As a wound care practitioner who has specialized in the use of therapeutic technologies for more than 30 years, I have first-hand experience with the confusion regarding the different types of ultrasound used to treat wounds. I am concerned the content in the article (Maher SF, Halverson J, Misiewicz R, Reckling T, Smart O, Benton C, Schoenherr D. Low-frequency ultrasound for patients with lower leg ulcers due to chronic venous insufficiency: a report of two cases. Ostomy Wound Manage. 2014;60:52–61) will add to the existing confusion. This article focuses specifically on the effectiveness of contact ultrasound debridement (Qoustic Wound Therapy System, Arobella Medical, LLC, Minnetonka, MN) in wound healing and draws improper clinical conclusions on the use of ultrasound generally based on a range of both contact and noncontact ultrasound devices.
The authors report on a variety of low-frequency ultrasound (LFU) devices (25 kHz – 40 kHz) delivered through a number of different of mediums (direct contact, water-bath, and noncontact saline mist). As presented, the results are intertwined, making it difficult to distinguish between technologies, so the uninformed reader could easily assume they are all the same. Contact ultrasound debridement devices are used to remove fibrin and slough early in the healing process. Noncontact, low-frequency ultrasound delivered through a saline mist (MIST® Therapy System, Celleration, Inc, Eden Prairie, MN) is used to promote wound healing throughout the healing process. The clinical results discussed in this article demonstrate the markedly different uses and clinical outcomes of these technologies, yet the authors report, “a number of studies utilizing LFU have been published; the results are mixed.” The mixed results are caused by combining study results from different ultrasound devices intended to be used for clearly different purposes.
As clinicians, we are looking for the most efficacious and cost-effective products to heal our patients. The longer we allow data from different ultrasound technologies (LFU contact debriders, LFU water bath, LFU wound healing through saline mist, high frequency) to be inappropriately commingled in our reporting and publications, the more difficult it will be for us to understand which therapy should be applied to a particular patient. On a broader scale, the practice of mixing of data has resulted in a number of inconclusive reports on LFU products, which has caused certain payors to restrict or deny coverage and ultimately limit patient access.
As the manufacturer of MIST® Ultrasound Healing Therapy, Celleration has invested substantial resources to develop a body of evidence that allows clinicians to make evidence-based decisions for their patients. Today, there are 18 peer-reviewed publications (Evidence Level I-III) citing the healing benefits of this product. We have a vested interest in ensuring these clinical data are presented accurately. At the same time, as a member of the wound care community, I believe our responsibility as clinicians is to ensure clinical publications are not only accurate, but also not misleading, whether intentional or not. It is time we recognize the distinctions between ultrasound technologies and no longer allow the reporting of inappropriately grouped therapeutic technologies.
Pamela G. Unger, PT, CWS VP Medical Affairs, Celleration