I Do Not Like Green Eggs and Ham

My new hobby is taking pictures of used dressings. Based on my observations, it seems like it is more difficult to control wound bioburden today. Is it just my imagination, or is the drainage from chronic wounds more and more resembling substances that come out of a preschooler’s nose? Nearly a decade ago, a consortium of dressing manufacturers wanted to better understand the drivers for the use of antimicrobial dressings. For that project, we analyzed 7,099 wounds in the U.S. Wound Registry (USWR). The average wound size was surprisingly large at 19.5 cm², and because the majority of wounds had moderate to high levels of drainage, 80% of all dressings used were in an absorbent category.¹ Antimicrobial dressings were used at some point in 71% of wounds. By the time an antimicrobial dressing was first applied, a wound had been present an average of six months, so it’s not difficult to understand why they were heavily colonized. The USWR has structured data on more than two million visits that include wound measurements, tissue type exposed, drainage amount, drainage color, odor, percent granulation, slough, etc. For each of these encounters, the primary and secondary dressings selected are recorded. Detailed data like this enabled us to determine that, 10 years ago, clinicians initiated antimicrobial dressings in response to specific clinical indications such as odor, green drainage, or periwound erythema. Importantly, antimicrobial dressings were usually stopped after about 2-4 weeks because those indicators had resolved. However, I don’t think we would find the same thing if we repeated the study today. I just can’t seem to get control of all the smelly, green drainage.

In 2016, members of an advisory panel for the U.S. Food & Drug Administration (FDA) evaluated the use of antimicrobial dressings. They were very worried about silver resistance and kept asking attendees if we were seeing it in clinical practice. How would we know? The hospital microbiology lab doesn’t report silver resistance on a bacterial culture, and I am pretty sure Medicare wouldn’t pay for a special “silver resistance” test, even if I could get it. In my testimony to the FDA, I explained that 52% of wound care patients are prescribed systemic antibiotics, usually more than once during their course of care and often intravenously. Furthermore, nearly 10% of patients receive topical antibiotics, so I wasn’t sure why the FDA was worried about resistance to small doses of topical silver. Despite all the admonitions not to treat chronic wounds with antibiotics, from a statistical and clinical standpoint it appears that chronic wounds improve when treated with systemic antibiotics, so the issue is a complex one. The jury is still out on the value of topical antibiotics. Although compounded topical antibiotics can be expensive, it is possible to provide topical antibiotics to wounds in an economical way without compounding them. I think we ought to be looking at registry data to understand the impact of antibiotics (both topical and systemic), but the FDA doesn’t seem interested in that question, even though we certainly could answer it with the data we already have.

Recently, I’ve been testing a few of the new antibiofilm agents. I’m not an infectious-disease expert, and I don’t have a dog in this fight. It’s possible that they work. What worries me is the price. Patients have to pay out of pocket for antibiofilm agents since they are not pharmaceuticals, whereas most patients have prescription drug coverage for antibiotics and insurance coverage for dressings. The companies that manufacture antibiofilm agents argue that they allow patients to heal using very inexpensive dressings. This argument does not save patients money if they had to pay out of pocket for the antimicrobial agent but did not have to pay for the dressings. However, I am seeing a scary trend with Medicare Advantage and some other private insurance plans that are not covering surgical dressings. If this trend continues, and it does turn out to be true that using an antibiofilm agent makes it possible to heal a wound with gauze and tape, then the cost of the antibiofilm agent would easily be justified.  

Dressings are becoming an increasingly hot topic for another reason: Currently, the durable medical equipment (DME) companies are under a type of audit known as Targeted Probe and Educate (TPE) by many regional Medicare Administrative Carriers focused on the use of alginate dressings. (My fellow editorial board member Kathleen D. Schaum, MS, addresses some of the most frequently asked questions about TPE in her Business Briefs column in this edition of Today’s Wound Clinic beginning on page 6) Most wound care clinicians know that Medicare’s surgical dressing policy specifies the characteristics of a wound that must be documented in order to justify a dressing in a particular category. Alginate dressings, for example, are used in wounds with moderate to high drainage. If the wound visit note does not provide documentation supporting the need for an alginate dressing, then the DME company can be required to repay Medicare for any alginate dressings that it provided to the patient.² Using USWR data, we analyzed the percentage of time that the dressing ordered by a wound care practitioner was consistent with the Medicare surgical dressing policy, based on the wound characteristics documented at the visit (eg, absorptive dressings in wounds with moderate to high exudate). Care to guess the result? It was 55%, which is not much better than flipping a coin. That doesn’t mean that half of the decisions that wound care practitioners made were bad, but it does mean that, if the practitioner ordered dressings from a DME using his/her documentation that day, half the time the DME could end up having to pay money back to Medicare if it was audited. This is not a small problem. The amount of money at stake is enough to bankrupt a DME company. That’s why the USWR programmed the decision logic for the surgical dressing policy into a DME order system to ensure that dressing orders were consistent with the policy. It’s a logical quality measure for 2018. 

We have big unanswered questions about wound bioburden, antimicrobial dressings, and infection, and we don’t seem to be getting closer to finding the answers. Wound care practitioners are using a lot of antibiotics (both systemic and topical) because they perceive that wounds improve when they use them, and they are not imagining this to be the case. Antibiofilm agents may be a useful addition, but the jury is still out and I am uncomfortable asking patients to pay out of pocket for them as long as other options are covered by insurance. The value of antimicrobial agents will increase as it gets harder to obtain advanced dressings. Antimicrobial dressings are perhaps the most commonly used type of dressing. However, if you ask me, they aren’t working well enough, and I don’t know why. All I know is, every day in my clinic I am reminded of the Dr. Seuss book Green Eggs and Ham. I’ve posted a montage of nasty dressings on my blog for your enjoyment (https://carolinefifemd.com), in case you don’t have enough of your own. I don’t know about you, but I do not like green eggs and ham, Sam I am. 

Caroline E. Fife is chief medical officer at Intellicure Inc.; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands, TX; and co-chair of the Alliance of  Wound Care Stakeholders.

References

1. Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial dressing usage in 3,084 Patients. OWM. 2010;56(3):28-42.

2. Carroll B. Wound care supplier woes. help us help you! TWC. 2018;12(4)[Epub April 5, 2018].