Leveling the Wound-Care Playing Field

As a new year begins, we are faced with new challenges to our ability to treat patients with chronic wounds. One of the most recent documents, published this past December, addressing that issue is a comparative effectiveness review of all the treatments of venous ulcers.¹ This was done by the Johns Hopkins Evidence-Based Practice Center, Baltimore, MD, at the request of the Agency for Healthcare Research and Quality of the U. S. Department of Health and Human Services. In the review, all reported treatments of venous ulcers including all types of dressings, topical antimicrobials, compression bandages, cell therapy, and venous surgery were evaluated as to their ability to heal venous ulcers based on current literature. After evaluating more than 10,000 articles, only 60 studies were included. The findings were not surprising for an evaluation of this type. According to the studies reviewed, there was not enough evidence to suggest that any of the advanced wound dressings, antimicrobials, or venous surgery were beneficial in healing of venous ulcers. The only treatments that showed a statistical improvement in healing were compression bandaging and cellular human skin equivalents.   I am all for studies comparing the effectiveness of one product to another, but for this to be meaningful, the products must have a similar effect on the wound and wound healing, and be used for their intended purpose. We are all aware that for a wound to heal, it must progress through 4 separate stages of healing. Each of these stages involves a carefully orchestrated set of events that must occur in the appropriate order if the outcome is to be progression of healing. We know, too, that each stage of healing has multiple points at which the healing trajectory can be interrupted. These events interrupting the healing may be systemic factors or local factors, or both.²   Many, if not most, of the dressings and treatments we use in caring for wounds are not designed to be all things to all wounds. They are designed to treat one particular problem in the wound healing scheme so that the wound can overcome one healing obstruction and progress to the next if there is one. For that reason, very few of the wound products evaluated are designed to heal the wound, just to move it down the healing trajectory so that the next product can manage the next issue. It is no wonder, then, that the studies found few products that actually healed the chronic venous ulcer. We are asking the products to do things they are not intended to do.   A second issue is the definition of benefit outlined by the U. S. Food and Drug Administration (FDA) for products used in the treatment of chronic ulcers. The FDA has required that all wound care treatments result in “complete wound closure” if they are to be considered effective.³ This has resulted in many effective products and treatments being labeled as “ineffective” when actually they were able to improve the wound and result in partial healing or even improve the quality of life. Recently, Eaglstein, Kirsner, and Robson³ addressed this issue and encouraged the FDA to reconsider their endpoints for wound care products and treatments. There may be some hope that the FDA is listening. In an early December 2013 meeting with the FDA about a wound treatment, I was told that they would consider the percent of healing of the wound as the endpoint and not require “complete wound closure” for the clinical trial with the treatment. This will help level the playing field when it comes to effectiveness of treatments of chronic wounds.   There is no question that comparative effectiveness studies will be a major part of our future in wound care. The final conclusion of the paper suggested we as wound care providers and researchers should work to standardize the designs of the clinical trials and the endpoints of the treatments so that valid conclusions can be produced. Unfortunately, wound care trials do not easily lend themselves to the same type of procedures and designs as drug trials, but we must do better than we currently are. Perhaps working with the FDA can result in reasonable compromises that can provide us with beneficial information about products and treatments that is beneficial while providing the evidence that is needed.