How to Spot Unproven Claims in OTC Wound Care Product Advertising Protection Status
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by Michel H.E. Hermans, MD

We, the wound care community, are doing it wrong! We are using FDA approved, expensive diagnostics and treatments while the solution for your diabetic foot ulcers, pressure ulcers, full-thickness burns and keloid scars are on the web and cost peanuts in comparison to a visit to your doctor.

Get rid of your keloid? "Quickly dry off area and apply 1-2 drops of Tea Tree Oil directly to the site" and repeat, repeat, repeat." For diabetic, pressure and venous leg ulcers: "Tests show that topically applied lysozyme breaks down more than 650 different types of viruses, fungi, bacteria and disease." It "targets harmful bacteria, while sparing beneficial bacteria." "Coral Reef Sea Salt contains more than 82 trace minerals" and "works in harmony with your immune system." This is considerably better than antibiotics since "According to Gerald Lazarus, MD, professor of dermatology and director of the Johns Hopkins Wound Center, many people end up using the wrong antibiotic, which can breed bacterial resistance and cause contact dermatitis."

Scientific Proof of OTC Wound Care Product Efficacy

The picture below shows "scientific proof" of the superiority of a wound healing product and there is even a book that tells you how to heal (all) scars, seemingly without medical intervention. There is, of course, information about clinical results (but only "on file"); materials are "Doctor Recommended" and tons of testimonials serve as evidence. References are taken out of context, as is no doubt the case with the quote from Dr. Lazarus, who was indeed at Johns Hopkins as Professor of dermatology and their wound care center.


The market for over the counter (OTC) wound care products is massive because there is a need for treatment and regular (real) treatment products are expensive, as are visits to the doctor. Unfortunately, OTC-product regulations are minimal with regard to proof of efficacy and companies can get away with the most incredible claims since they are not FDA regulated (which often is stated in super small print at the end of the ad). Never mind that it takes a trained health care provider with good treatment and good products months to heal a diabetic foot ulcer and that treatment of hypertrophic scars or keloid is very difficult with never completely satisfactory results.

When we use FDA regulated devices and medications, their claims have to be scientifically proven (I do not have a clue what the above picture of the "scientific proof" shows, but it is used as such in one advertisement) and that "burden" is sometimes too big to undertake. As an example: we all know that occlusion reduces pain and speeds up wound healing. However, since these might be pharmaceutical claims wound care companies have to come up with statements such as "assist in the wound healing process" or "helps reduce pain."

Educating Patients About Unproven Claims in Advertising

I am not saying that botanicals, which most of these "magic materials" are, do not work. As an example: MEBO cream is a botanical in use in the Middle East and Asia for the treatment of partial-thickness burns. The material has been tested in properly executed clinical trials and with good results but the exact working mechanisms are not known.

Using unproven claims in an attempt to prey on the pockets of frustrated and desperate patients is, in my mind, unethical. As part of an overall education on wound care, health care providers should educate their patients on not spending money on the numerous magic claims that non-scrupulous companies assign to their products.

About the Author
Michel H.E. Hermans, MD, is an expert in wound care and related topics, trained in general surgery, trauma care and burn care in the Netherlands. He has more than 25 years of senior management experience in the wound care industry. He has conducted a large number of clinical trials relating to devices and drugs aimed at wound care and related indications and diseases. Dr. Hermans speaks internationally and has authored many published works relating to wound management.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

WoundSource ENEWS


good article

Drs Hermans and Lazarus are exactly right. There's so much nonsense written and claimed for OTC wound products. Let the buyer beware! Is it time for the FDA to take an interest? I have no doubt that 'consumers' are obtaining little, if any, benefit from these products.

I agree with the article. And if the etiology of the wound is never addressed it does not matter what wound care product is used.

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