J Wound Manag Res.  2019 Mar;15(1):5-10. 10.22467/jwmr.2019.00584.

Portable Ultrasonic Surgery System for Chronic Wounds: A Multicenter Randomized Controlled Clinical Trial and In Vitro Characterization

• Pak C
• Lim J
• Kim BK
• Kim H
• Park S
• Mun GH
• Kim JT
• Jeong JH
• Heo CY

• KMID: 2469754
• DOI: http://doi.org/10.22467/jwmr.2019.00584

Abstract

BACKGROUND
Debridement is a crucial process in wound care. Low-frequency ultrasound debridement is a relatively painless modality that eliminates necrotic tissue, decreases bacterial counts, and minimizes blood loss. ULSC-12D is a lightweight and compact ultrasound surgery system, and SONOCA 180 is a larger conventional system. We compared the efficacy and safety of these two devices in a multicenter randomized controlled clinical trial and conducted relevant in vitro studies.
METHODS
Thirty patients were enrolled in the clinical trial and randomly allocated to two groups: the study group undergoing debridement using ULSC-12D and the control group undergoing debridement using SONOCA 180. Intra-procedural pain and post-procedural reduction of bacteria and necrotic tissue were evaluated. Experimental in vitro studies were performed with three groups: cells treated with ULSC-12D, cells treated with SONOCA 180, and a control group. Cell proliferation, collagen synthesis, growth factor expression, and nitric oxide production were measured.
RESULTS
There were no significant differences in outcome between two clinical trial groups. Both devices provided acceptable necrotic tissue and bacterial reduction, and no significant adverse events were reported. In in vitro studies, ULSC-12D-treated fibroblasts produced significantly more collagen and basic fibroblast growth factor. Fibroblast proliferation rate and endothelial cell nitric oxide production were significantly higher in ultrasound-treated cells, but the differences between device groups were not significant.
CONCLUSION
ULSC-12D is as effective and safe as the more conventional SONOCA 180 for wound debridement and yields superior results to SONOCA 180 in in vitro studies.

Keyword

Ultrasonic therapy; Debridement; Pressure ulcer; Surgical equipment

MeSH Terms

Bacteria
Bacterial Load
Cell Proliferation
Collagen
Debridement
Endothelial Cells
Fibroblast Growth Factor 2
Fibroblasts
Humans
In Vitro Techniques*
Nitric Oxide
Pressure Ulcer
Surgical Equipment
Ultrasonic Surgical Procedures*
Ultrasonic Therapy
Ultrasonics*
Ultrasonography
Wounds and Injuries*
Collagen
Fibroblast Growth Factor 2
Nitric Oxide