BlueCross BlueShield of Tennessee Medical Policy Manual

Non-Contact Ultrasound Treatment for Wounds

DESCRIPTION

Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz). The therapeutic effect of US energy in the kilohertz range has been examined for the treatment of wounds. Non-contact low-intensity US devices (e.g., MIST Therapy™ System) have been developed that do not require a coupling gel or other direct contact. These devices deliver ultrasonic energy to wounds via a saline mist without direct skin contact.

Although the exact mechanism underlying its clinical effects is not known, therapeutic ultrasound has been proposed to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, and collagen production, and increases in macrophage responsiveness fibrinolysis, and nitric oxide levels.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

Current clinical studies do not permit conclusions concerning the effect of this technology on health outcomes. Additional well-designed studies that include relevant outcomes are needed to evaluate this treatment.

SOURCES  

Association for the Advancement of Wound Care (AAWC). (2014, February). Venous ulcer guideline. Retrieved July 15, 2016 from http://aawconline.org/professional-resources/resources/.

Bekara, F., Vitse, J., Fluieraru, S., Masson, R., De Runz, A., Georgescu, V., et al. (2018). New techniques for wound management: a systematic review of their role in the management of chronic wounds. Archives of Plastic Surgery, 45 (2), 102-110. (Level 1 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (2:2021). Non-contact ultrasound treatment for wounds (2.01.79). Retrieved March 2, 2021 from https://www.evidencepositioningsystem.com/. (19 articles and/or guidelines reviewed)

Gibbons, G. W., Orgill, D. P., Serena, T. E., Novoung, A., O’Connell, J. B., Li, W. W., et al. (2015). A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage, 61 (1), 16-29. (Level 2 evidence)

Olyaie, M., Rad, F., Elahifar, M. Garkaz, A., Mahsa, G. (2013). High-frequency and noncontact low-frequency ultrasound therapy for venous leg ulcer treatment: a randomized, controlled study. Ostomy-Wound Management, 59 (8), 14-20. (Level 2 evidence)

Prather, J. L., Tummel, E. K., Patel, A. B., Smith, D. J, & Gould, L. J. (2015). Prospective randomized controlled trial comparing the effects of noncontact low-frequency ultrasound with standard care in healing split-thickness donor sites. Journal of the American College of Surgeons, 221 (2), 309-318. Abstract retrieved July 15, 2016 from PubMed database.

Tricco, A., Jesmin, A., Vafaei, A., Khan, P., Harrington, A., Cogo, E., et al. (2015). Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Medicine, 13, 89. (Level 2 evidence)

U. S. Food & Drug Administration. (May 2005). Center for Devices and Radiologic Health. 510k Pre-market Notification Database K050129 (MIST™ Therapy System). Retrieved August 31, 2015 from http://www.fda.gov.

Watson, J., Kang’ombe, A., Soares, M., Chaung, L., Worthy, G., Bland, M., et al. (2011). Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomized controlled trial. British Medical Journal, 342:d1092. (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  4/4/2011

MOST RECENT REVIEW DATE:  5/13/2021

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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