Editor`s Opinion: A New Year: A Therapeutic Future for Wound Care?

    Is it possible, after many years of discussion and debate, that 2006 will be remembered as the year wound care moved into the 21st century? I am not talking about the massive eradication of gauze-based dressing protocols or the worldwide adoption of fancy new treatment modalities. In order to move into the 21st century, we first must jettison the 20th century product classification that has stifled progress. To help you start this new year — the beginning of our therapeutic future — here is a brief overview of the problem and its side effects and suggestions for ways clinicians can be part of its resolution.

    Although the market for chronic wound care products is expected to surpass $5 billion by 2009, we continue to describe and classify these products based on a practice that originated in the late 1970s — ie, according to the main ingredients or physical features.¹ This practice has become firmly cemented in reimbursement categories, hampering real progress in wound care for a variety of reasons. First, it has enabled the vast majority of wound care products to be marketed with limited (if any) evidence of clinical safety, effectiveness, or other clinical outcome of interest. Case-in-point: How often have you heard or read the phrase “controlled clinical studies are needed”? Most dressing manufacturers once were required, at the very least, to submit evidence of substantial equivalence to a pre-existing product (usually the first generation of “modern” dressings or, believe it or not, gauze). Since passage of the 1997 US Food and Drug Administration (FDA) Modernization Act, almost all dressings now are classified Class I exempt.² This means manufacturers are not required to submit evidence of safety, effectiveness, or other outcome to the FDA before marketing a new or changing an existing product. Products are marketed first and evidence of their safety and effectiveness may or may not follow. Meanwhile, dressing physical characteristics, usage criteria, and product indications can vary considerably within each so-called “category”.^3-5

    This leads to the second major barrier to progress: Why should clinicians, accustomed to prescribing products based on what they do, be asked to select products based on a main ingredient or physical characteristic? For instance: a patient presents with a shallow wound with a moderate amount of exudate. Wouldn’t life be so much easier if we simply could select a product that has been shown in clinical studies to absorb exudate and facilitate re-epithelialization? Thus, instead of thinking which category of dressings and which dressing within that category might “fit the bill,” we could chose a product approved for “re-epithelialization” and “exudate management.”

    Third, attempts to fill our current evidence gap through meta-analyses and in-depth reviews continue to disappoint — in some circumstances because current categories contain products that, for example, may feature different characteristics or contain different ingredients.⁴ You only have to listen to a manufacturer describing how a product is “really different” from others in that category because it contains a different ingredient, more of an ingredient, or a better adhesive to know you are not being presented an apples-to-apples comparison.

    Sadly, the current state of confusion is getting worse, not better. Witness the bewilderment surrounding “dressings with drugs” and “adjunctive treatment modalities.” Following the same physical description or mode of action pattern established almost 30 years ago, most of us know how some “adjunctive” modalities function and have read case reports about their use. Yet we are unsure about their exact fit within our wound care armamentarium.

    This issue of OWM highlights the confusion and debate about silver-containing dressings. Sometime this year, the FDA will probably classify “dressings with drugs” as Class II devices. In addition to continuing the folly of categorizing a dressing by ingredient (“any drug”), the class designation means that clinical studies are generally not needed and the FDA will rely on well-designed bench and/or animal testing.²

    This brings us to the clinician’s roll in moving wound care into the future. First, we can help ensure current FDA classifications are correct. The FDA’s position regarding device classifications is based, in part, on the absence of evidence that these devices can cause adverse effects. Because few studies examining safety have been published and few adverse event reports are received, the FDA assumes all is well. Therefore, if you suspect an adverse event (eg, skin irritation, infection, wound deterioration) might be product-related or if a device malfunction causes problems, you should report it to the manufacturer or to FDA. To report the incident to the FDA, log on to MedWatch at https://www.accessdata.fda.gov/scripts/medwatch/. To report an incident to the manufacturer (who must, in turn, notify FDA), call them or send an email.

    Second, given the absence of progress in this area and increasing demands on clinicians to provide evidence-based care, clinicians must stop using products that lack safety and effectiveness data — now. Your purchasing agent may have been told that a particular product is similar to one for which clinical outcomes data is available (except this one is cheaper and better, of course), but you, the clinician, can easily dispel this myth. A simple comparison of all ingredients, claims, indications, and other product information will most likely reveal important differences between products within each reimbursement category; thus, clinician assumption that safety and effectiveness profiles are similar is an unwise leap of faith. If the purchasing agent does not agree, get Risk Management involved.

    The collective pursuit of evidence will have profound short- and long-term consequences. Short-term, all patients will be provided evidence-based care. Long-term, the number of manufacturers who insist on selling the sizzle instead of the steak will decrease while long overdue, adequately powered, randomized, controlled clinical studies will finally be conducted. This, in turn, will help us fill in the blanks in our clinical classification paradigm — a paradigm familiar to clinicians and based on function, not features. We know what wounds need. What we need are products found to be safe and effective for re-epithelialization, debridement, exudate management, granulation tissue formation, and other wound care functions.^3-5 Is that too much to ask in a century of unprecedented technology and innovation?

    Wishing you all a happy and healthy 2006. Let the future begin!

1. Kalorama. Wound care market for skin ulcers to pass $5 billion by 2009. Available at: http://www.kaloramainformation.com/press. Accessed December 7, 2005.

2. United States Food and Drug Administration. Information from FDA on dressings with drugs. Available at: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005. Accessed November 9, 2005.

3. van Rijswijk L, Beitz J. The traditions and terminology of wound dressings: food for thought. J WOCN. 1998;25:116–122

4. van Rijswijk L. Ingredient-based wound dressing classification: a paradigm that is passé and in need of replacement. J Wound Care. 2006;15(1):11–14

5. Ovington L, Peirce B. Wound dressings: form, function, feasibility, and facts. In: Krasner DL, Rodeheaver GT, Sibbald RG (eds). Chronic Wound Care: A Clinical Source Book for Healthcare Professionals, 3rd ed. Wayne, Pa: HMP Communications;2001:311–319.