing Corp., is working to see how his wound care centers can be cost effective for the long-term care market. His centers already have made major inroads at hospitals.
In the overall scheme of wound care, the cost of more exclusive treatments could be worth it to avoid more costly problems, such as amputations, experts said. Nursing homes are getting more attuned to this, especially given increased scrutiny by CMS.
"I think many of them are realizing you get what you pay for and they're understanding they need to invest some money into quality products to prevent negative consequences later," says Laurie Rappl, clinical support manager for SpanAmerica, a pressure surface manufacturer.
Adds Diane Johnson of Smith & Nephew: "I think prevention is going to be key. As anyone knows, it's much cheaper to prevent a wound that to treat one."