A new generation of sophisticated products entering the 21st century market should finally put to rest the notion that purchasing wound care products is little more than ordering gauze by the truckload. To the contrary – wound care represents a new frontier for product development as decubitus pressure ulcers, venous leg ulcers and diabetic foot ulcers become more commonplace in an ever-swelling American senior population.

Medline’s TenderWet Wound Care System

During its recent evolution, wound care has grown into two distinct categories – advanced and general, which have coincidentally turned out to be apt assessments of their respective directions: the former is advancing steadily while growth in the latter is generally flat. As a result, advanced wound care has become the preferred environment for product innovation, manufacturers say.

In recent years, manufacturers have introduced a scores of advanced wound care products, including alginate and foam dressings; biocompatible and tissue-engineered skin graft products ("skin substitutes"); antimicrobial and odor-control dressings; film and hydrocolloid dressings; hydrogel and non-adherent dressings; negative pressure therapy; wound-preventing support surfaces; non-occlusive and semi-occlusive dressings; topical wound analgesics and antibiotic formulations; wound cleansers and chemical/enzymatic wound debriders.

General wound care, also known as traditional or acute wound care, has stagnated mainly because of what many consider to be substandard Medicare coverage. The reimbursement climate has become so cost prohibitive that Johnson & Johnson announced last year it was eliminating its general wound care product lines, including eye pads, sponges, gauze pads, tapes and cleaners. Instead, the New Brunswick, NJ-based conglomerate revealed it was "focusing on advanced wound care by pioneering products and technologies that facilitate the healing process."

To be sure, advanced wound care is awash in bullishness. A bellwether report from market researchers Frost & Sullivan, Palo Alto, CA, projects double-digit growth for what it terms "interactive" wound care, defined as "biocompatible products that are intended to actively promote wound healing by interacting either directly or indirectly with wound tissues."

The based research firm estimates the North American market for interactive wound care products generated an estimated $63 million in revenue in 2001 and that the market grew a substantial 34 percent over 2000. Frost & Sullivan projects the market will grow at a compound annual rate of 12 percent through 2008, at which point interactive wound care products will represent 12.5 percent of the total wound care market.

"The market shows tremendous opportunity for growth driven by unmet clinical demands of the elderly population and new technologies with better end results that are entering the market," researchers proclaimed.

The study designates skin substitutes and biomaterial wound dressings as the two major segments of the market. Skin substitutes are defined as "bio-engineered devices that can mimic the structure and function of skin." Biomaterial wound dressings are those that employ organic polymers as the major components.

While skin substitutes are used primarily for the burn market, they comprise 23 percent of wound care market products, the report stated. With an estimated worth of more than $40 billion, researchers say the field is becoming increasingly crowded.

"The market is very competitive – it witnessed high growth in recent years due to new product launches and increasing acceptance of products," report authors said.

The biomaterial wound dressings market generated an estimated $22 million in revenue in 2001 – 25 percent growth over the previous year. Collagen-based dressings currently make up most of the market, though other materials are also being introduced, researchers said.

Evaluating hospitals’ needs

Determining which of the myriad new advanced wound care products are best suited for use in the hospital means assessing recent trends – namely patient migration away from acute care and chronic staffing shortages at healthcare facilities. To vendors such as Minneapolis-based 3M Health Care, new advanced wound care products are being designed to meet these needs.

"The hospital clinicians we talk to say they see sicker patients – those with multiple conditions – and are seeing them leave the hospital quicker," said Gary Ackert, 3M’s business development manager. "Acute inpatient care is still a primary site, however."

Overall though, alternate sites such as home health, skilled nursing facilities and wound care clinics are where the majority of wound care patients now receive treatments, said Jonathan Primer, president of Mundelein, IL-based Medline Industries’ Dermal Management division.

"Hospitals treat and release, which means there is a huge population of ambulatory patients with chronic wounds," Primer said.

Consequently, hospital-bound wound care patients need more intensive treatment than before, further stressing already shorthanded clinical staffs.

"A sicker elderly population requires special care on the staffing side, so there is a need for products to make clinicians more efficient and effective," Ackert said. "Staff members don’t have enough time but they still need to produce excellent outcomes."

Therefore new advanced wound care products are being engineered to heal wounds faster, fit various wound applications and provide maximum usage, manufacturers say.

"Our approach is to improve utilization of our products by requiring the least number of units and providing the longest wear for the dollar," Ackert said. "Improved utilization means fewer dressing changes for the patient. We ultimately want to improve life for the patient, offer help to the provider and deliver value to the payer."

An example of this philosophy is 3M’s new foam heel dressing, designed so that it can be applied with one hand.

"In watching clinicians dress heel ulcers, we found it was difficult for them to stabilize the leg and put the dressing on with the other hand – they either needed assistance or couldn’t apply it properly," Ackert said. "So we developed a heel dressing that could be applied with one hand, thus eliminating the need for two people in the process."

Because heel ulcers are the second most common wound behind sacral ulcers, 3M’s new dressing has the potential to provide substantial relief to labor-strapped hospitals, Ackert said. The dressing can also be used for various other wounds, making it suitable for product standardization programs, he said.

