The wound care industry has been inundated with antimicrobial products for years.
Companies with good intentions try to improve outcomes and move away from antiquated antiseptics, such as Betadine, Dakins and acetic acid, that are not actually approved for use in wounds.
But some products are cytotoxic and lack any solid evidence that they are antimicrobial.
Instead, companies are offering modern products with little or no cytotoxicity available in multiple forms, such as cleansers and dressings. The challenge facing you in this barrage of products is knowing whether they are actually antimicrobial in the wound.
This blog will arm you with proper ways to analyze these antimicrobial products and increase knowledge about them.
What constitutes an antimicrobial product?
When I worked in wound care sales, I became familiar with the role of the U.S. Food and Drug Administration (FDA) in wound dressings, cleansers and other products.
Although the FDA can be a stumbling block to getting new products, the agency does ensure companies do not make unproven claims about their products.
A company can’t make claims in writing, such as in brochures or on their website, that have not been substantially proven to the FDA. That is why it is important to thoroughly read this information.
For example, many of these products all put the word “antimicrobial” somewhere on a label, brochure or website, and they are not necessarily misleading you.
What clinicians need to understand is “antimicrobial” does not necessarily mean the product kills microorganisms in the actual wound.
A product can be antimicrobial in several different ways other than killing microorganisms in the wound, such as being a preservative agent in a solution or a barrier to prevent microorganism growth within the dressing.
How do you figure out what each antimicrobial product actually does? Let’s look at four areas to find the answers.
1. Read labels, brochures and websites
Look for any statement that the product can reduce microorganism levels in wounds. The key words there are “in wounds.”
Many companies will use the phrase “kills bacteria,” but that’s where they have to stop. They do not mention where.
Why is that? Because the FDA will not allow them to say “kills bacteria in wounds” when there is no evidence from the studies conducted.
2. Examine how antimicrobial products were tested
There are a number of different types of testing that can be done, such as Preservative Testing (USP 51), in-vitro studies and wound simulated testing.
Preservative testing and in-vitro studies have no correlation with clinical efficacy in wounds, so they are irrelevant in making the case that a product reduces microorganisms in wounds.
With wound simulated testing, it does not guarantee the simulation was truly indicative of a chronic wound environment.
The good news is that the FDA has one test with specific criteria a product must undergo to prove its antimicrobial effectiveness. If the product passes, the FDA will clear the product as antimicrobial.
3. Look for clinical evidence
This requires a critical analysis of studies for accuracy, objectivity and authenticity.
Look for quantifiable measurement of bacteria levels before and after treatment that show a definitive reduction. The only way to show that would require either tissue cultures or the MolecuLight wound imaging device.
A swab of the wound before and after is irrelevant since swabs cannot quantify bacteria levels.
Do not be misled by “correlative” study outcomes, i.e. wounds treated with the antimicrobial product and a non-antimicrobial product in which the antimicrobial product healed faster, thus demonstrating its effectiveness.
4. Read the FDA 510(k) Clearance
The majority of products in the U.S. must receive FDA clearance. A company presents what the product indications are to the FDA, along with any additional claims it wishes to make and the evidence to support it.
The FDA then summarizes for what it “clears” the product. If the product has only proven the antimicrobial agent to be a preservative or a barrier within the product, it will clearly be stated in this form.
You must research all products
I always challenge you as clinicians to do your own due diligence on the antimicrobial products you are considering or purchasing.
Sales representatives for these products can get the answers to do the analysis, but it ultimately falls to you as clinicians to make good choices in the products you use. Your patients deserve as much too.
Learn more in our wound care courses.
What do you think?