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Read Original Release

Wireless electroceutical dressing (WED) touted as novel, but it’s been FDA approved for years

Self-Adhesive Dressing Generates Electrical Current That Promotes Healing, Reduces Infection Risk

Our Review Summary

Electroceutical Wound Dressing. Image: Vomaris

Electroceutical Wound Dressing. Image: Vomaris

This release describes research involving a specialized bandage that directs electrical stimulation to tissue to promote  healing of chronic wounds. Researchers state that the electric field disturbs the ability of some bacteria to develop biofilms which can hamper wound healing and thwart antibiotics. Such bandages would be a boon to patients with problems of chronic wound healing, according to researchers.

Unfortunately, the release doesn’t give us much information about how the latest research findings (from an animal study) differ from previous work, or how this technology improves on the wireless electroceutical devices (WED) already FDA cleared for in use in humans.

The release would have benefited from information on the cost of the bandages, a summary of potential harms, and more quantification of benefits and description of the evidence. Another short-coming was the lack of transparency about the latest research in relationship to previous work funded by a WED manufacturer and Ohio State researchers, who also led this study.

[Editor’s note: Earle Holland, one of three reviewers of the release, is a former senior science communications officer at Ohio State University. While on staff he was not involved in communications concerning Ohio State’s Center for Clinical and Translational Science (CCTS). He has since retired and has no relationship now with the University.]

 

Why This Matters

As the release mentions, millions of Americans suffer from chronic wounds, due largely to conditions such as diabetes, obesity and pressure ulcers, commonly referred to as “bed sores,” afflicting countless elderly in nursing homes. Chronic wounds are a serious challenge to health professionals and their patients so as new technology becomes available to improve and speed healing, it is welcomed as a major improvement to public health.

Wireless electroceutical dressing (WED) is one component in a growing field of medicine called electroceuticals which encompasses medicine that employs electrical stimulation to affect and modify functions of the body. The FDA has already cleared at least one WED, marketed under the trade name Procellera by Vomaris Innovations. That device is green-lighted for treating wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions and graft sites.The WED technology has undergone many research studies in recent years with results published in numerous journals. It would have been nice if the release had clarified Ohio State researchers’ roles in developing Procellera, the earlier WED product.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

In general, if a product is far from deployment, an estimate of its cost could seem premature. However, this release contains the following statement:

“The patch’s design significantly advances existing FDA-approved wireless electroceutical dressing (WED) that harnesses the body’s innate response to injury to help wounds heal.” 

And if it’s not too soon to make a declaration like that, it’s not too soon to estimate what the cost might be. The release might have looked to the cost of existing FDA-approved WEDs to suggest an estimate. For example, this 2015 article on WED in Advances in Wound Care journal by Ohio State University researchers suggests a cost-savings over other wound care methods by reducing the number of dressing changes required per week.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

No quantification of benefits is provided. A scientist is quoted as saying the research takes the technology “to the next level” and that they have “optimized the bandage’s design and the amount of electrical current delivered” allowing “electric fields and currents to penetrate more deeply into wounds, and really get to where these biofilms may be hiding,” but offers no data to support the claims.

In comparing the technology to traditional dressings, the release states that “infected wounds covered by the experimental bioelectric dressing healed better and more quickly than those covered with a plain dressing that is commonly used in the care of wounds today.”  We aren’t given any data on what “healed better”  and “more quickly” actually means.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t mention any potential harms from the technology.

According to an article in DermatologyTimes,Patients who are allergic or sensitive to silver, zinc and/or polyester should avoid using Procellera. In addition, patients undergoing magnetic resonance imaging, electrocardiogram or electroencephalogram should avoid using Procellera.” The information was provided by a physician-consultant to the manufacturer.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

While the release begins by suggesting that chronic wound patients may be getting “good news” soon about this research, it’s not until the eighth paragraph that we learn that the study being touted used animal models rather than human patients. Stating that reported work was done using animal models is a key point that should be emphasized early in any news story or news release, not buried more than half-way through the text. The explanation later in the release stating that the researchers are “hoping to begin testing the new technology in patients before the end of the year to determine optimal treatment duration and more about the healing effects of electrical fields on skin cells on a molecular level,” suggests that the conclusion of the human trials may be a long way off.

Does the news release commit disease-mongering?

Satisfactory

The release does not engage in disease mongering. It also puts chronic wounds in context by stating how many Americans may be affected.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release identifies the funder of this work as the National Institute of Health, and notes that “the team already has interest from several industry partners.”

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release compares the new technology to plain dressings but without comparative data. It states, “Early results, which were presented at the Wound Healing Society’s Annual Meeting in April 2016 indicate that infected wounds covered by the experimental bioelectric dressing healed better and more quickly than those covered with a plain dressing that is commonly used in the care of wounds today.”

It might have been more meaningful to compare this new WED against existing WEDs.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release makes it clear that this research of an “advanced” WED is experimental and the technology has not yet been tested in humans. There’s a strong implication that the bandages won’t be available anytime soon.

Does the news release establish the true novelty of the approach?

Not Satisfactory

As the news release points out, FDA-approved WEDs already exist on the market. What is the real novelty here? We are told:

“The patch’s design significantly advances existing FDA-approved wireless electroceutical dressing (WED) that harnesses the body’s innate response to injury to help wounds heal.”

But the release never explains what these significant advances are.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The opening paragraph of the news release calls the research a “potentially transformative solution” to a serious health problem. It says the “design significantly advances existing FDA-approved wireless electroceutical dressing” and that  “the U. S. Department of Defense is very interested in the dressing.” These statements are basically editorial comment not backed up by any data or supporting information.

Total Score: 4 of 10 Satisfactory

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