Kimberly-Clark’s wound care line includes adhesive skin closures, island dressings, petroleum impregnated gauze dressings, Xeroform impregnated gauze dressings, oil emulsion dressings, and plain and Iodoform packing strips.They have created a number of products that reduce the risk of adhering to wounds and disrupting the healing process by by conforming to body contours.

Healing wounds

Accelerated healing has become a priority in advanced wound care product development because patient hospital stays are shorter than ever, said Chris Simpson, Medline’s vice president of sales for advanced wound care.

"These products need to make an immediate positive impact on the wounds, because in acute care they only have patient for a couple days before they go home," Simpson said. "They need to minimize patients’ risk before they are released."

Medline is introducing two new product lines designed to be most effective in the acute care environment: TenderWet, a polyacrylate debrider that rapidly clears wounds of necrotic tissue; and SilvaSorb, a cross-linked polymer dressing that uses antimicrobial silver to guard against infections.

TenderWet’s main applications are for vascular wounds, pressure ulcers, diabetic ulcers and contaminated/necrotic wounds. By removing toxins from the wound bed while donating nutrients, the debrider helps enhance and accelerate the body’s own cleansing mechanisms, Primer said.

"The polyacrylate inside the pad has an affinity for large proteins found in wound debris and necrotic tissues," he said. "It takes in the necrotic material and cleans the wound vent by applying Ringer solution."

Silver has long been considered a potent antimicrobial agent and SilvaSorb is intended to serve as an effective barrier to a broad spectrum of microorganisms. The product line comes in a variety of formats for use on decubitus ulcers, diabetic foot ulcers, venous leg ulcers, skin tears, first- and second-degree burns, grafted wounds and donor sites and surgical wounds.

"SilvaSorb uses ionic silver to reduce the bioburden in wounds," Primer said. "Through the controlled release of silver, it kills the bugs without harming healthy tissue."

Negative pressure: another alternative

Amid the skin substitutes, biocompatible dressings and other advanced wound care products is negative pressure wound therapy. San Antonio, TX-based Kinetic Concepts Inc. is promoting its VAC (Vacuum Assisted Closure) system as an alternative for treating chronic and traumatic wounds.

The VAC Therapy system aids in wound closure by applying localized negative pressure to a special dressing positioned in the wound cavity or over a flap or graft. The pressure distributing dressing helps remove fluids and infectious materials from the wound, KCI officials say.

VAC Therapy is designed to promote granulation tissue formation through the promotion of wound healing. Other benefits, according to the company, are that it uniformly draw wounds closed by applying controlled, localized negative pressure; removes interstitial fluid, allowing tissue decompression; and provides a closed, moist wound healing environment.

The system is intended to treat traumatic wounds, chronic open wounds (such as diabetic ulcers and stage 3 and 4 pressure ulcers,) flaps and grafts, subacute wounds, dehisced wounds and partial thickness burns.

Making a case

As is the case with any product category, provider acceptance is the determining factor in the proliferation of advanced wound care products. Thus, it is up to the manufacturers to make a convincing case as to why hospitals are better off using them.

"We need to [build] the image of these products by using an evidence-based approach with decision-makers to show that these technologies result in better outcomes," Ackert said. "It gets back to improved utilization, durability and wear time. We’ve made it mandatory that products be more than just clinically preferred, they have to bring value."

Reimbursement is also an issue, though manufacturers say it’s not as influential in advanced wound care as it is for general wound care.

"It’s clearly a barrier and a consideration," Primer said. "But anytime you introduce a new product it has to perform so well that reimbursement won’t make a difference even though you hope it will happen."

If reimbursement is inadequate for general wound care products, it’s nearly non-existent in the advanced wound care sector. Vendors don’t expect that scenario to change anytime soon, but they so far they don’t sound discouraged.

"You can’t let the lack of reimbursement detract you from developing new technology," Ackert said. "It would be great to have, but you can’t wait for it." HPN

Cited by Frost & Sullivan as a major segment of the advanced wound care market, tissue-engineered skin graft products, or skin substitutes, are designed primarily for treating severe burns, but also are being used to treat particularly stubborn ulcer wounds. Manufacturers are using various techniques to develop their respective skin substitute brands, some of which are detailed below:

• Alloderm – Comprised of human cadaver tissue, it debrides the wound while preserving existing live tissue. Offered by Branchburg, NJ-based Lifecell Corp.

•Apligraf – Manufactured from living human fibroblast cells, it is approved for treatment of venous leg ulcers and diabetic foot ulcers. Manufactured by Canton, MA-based Organogenesis (Novartis), it is intended for use with standard compression therapy.

•Dermagraft & Transcyte – Human fibroblast-derived skin substitutes from Largo, FL-based Smith & Nephew. Both products employ bioabsorbable scaffold as a platform for active living cells to replicate. Cells attach and multiply to fill the spaces within the scaffold.

•Integra – System uses a porous, biodegradable scaffold for dermal regeneration. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen. Available from Plainsboro, NJ-based Integra Life Sciences (affiliated with Johnson & Johnson).

•Oasis – Extracellular matrix comprised of "natural growth factors" and collagen. Classified as an exotic dressing rather than a skin substitute. Distributed by Fort Worth, TX-based Healthpoint.

•OrCel – A bilayered cell matrix product derived from human cells, containing cultured neonatal human keratinocytes and fibroblasts in separate compartments of a collagen sponge. Developed by New York-based Ortec International. HPN